This document is part of an archive of postings by John Ray on Dissecting Leftism, a blog hosted by Blogspot who are in turn owned by Google. The index to the archive is available here or here. Indexes to my other blogs can be located here or here. Archives do accompany my original postings but, given the animus towards conservative writing on Google and other internet institutions, their permanence is uncertain. These alternative archives help ensure a more permanent record of what I have written.

This is a backup copy of the original blog



Below is the backup of this blog for October, 2023. To access the backups in earlier years, click here



30 November, 2023

No proof face masks ever worked against Covid, claims UKHSA

There is no solid proof masks ever slowed the spread of Covid, England's former deputy chief medical officer said today.

Professor Dame Jenny Harries, who now heads up the UK Health Security Agency, said the evidence that coverings reduced transmission is 'uncertain' because it is difficult to separate their effect from other Covid curbs.

She also told the UK's Covid inquiry that government advice on how to make a mask using two pieces of cloth was 'ineffective'.

Studies showed at least three were needed for even a small effect on the spread of viruses, Dame Jenny said.

Meanwhile, she warned advice for the public to wear masks during the pandemic may even have given people a 'false sense of security' that they could reduce their risk of becoming infected if they wore one while mixing with others.

Dame Jenny wrote in her witness statement that the evidence base for using face masks in the community 'was, and still is to some degree, uncertain'.

She noted that the evidence for mask wearing varied depending on what materials it was made from. For example, a 'one or two layer cloth covering' is 'not particularly effective', she said.

And if someone doesn't wear it properly – fully covering the mouth and nose – 'it won't work', Dame Jenny added.

The inquiry was shown guidance on how people can make their own face masks from the first wave of the pandemic.

In response to the proposals in May 2020, Dame Jenny wrote that advice to use one or two pieces of fabric was 'ineffective'.

She told the inquiry that the evidence at the time said at least three layers were needed 'to give a positive impact' but even this finding 'was not very strong', so the advice was not effective.

Dame Jenny also warned that encouraging people to wear face masks led to a 'false sense of security' that people could mix more closely without risk.

Asked about a Government document recommending the use of face masks in May 2020, Dame Jenny said: 'We've got all sorts of safety issues here as well.

'One of the problems in May was when there were a lot of discussions about coming out of lockdown and opening up the economy and various other things – and the two metre, one metre (social distancing guidance).

'I think this was landing just about the same time as the "one metre plus" issue.

'The problem we had there was that there appeared to be a view permeating through, and a real concern and risk, that it was being conceived that if you did one metre and you wore a face covering slung round your cheek, or whatever it might be, that was fine.

'So, there was a risk that in encouraging face (masks) people would stop doing the thing that was really important, which was distancing and all the other things.'

Asked by inquiry chair Baroness Heather Hallett whether this led to a risk of a 'false sense of security', Dame Jenny replied: 'Yes, a false sense of security.

'But it was actually also overlapping with what was economically-driven policy, I think, to try and remove some of the distancing rules.'

She said, at the time, she and Professor Sir Jonathan Van Tam, England's former deputy chief medical officer, were 'really trying to highlight what we thought about the two metre and one metre rule discussions'.

Dame Jenny added: 'What was being conceived was if you wear a face covering and reduce everything to a metre, the face covering will make up for the difference, and the answer was no, it won't, and it definitely won't if it's ever not evidence based.'

Dame Jenny also revealed that she wrote to cabinet secretary Simon Case in May 2020, when he was No10 permeant secretary, expressing concern that people may believe they 'could go back to normal' wearing face coverings made from t-shirts, when there was no evidence base around the measure.

She told the inquiry: 'The first question was, shouldn't you be encouraging this? There's no harm'. 'The issue for me at that time, and I think Professor Van Tam shared it, was we definitely shouldn't be supporting something which was not evidence-based if it was going to promote a risk compensation.

'Of course, face coverings, as I know you'll be aware, is a wholly polarised debate and it's quite difficult to maintain a central position, if I'd said: "don't do any of this", somebody would have challenged back and said: "Well, surely there's no harm".

'My main concern was it would have been conceived as a safer way of moving about just when we got through the first tragic wave of a pandemic.'

Asked if she did anything about the concern, she added: 'Yes, well on the one metre, two metre (social distancing suggestion).

'I think this is very much around the same time that the CMO (chief medical officer), CSA (chief science adviser) and the two deputy CMOs wrote to Simon Case, because it was around lifting all the different industries and businesses and sectors at the same time.

'The anxiety was that if people just thought they could get a bit of t-shirt, put it around the face and that would solve all the problems and we could go back to normal, that was not going to be a good public health intervention.

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What's the latest on COVID antiviral drugs, and who is eligible?

Australia is experiencing a fresh wave of COVID, seeing increasing cases, more hospitalisations and a greater number of prescriptions for COVID antivirals dispensed over recent months.

In the early days of the pandemic, the only medicines available were those that treated the symptoms of the virus. These included steroids and analgesics such as paracetamol and ibuprofen to treat pain and fever.

We now have two drugs called Paxlovid and Lagevrio that treat the virus itself.

But are these drugs effective against current variants? And who is eligible to receive them? Here's what to know about COVID antivirals as we navigate this eighth COVID wave.

What antivirals are available?

Paxlovid is a combination of two different drug molecules, nirmatrelvir and ritonavir. The nirmatrelvir works by blocking an enzyme called a protease that the virus needs to replicate. The ritonavir is included in the medicine to protect the nirmatrelvir, stopping the body from breaking it down.

Molnupiravir, marketed as Lagevrio, works by forcing errors into the RNA of SARS-CoV-2 (the virus that causes COVID) as it replicates. As these errors build up, the virus becomes less effective.

This year in Australia, the XBB COVID strains have dominated, and acquired a couple of key mutations. When COVID mutates into new variants, it doesn't affect the ability of either Paxlovid or Lagevrio to work because the parts of the virus that change from the mutations aren't those targeted by these two drugs.

This is different to the monoclonal antibody-based medicines that were developed against specific strains of the virus. These drugs are not thought to be effective for any variant of the virus from omicron XBB.1.5 onwards, which includes the current wave. This is because these drugs recognise certain proteins expressed on the surface of SARS-CoV-2, which have changed over time.

What does the evidence say?
As Lagevrio and Paxlovid are relatively new medicines, we're still learning how well they work and which patients should use them.

The latest evidence suggests Paxlovid decreases the risk of hospitalisation if taken early by those at highest risk of severe disease.

Results from a previous trial suggested Lagevrio might reduce COVID deaths. But a more recent, larger trial indicated Lagevrio doesn't significantly reduce hospitalisations or deaths from the virus.

Australia is riding another COVID wave — and the most vulnerable are the least vaccinated
As a new wave of COVID-19 hits Australia, why are so few aged care residents up-to-date with their COVID-19 vaccinations?

However, few people at highest risk from COVID were included in this trial. So it could offer some benefit for patients in this group.

In Australia, Lagevrio is not routinely recommended and Paxlovid is preferred. However, not all patients can take Paxlovid. For example, people with medical conditions such as severe kidney or liver impairment shouldn't take it because these issues can affect how well the body metabolises the medication, which increases the risk of side effects.

Paxlovid also can't be taken alongside some other medications such as those for certain heart conditions, mental health conditions and cancers. For high-risk patients in these cases, Lagevrio can be considered.

Some people who take COVID antivirals will experience side effects. Mostly these are not serious and will go away with time.

Both Paxlovid and Lagevrio can cause diarrhoea, nausea and dizziness. Paxlovid can also cause side effects including muscle aches and weakness, changes in taste, loss of appetite and abdominal pain. If you experience any of these, you should contact your doctor.

More serious side effects of both medicines are allergic reactions, such as shortness of breath, swelling of the face, lips or tongue and a severe rash, itching or hives. If you experience any of these, call 000 immediately or go straight to the nearest emergency department.

Be prepared

Most people will be able to manage COVID safely at home without needing antivirals. However, those at higher risk of severe COVID and therefore eligible for antivirals should seek them. This includes people aged 70 or older, people aged 50 or older or Aboriginal people aged 30 or older with one additional risk factor for severe illness, and people 18 or older who are immunocompromised.

A COVID infection now could spell trouble in three decades
Genes, environment and lifestyle are some of the risk factors for serious diseases like Parkinson's and Alzheimer's. This is why scientists believe COVID-19 infection should be added to the list.

If you are in any of these groups, it's important you plan ahead. Speak to your health-care team now so you know what to do if you get COVID symptoms.

If needed, this will ensure you can start treatment as soon as possible. It's important antivirals are started within five days of symptom onset.

If you're a high-risk patient and you test positive, contact your doctor straight away. If you are eligible for antivirals, your doctor will organise a prescription (either an electronic or paper script).

These medicines are available under the Pharmaceutical Benefits Scheme (PBS) and subsidised for people with a Medicare card. The cost for each course is the standard PBS co-payment amount: $30 for general patients and $7.30 for people with a concession card.

So you can rest and reduce the risk of spreading the virus to others, ask your pharmacy to deliver the medication to your home, or ask someone to collect it for you.

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29 November, 2023

New COVID Variant Spreading in US, Experts Explain Risks
Compared to Eris, BA.2.86 has a significantly lower growth efficiency, meaning that it is less capable of replicating itself in the human bodies.


The new BA.2.86 variant, unofficially known as Pirola is taking hold in the United States.

Between Oct. 28 to Nov. 25, its prevalence increased from 1 to around 9 percent in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC).

The World Health Organization designated Pirola as a variant of interest on Nov. 21, yet it also found the public health risk posed by BA.2.86 to be “low at the global level (pdf).”
In an update published on Nov. 27, the CDC agreed with the WHO’s assessment “that the public health risk posed by this variant is low compared with other circulating variants, based on available limited evidence.”

Current Research Suggests Low Risk of Disease

Pirola is derived from BA.2, an earlier Omicron variant.
Other variants derived from BA.2 include XBB.1.5 which became the dominant strain in early 2023.

The current dominant variant is H.V.1, and it is derived from the variant EG.5, unofficially known as Eris, a previously dominant variant in the United States.

“At this time, BA.2.86 does not appear to be driving increases in infections or hospitalizations in the United States,” the CDC wrote.

Research outside of the United States similarly suggests that Pirola should not be more severe than current variants.

Researcher Yunlong Cao, who holds a doctorate in physical biochemistry from Harvard found that Pirola “exhibits lower cell infectivity” compared to XBB.1.5 and Eris.

A preprint study from Japan found that while Pirola may be more transmissible than Eris a previous dominant variant, it is less likely to cause disease.

Compared to Eris, Pirola has a significantly lower growth efficiency, meaning that it is less capable of replicating itself in the host, the authors wrote.

“This is not the second coming of omicron. If it were, it is safe to say we would know by now,” Bill Hanage, associate director and professor of epidemiology at Harvard wrote on X on Sep. 1 ,when the variant's prevalence was significantly lower.

Prior Infections Gives Immunity Against the New Variant

Compared to BA.2, its ancestral subvariant, Pirola has more than 30 mutations in its spike protein. The virus uses the spike protein to infect human cells.

The substantial number of mutations initially raised concerns among virologists, who feared this variant might partially evade earlier immunity from previous exposure, whether from natural infection or prior vaccination.

However, evidence is still lacking to predict if there will be more immune evasions as well as the severity of future Pirola cases.

Mr. Cao’s own research in mice who have been vaccinated or infected with XBB vaccines showed that the antibodies generated “cannot well recognize and neutralize BA.2.86,” he wrote in a thread posted on the social media platform, X.

However, Pirola had a low cell infectivity, which can affect the variant's transmission, he added.

In discussion of Mr. Cao’s findings, Mr. Hanage agreed that immune evasion is not a definite indication of more severe infection and transmission.

“Any hopeful virus has to have some immune evasion, because almost everyone has immunity,” he wrote.

The most recent research on Pirola's immune evasion abilities comes from a series of reports conducted by researchers at Columbia University.

The first study, published in Nature, tested Pirola, XBB1.5, and Eris spike proteins against antibodies produced from a breakthrough XBB infection.

These antibodies conferred robust neutralizing activity against Pirola. The authors also noted that Pirola's ability to evade immunity was no better than that of XBB1.5 and EG.5.

The same group of researchers then tested antibodies produced from the new XBB1.5 COVID vaccine against several variants, including XBB1.5, Eris, and JN.1, a derivative of Pirola. The findings were published in a preprint.

The authors found that, compared to all variants investigated, JN.1 was the most immune evasive against antibodies produced from the vaccine.

HV.1: The Current Dominant Variant

The current dominant subvariant is HV.1, a new variant derived from Eris. Eris is currently the most dominant globally and HV.1 succeeded Eris as the dominating variant in the U.S. on Oct. 28.

Like Pirola, the WHO has classified HV.1 as a variant with low public health risk. The variant accounted for about 31.5 percent of all cases in the United States as of Nov. 25.

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Is It Possible that COVID-19 Boosters Trigger a Cancer Relapse?

COVID-19 boosters are used to activate the immune response by synthesizing antibodies against foreign pathogens, however, some adverse events have been associated with these boosters. In the aggregate via published case series alone, over two hundred cases of cancer or cancer relapse have been reported yesterday by TrialSite. Yet none of these cases can prove causation (the studies aren’t designed for that), and the incidence remain rare given over 230 million people are considered fully vaccinated in America alone. Regardless, several cases of cancer relapse have been reported after the administration of COVID-19 boosters, according to Angus Dalgleish, a professor of oncology at St.George’s University of London. During an interview, he raised his concerns about the COVID-19 boosters’ long-term consequences, perturbation of the immune system, and the development or relapse of aggressive cancers. TrialSite investigates the reports of cancer related to COVID-19 vaccination.

Dr. John Campbell, a retired British nurse and healthcare educator, interviewed Professor Dalgleish to discuss his insights into boosters, immunity, and cancer risk. The focus of Dalgleish’s extensive research is immunotherapies and cancer vaccines. In this interview, he described his observations on patients suffering from melanoma.

Melanoma is a type of skin cancer that forms in the skin cells called melanocytes. These cells produce melanin which gives color to the skin. The exact cause of melanomas is still unclear, but it is widely accepted that exposure to ultraviolet radiation from sunlight is the reason for the rapid rise in melanoma cases worldwide. It is easy to treat it if it gets detected at an early stage.

Dalgleish’s observations on melanoma patients

Dalgleish observed cancer patients’ response to immunotherapies (use of the body’s own defense system to fight against diseases) and realized that vitamin D deficiency is associated with melanoma. Moreover, he added that improving the body’s vitamin D status can enhance immunotherapy outcomes.

Several studies support Dalgleish’s claim that vitamin D deficiency is associated with melanoma. A retrospective cohort study in 2022 found that vitamin D deficiency is responsible for worsening the overall survival of melanoma patients. Yet observational studies such as the latter cannot necessarily establish causation.

Additionally, an experimental study suggested that vitamin D deficiency is associated with thicker melanoma tumors, which can cause poor prognosis at the time of diagnosis.

Dalgleish also noted that melanoma patients often return with a cancer relapse even after 20 years. By observing their medical history, he noticed that these patients had experienced stress like divorce, bereavement, or bankruptcy, which caused immune suppression for a significant period. He also realized that there was another factor that increased the relapse rate – receiving a COVID-19 booster shot.

According to Prof. Dalgleish, these boosters are meant to enhance the immune response, but the relapse of cancer raises questions about their effect on immune response.

The mechanism behind the increased relapse

Dalgleish suggests the vaccines mostly deal with antibodies while laying more emphasis on the importance of innate immune response by activating T-cells. These cells effectively remove cancer cells and viral-infected cells. Also, these act during the time when the effective adaptive immune response (antibody production) is in the process of developing. T-cell activity reduces with age, particularly after age 55, which increases the incidence rate of cancer in elderly people.

The boosters do not cause the body to make IgG1 and IgG3, which are neutralizing antibodies, instead, they switch to IgG4 antibodies which are less effective in combating infection or disease. These IgG4 antibodies suppress the T-cell response which causes a suppression in the fast-acting innate immune response. This, according to the hypothesis, increases the chance of cancer relapse in people after getting COVID-19 boosters. But this would need to be fully investigated for any affirmative declarations, would it not?

Immune system perturbation linked to cancer

Dalgleish mentioned that there are many unnecessary antibodies formed inside the body following COVID-19 boosters. He called this “antibody-dependent enhancement.”

Antibody-dependent enhancement refers to a situation in which antibodies emerge during an immune response but do not prevent an infection. Instead, these antibodies actually help the virus penetrate the cells. Thus, Dalgleish claimed that boosters do not provide protection instead, they perturb the immune system and cause more aggressive forms of cancer. He gave an example case of lymphoma diagnosis in one of his colleagues after vaccination.

The London-based oncologist implies of the possibility of emerging cancers such as B-cell leukemia and renal cancers in the near future due to immune system perturbation induced by vaccines. Again this would need to be formally studied, as the observations of one physician or even a handful doesn’t equate to evidence.

Potential impacts of mRNA vaccines on the immune system

In the interview, Dalgleish also talked about mRNA vaccines. He expressed his frustration over the use of the SV40 promoter in mRNA vaccines and explained that it is an oncogenic promoter used for developing cancer in mice.

The oncologist suggests questions about the composition and potential risks of mRNA vaccines. He also extended his concern to the integration of DNA. TrialSite previously published an article analyzing these claims of DNA contamination in Pfizer and Moderna mRNA-based COVID-19 vaccines. While numerous activists critical of the COVID-19 vaccines have pounced on “plasmidgate,” TrialSite has been clear that some of the studies are questionable—such as the German study where most of the vaccine vials were opened upon arrival at the third-party lab doing the testing.

Given the testimony of Professor Philip Buckhaults in front of the South Carolina Senate on the matter TrialSite has suggested formal, government, and industry investigations.

TrialSite’s founder Daniel O’Connor, an expert in Food and Drug Administration (FDA) regulated clinical research process and technologies, was in touch with leadership at the regulatory agency who committed to passing along the information. But the TrialSite publisher told this writer, “The regulators don’t seem too concerned at all about the reports of DNA snippets in the vaccine samples.”

What about the Spike Protein?

There are claims that the spike protein, which was held responsible for vaccine injuries, remained at the injection site and did not integrate. The formal narrative has it that the spike protein flushes from the lymphatic system within a week or so but enough published material has emerged to refute that oversimplified claim.

Dalgleish challenges the premise powering claims for a lack of spike integration.

To examine these claims, autopsies need to be done but Dalgleish points to the difficulty of doing autopsies on patients who had died after vaccination. He said that it had been overruled despite obtaining relatives’ consent for post-mortems. This caused a lack of transparency.

Censorship and media influence also represent formidable issues because the government discouraged criticism of vaccines argues the oncologist. This hinders open discussions about vaccine safety and effectiveness.

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28 November, 2023

Covid-19 cover-up exposed – at last

SHARRI MARKSON

It’s astonishing to consider that Anthony Fauci stood on the White House podium in early 2020, beside the president of the United States, and resolutely told the world that Covid-19 was a natural virus.

Curiously, he failed to mention that his agency had funded coronavirus experiments in Wuhan so dangerous that they had been banned in the US by the Obama administration. Fauci knew, too, that eminent scientists privately harboured concerns Covid-19’s genetic sequence had unusual features inconsistent with evolutionary theory.

Yet he reassured the public that there was no reason to suspect a laboratory incident in Wuhan and, as he did so, Fauci cited as evidence a new scientific paper.

Far from being a conclusive, rigorous scientific study, it was, in fact, a piece of commentary that had been rejected from a prestigious medical journal.

This is not to blame Fauci for the pandemic, although his agency may have funded the research which created Covid-19.

The culpability truly lies in Wuhan where scientists were pushing the boundaries of acceptable experimentation on coronaviruses to make them more infectious and transmissible to humans.

For years the scientists at the Wuhan Institute of Virology had been playing God, and had grown increasingly bold and, as it turns out, shockingly careless, conducing their almost existential experiments in low-security laboratories.

But Fauci’s role in claiming the virus was natural, when he had no incontrovertible evidence to make such a claim, goes to the very heart of the cover-up over the origins of Covid-19. Instead of advancing the world’s understanding of what was unfolding, he was deliberately covering it up and, in doing so, ­creating confusion that crippled the world for years.

He also led desperate and diabolic anti-scientific efforts to shut down investigation into the origins of Covid-19; so anxious was he to divert attention from a lab leak and what would surely follow – accountability of him and his agency.

The early insistence of zoonosis from a such an esteemed and trusted figure saw the lab leak theory assigned to the conspiracy pile, censored by tech giants and ridiculed by the media.

Unravelling the web of cover-ups, conflicts of interest and false narratives surrounding the origins of Covid-19 has been a large part of my life over the past 3˝ years.

I’ve written an investigative book, created a documentary and a podcast and written dozens and dozens of newspaper articles, features and television reports.

I’ve interviewed hundreds of scientists, government officials, investigators, intelligence agency insiders and whistleblowers from all over the world. They each share a common determination; to discover the truth of the origins of Covid-19.

Piecing together information from these individuals has helped to form a more complete picture of what we know about how the first pandemic in 100 years began.

As we near the fourth anniversary since Covid shook the world, there’s a new chapter in this investigation – a documentary airing on Tuesday night on Sky News called What Really Happened in Wuhan, the Next Chapter.

For the first time, Fauci’s boss, the former assistant secretary for preparedness and response, Dr Robert Kadlec, fronts the cameras to divulge their confidential conversations where they decided it would be best if they downplayed the possibility of a lab leak.

Ostensibly, this was to encourage co-operation from China, but Kadlec believes Fauci had reason to protect his own reputation and that of his institute which had funded research in Wuhan.

Haunted by the downstream effects of the decision they made to divert attention away from accusations of a lab leak, Kadlec says he still lies awake at night, reflecting on what they did.

So eager were scientists to shield China from any suggestion its scientific research had started the pandemic, and to protect their own research from being subject to new regulations, there was complicity among international scientists in downplaying or rejecting the lab leak theory.

As a result, there have been no moves to regulate or ban gain-of-function experiments on coronaviruses or other pathogens with pandemic potential globally.

Yet scientists from the four groups within the US intelligence community that engage in scientific analysis all concur that SARS-CoV-2 was most likely ­genetically engineered.

In our new documentary, Kadlec warns that another pandemic could easily eventuate because the lessons haven’t been learned from Covid-19.

For all the excessive government intervention during the pandemic, the most fundamental step of having a conversation about whether scientists should stop dangerous experiments on coronaviruses hasn’t taken place.

It’s also incomprehensible that an event that killed seven million globally would not be deemed significant enough for our world leaders to raise at a diplomatic level with China.

It’s bewildering that there has been no serious investigation into the origins of Covid-19.

It speaks to the lack of courage and political conviction of our world leaders that it’s been left to congressional subcommittees, journalists and internet sleuths to investigate the most consequential period of our lifetimes.

And so, this latest Sky News documentary on Tuesday night plays a role in moving the public debate on this topic forward, providing fresh information about the scientific research that may have started the outbreak in Wuhan, and airing more staggering claims of how public debate was silenced at the highest levels.

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Government Deceit

John Stossel

“Experts” were confident that they knew what America should do about COVID-19. They were wrong about so much.

Officials pushed masks, including useless cloth ones. Dr. Anthony Fauci said, “Don’t wear masks”—then, “Do wear them.”

Some states closed playgrounds and banned motorboats and Jet Skis. Towns in New York banned using leaf-blowers. California pointlessly closed beaches and gave people citations for “watching the sunset.” The list goes on.

Sen. Rand Paul’s new book, “Deception,” argues that government experts didn’t just make mistakes; they were purposely deceitful. A few weeks ago, this column reported how Paul, R-Ky., was correct in accusing Fauci of funding virus research in Wuhan and lying about it.

In my new video, we cover other government deceit.

Paul says, “There’s been one set of truths in private and another set of truths for the people who aren’t smart enough to make their decisions.”

He points out that Fauci, in private, told fellow bureaucrats that masking is pointless. Fauci wrote in one email: “The typical mask you buy in the drug store is not really effective in keeping out virus, which is small enough to pass through the material.”

But in public, complains Paul, Fauci would sometimes wear multiple masks.

“Things that have no scientific basis in fact. … There’s two sets of information going out, one privately and one publicly.”

“Why?” I ask.

“They think that there could be hysteria. They’re in government. They need to do something. … So let’s get everybody occupied with wearing masks. … But in the end, the Cochrane analysis looked at 78 randomized studies and found that masks didn’t work at all.”

“N95 masks may work,” I say.

“The Cochrane analysis looked at the N95 and found they didn’t work very well,” Paul replies.

Another mistake: The virus is 500 times more likely to kill people ages 65 and up than kill kids. But our government told parents: Mask your children. Some states kept kids out of schools for two years.

Also, “When they approved the third vaccine for children,” says Paul, “the first committee was the [Food and Drug Administration] committee. … They came out with the advice: 65 and older. Nobody else. The [Centers for Disease Control and Prevention] had another vaccine committee. … They said the same thing … [but] Rochelle Walensky, a political appointee of [President Joe] Biden, overrode both scientific committees and said the vaccine booster should be given to six months and up.”

“Why? What’s the motivation?” I ask. “Get more people frightened, and then they’ll take the vaccine and that will save America?”

Paul says, “I think most of them are not very smart and they just blindly think, ‘Take the damn vaccine, shut up and take it. It’s good for you.’”

Has he been vaccinated?

“God gave me my vaccine.” He tells me. “I was naturally inoculated. But members of my family, my wife, got vaccinated. We’re not against the advice.”

I clarify, “‘Naturally inoculated,’ meaning you got COVID?”

“I had COVID, so I have immunity,” he replies.

At the start of the pandemic, Sweden’s health officials did not shut down restaurants or other businesses. They also announced that they would not close schools for younger children.

For doing that, Sweden was repeatedly trashed by American government officials and the media. Time magazine called Sweden’s plan “a disaster.”

But the Swedish approach was right! Not only did Sweden escape the economic and social harm of lockdowns, but its COVID-19-related death rate was lower than that of most other countries.

“It turns out they did as well, or better, than most parts of Europe,” says Paul.

“Better,” I point out.

“They also didn’t mandate masks in schools [or] close the schools. Everything we did in this country was wrong.”

I push back. “On balance, vaccines were a good thing. They work for older people, people my age.” In fact, Republican anti-vax “messaging may have killed people!” Before the vaccine came out, an equal number of Republicans and Democrats died. But once the anti-vax messages spread, Republicans had a higher death rate.

Paul replies, “Vaccine hesitancy comes from people’s disbelief in government.”

He adds, “I think people learned from this … [learned] what to trust and what not to trust. People will be smarter the next time around.”

https://www.dailysignal.com/2023/11/15/government-deceit/ ?

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27 November, 2023

Interesting Swedish study

Lots of vaccinated people got Covid but vaccination did tend to protect them from long Covid

A large, population-based cohort study-- part of the project SCIFI-PEARL, a nationwide linked multi-register, observational study of the COVID-19 pandemic in Sweden—was organized to investigate the effectiveness of primary COVID-19 vaccination, defined as the first two doses plus the first booster dose (3 doses) within the recommended schedule targeting post-COVID condition (PCC) another term for long COVID. The study included all Swedish adults aged 18 years and up with COVID-19 first registered between December 27, 2020, and February 9, 2022, totaling 589,722 persons across the Scandinavian nation’s two largest regions. Capitalizing on a health system with rich data collection and management, the study team monitored the study participant data from one of the following data points whichever came first: COVID-19 infection until death, emigration, vaccination, reinfection, a PCC diagnosis—based on ICD-10 diagnosis code U09.9, or end of follow-up period which was November 30, 2022. In the study, persons receiving at least one dose of COVID-19 vaccine prior to infection were deemed vaccinated. The study authors represented by corresponding author Maria Bygdell, a research fellow and Doctor of Medicine with the University of Gothenburg, and colleagues established a primary endpoint of PCC (long COVID) clinical diagnosis, while the team employed use of Cox regressions adjusted for age, sex, comorbidities (e.g. diabetes, cardiovascular, etc.), number of healthcare contacts during 2019 and other socioeconomic factors plus virus variant prevalent at time of infection for the study. While this observational study cannot prove causation, and the study has some glaring limitations (don’t factor in reinfection) the outcomes demonstrate a robust association between COVID-19 vaccination prior to infection and lower risk of PCC (long COVID) diagnosis.

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Excess mortality and Covid vaccination: is there a correlation?

Since the introduction of Covid vaccines, the official narrative in Australia (and other parts of the world) is that these vaccines are safe, efficacious, and working well. However, this claim is considered to be untrue, as demonstrated by both the science and the statistics.

There is compelling evidence that the official narrative promoted by politicians and health bureaucracies, and enforced by politicised police forces, is misleading and even irresponsible in the light of the demonstrable side-effects of mRNA vaccines.

The Australian government effectively treated any reasonable concern about the safety of Covid vaccines as a form of domestic terrorism. From 2017 to 2022, the Department of Home Affairs petitioned social media sites to censor information about these matters no less than 13,646 times. This included suppressed Covid posts from doctors who disagreed with, or even questioned, official public health and vaccine information.

Especially egregious was the admonishment and de-registration of Australian medical doctors who attempted to provide vaccine exemptions or prescribe alternative medicine to alleviate or prevent Covid. ‘The conclusion taken from the collective authoritarian decisions is that medical choice is no longer a prerogative of the doctor-patient relationship in Australia,’ said Robert Clancy AM, a clinical immunologist and emeritus professor of medicine.

We now know that mRNA vaccines prevent neither infection nor transmission of the Covid virus. For example, a recent study by Cleveland clinic researchers concluded that people who received two or more doses of the vaccine were more likely to get infected with Covid. They found that, among 48,344 working-aged clinic employees, those not ‘up-to-date’ on vaccination had a lower risk of Covid than those ‘up-to-date’.

‘If a vaccine fails to stop disease transmission, then the idea that you need to vaccinate other people so that I’m protected is just false,’ said Dr Jayanta Bhattacharya, a professor of medicine and health research and policy at Stanford University.

To make it worse, a comprehensive comparative research analysis has found that Covid vaccines are directly associated with the disturbing rise in the mortality rate among countries of the Southern Hemisphere.

Denis Rancourt is a former professor of physics at the University of Ottawa. Maurine Baudin has a PhD in microbiology from the Université Paris Sud (Paris XI). Joseph Hickey is a data research scientist with a PhD in Physics. Jérémie Mercier is a chemist and health educator with a PhD in environmental research. Together these researchers have recently produced an empirical research paper entitled Covid vaccine-associated mortality in the Southern Hemisphere.

17 countries were studied by these researchers: Argentina, Australia, Bolivia, Brazil, Chile, Colombia, Ecuador, Malaysia, New Zealand, Paraguay, Peru, Philippines, Singapore, South Africa, Suriname, Thailand, and Uruguay). Together these countries comprise 9.10 per cent of worldwide population and 10.3 per cent of worldwide Covid vaccinations (vaccination rate of 1.91 injections per persons, all ages) through virtually every vaccine type and manufacturer.

According to these researchers, ‘All-cause mortality by time is the most reliable date for detecting and epidemiologically characterising events causing death, and for gauging the population-level impact of any surge or collapse in deaths from any cause.’ In these 17 countries, they found no evidence of any beneficial effect of Covid vaccination on all-cause mortality, nor any proportional reduction in the mortality rate. On the contrary, the opposite is true.

In that research paper, the authors also showed that every country with sufficient mortality data (Australia, Bolivia, Brazil, Chile, Colombia, Ecuador, Malaysia, New Zealand, Paraguay, Peru, Philippines, Singapore, South Africa, Thailand, and Uruguay) invariably exhibited an unprecedented and relatively sharp peak or surge in all-ages deaths during or after January-February 2022, which was synchronous with or immediately preceded by a rapid rollout of a Covid vaccine booster, dose 3 or 4, depending on the country.

Regarding the evidence provided in support of causality and toxicity, the authors of this research paper include examples where no detectable excess mortality occurred until the vaccines were rolled out, thus concluding that ‘it is well-established that Covid vaccine injections have caused and are likely to cause the deaths of individuals’. These researchers, in their own words:

‘…have found no evidence in [their] extensive research on ACM [All-deaths Cause Mortality] that Covid vaccines had any beneficial effect. If vaccines prevented transmission, infection or serious illness, then there should have been decreases in mortality following vaccine rollouts, not increases which were observed in every elderly group subject to rapid booster rollouts. And, mortality would not have increased solely when vaccines were rolled out, where no excess mortality occurred prior to vaccine rollouts, as we have documented in 9 countries across 3 continents.’

These researchers previously reported several instances in which anomalous peaks in all-cause mortality appear to be associated with rapid Covid vaccine-dose rollouts, as well as instances where the start of the vaccination campaign coincided with a new period of sustained elevated mortality. These are countries in which, for approximately one year after the WHO’s 11 March 2020 declaration of a pandemic, ‘there were no net extra deaths that could be attributed to a pandemic or to pandemic-response medical or government measures’.

Since the excess mortality in these countries occurred only after vaccine rollouts, the authors conclude that these vaccines certainly did not reduce serious illness (as claimed by manufacturers) enough to reduce any risk of death. On the contrary, according to them, there is strong evidence for a causal correlation between rapid first-doses and booster rollouts and immediate peaks in all-cause mortality, including peaks of mortality in seasonal cycles when peaks never occur. These findings appear to be conclusive and indicate that such vaccines lead to the deaths of individuals, which the researchers then remind us has already been demonstrated by:

Many detailed autopsy studies (reference provided)

Adverse effect monitoring (reference provided)

Studies of vaccine-induced pathologies (reference provided)

An established causal link to vaccine-induced pathology, by histopathology and immunohistochemical staining of skin biopsy specimens (reference provided)

Secondary analysis of serious adverse events reported in placebo-controlled, industry phase III randomised clinical trials (reference provided)

More than 1,250 peer-reviewed publications about Covid vaccine adverse effects (reference provided)

The known vaccine injury compensation programs of states worldwide, which include death resulting from the Covid vaccines (reference provided)

All 17 countries in their comparative research analysis had transition regimes of high all-cause mortality after the vaccines were deployed and administered. Accordingly, unprecedented peaks occurred precisely in January-February of 2022, which are synchronous with rapid booster-dose rollouts of Covid vaccination. The clearest example provided is the sharp all-cause mortality peak occurring in January-February 2022 in Australia, which is concomitant with the rapid rollout of dose 3 of the vaccine in the country.

Like Australia, countries such as Chile and Peru had a sharp all-cause death peak occurring over that same period, which is concomitant with the rapid rollout of Chile’s dose 4 and Peru’s dose 3 of the vaccine. In fact, the authors found the same phenomenon everywhere that data was available, thus making these findings rather conclusive. ‘There can be little doubt that the mass Covid vaccination campaigns caused the temporally associated excess mortality in the 17 countries of the present study, and in other countries studied to date.’ Accordingly, ‘There occurs an onset or increase of a large excess ACM on rolling out the Covid vaccines, in every country and state or province, studied to date, on virtually all continents, including for initial rollouts…’

Rancourt et al are therefore satisfied that the information available extensively demonstrates that Covid vaccines can cause death and that they did not save lives. On the contrary, these vaccines appear to be lethal toxic agents ‘with a high degree of certainty’. This leads the authors to state that adverse-effect monitoring, clinical trial reports, and death-certificate statistics have greatly underestimated the fatal toxicity of Covid vaccines.

These concerns are too serious to ignore. The suspicion that some people have been misled about the safety and efficacy of these vaccines has been further strengthened by the empirical data. The potential for severe injury by these vaccines is a matter that deserves more serious reflection. None were more instrumental in causing this tragedy than the Australian government and their loyal mouthpieces in the media. According to Professor Clancy,

‘The media has a concerning role in the propagation of misinformation, preferring to support an ideologic narrative, rather than to engage in responsible journalism. Misinformation driven by pharmaceutical companies to protect their vaccines, and strongly reinforced by academic, government and health authorities, leads to many unnecessary hospital admissions and deaths’.

So, the question is: Have the Australian governments and the mainstream media colluded in order to ensure an increase in Big Pharma’s corporate profits, which however, does not prioritise the protection of public health?

Be that as it may, it is increasingly difficult to hide the fact that people have died from these vaccines. The tragic consequences of mandatory vaccination are now all too visible in our society.

Above all, we are convinced that it is important to open up this type of conversation, lift the media suppression, and eliminate the muzzling and penalties imposed on those with alternate views or with a desire to promote further discussion. Then society will have to work out the issues of blame and penalties.

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26 November, 2023

Britain's Covid Inquiry has unmasked the flaws in trusting ‘the science’

There is something therapeutic and healing in watching Professor Chris Whitty give evidence to the independent public inquiry into the Covid pandemic – the sense of calm emanating from the man, his occasionally Panglossian self-satisfaction, his refusal to become anything more than barely ruffled even when his interlocuters gently venture forth the suggestion: ‘Overreaction?’ The impression one gets, or perhaps is supposed to get, is of a very clever, terribly rational man in a world full of thicko scumbags.

This lack of debate was exacerbated in the country at large by that curse of our age, political polarisation

I watch a little daytime TV at the moment as part of my rest and recuperation programme following that car crash I mentioned a couple of weeks ago. More usually it is one of the quiz shows, such as Tipping Point, where the contestants are from the very opposite end of the intellectual scale to Chris and can only enrage with their stupidity. No, Shenille – sadly, Tony Blair was not prime minister at the time of the Battle of Trafalgar. Listening to Whitty’s comforting emollience, I can almost feel my hitherto distraught muscles knitting back together, repairing themselves, filling with blood and blooming. He is like a very expensive balm.

What we learn from this inquiry – that the scientists are convinced we should have imposed lockdown earlier and harder, for example – is maybe less interesting than what one might read between the lines. Or, as those scientists would disdainfully put it, speculation. The first and most obvious thing is the withering contempt in which the scientists held the politicians, which must surely have made the management of the pandemic more problematic than it needed to be.

We can infer this from the testimony of the former chief scientific adviser Sir Patrick Vallance, for example. With scarcely disguised scorn, Vallance suggested that science was not Boris Johnson’s ‘forte’ and that the then prime minister needed to have fairly simple graphs explained to him over and over again until he finally grasped the point. This contempt occasionally broke cover during that long, rather wonderful summer of 2020, not least over Rishi Sunak’s fairly ridiculous Eat Out to Help Out scheme, with newspapers reporting disquiet among the Scientific Advisory Group for Emergencies (Sage) at one or other governmental misstep. In fairness to the scientists, they were dealing with a government which had chosen the intellectual titan Matt Hancock to be in charge of the country’s health, which he did with a kind of messianic idiocy.

The second is the make-up of that very committee, Sage – the people who for a year or so effectively became our unelected government. Its membership was rather closely confined and, during cross-examination, Whitty admitted that at first it was probably too narrow in its membership. According to him it later became much broader, but when asked more specifically about who might have been co-opted to give a differing view, he channelled Dr Pangloss again and suggested that in theory an infinite number of scientists might have been invited to provide their expertise, but that too many voices would have made consensus more difficult to achieve. Hmm – this is rather the problem, the nature of that consensus. Whitty admitted – indeed stated almost with pride – that no economists had been consulted, for example.

The issue here is that too great a proportion of the scientists had intellectual skin in the game. Science is perhaps mankind’s greatest achievement, but we sometimes forget that it is practised by humans, with all their frailties and inclinations. The point being that Sage may have been providing the government with advice with which all or most epidemiologists might concur – but without the corrective advice that might be provided by an economist or, for that matter, an oncologist. The advice was always about the immediate, and while Whitty insisted that he and his colleagues were at pains to alert ministers to the potential downsides of action taken to prevent the spread of the virus, we might infer that those downsides were flagged up with rather less avidity than would have been the case if the committee had heard from one or two dissenting voices from different scientific disciplines.

This lack of debate was exacerbated in the country at large by that curse of our age, political polarisation: many of those who might have raised a warning about the long-term effects of sequential lockdowns – the teachers, for example – were too often ideologically committed to what became the leftish view that no lockdown could possibly be sufficiently stringent and they should continue ad infinitum. We have seen more recently the effect this has had on schoolchildren.

Faced with this, one understands a little better the mindset which seems to have established itself in our politicians, including the mindset which led them to enjoy riotous parties when everybody else was confined to barracks. They were given advice which was far, far too narrow and, put simply, they didn’t entirely trust it. Vallance remarked that Johnson had particular difficulty understanding the consequences of government interventions (such as lockdowns) on the spread of the virus. My suspicion is the former PM was at heart deeply sceptical – for ideological as well as perfectly rational reasons – about these interventions and needed convincing that he was being told the
unvarnished truth.

In short, it was a government that had pledged to ‘follow the science’ but was always doubtful about its veracity. The final break came when Johnson refused to impose a lockdown during the Christmas of 2021, a decision which history suggests was unquestionably correct: the scientists at the time begged to differ and of course the Scots went their own way. The lesson to be learned, I reckon, is that it is no use following the science if the science comes from only one direction and there is no open debate about its efficacy or otherwise./>

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Virology poses a far greater threat to the world than AI

Matt Ridley

Sam Altman, the recently fired (and rehired) chief executive of Open AI, was asked earlier this year by his fellow tech billionaire Patrick Collison what he thought of the risks of synthetic biology. ‘I would like to not have another synthetic pathogen cause a global pandemic. I think we can all agree that wasn’t a great experience,’ he replied. ‘Wasn’t that bad compared to what it could have been, but I’m surprised there has not been more global coordination and I think we should have more of that.’

He is right. There is almost no debate about regulating high-risk virology, whereas the world is in a moral panic about artificial intelligence. The recent global summit at Bletchley Park essentially focused on how to make us safe from Hal the malevolent computer. Altman has called for regulation to stop AI going rogue one day, telling Congress: ‘I think if this technology goes wrong, it can go quite wrong… we want to be vocal about that. We want to work with the government to prevent that from happening.’

Bad actors worldwide know how easy it would be to use virology to bring the world economy to its knees

In contrast to that still fairly remote risk, the threat the world faces from research on viruses is far more immediate. There is strong evidence that Covid probably started in a laboratory in Wuhan. To summarise: a bat sarbecovirus acutely tuned to infecting human beings but not bats, which contains a unique genetic feature of a kind frequently inserted by scientists, caused an outbreak in the one city in the world where scientists were conducting intensive research on bat sarbecoviruses. That research involved bringing the viruses from distant caves, recombining their genes and infecting them into human cells and humanised transgenic mice; three of the scientists got sick but no other animals in the city did.

Yet calls to regulate this frankly idiotic corner of virology – gain-of-function research on potential pandemic pathogens – are met with libertarian shrieks of outrage from scientists that even the new President of Argentina would be embarrassed by: leave us alone, we know what we are doing! Most of us were blissfully unaware that a small handful of virologists were being handed huge sums by the US and Chinese governments to see if they could find a virus capable of causing the next pandemic and bring it to a big city, then juice it up in a low–biosafety lab. Only governments, by the way, would fund that kind of work: no venture capitalist would touch it.

Yet now, compared with four years ago, the risk from such research is bigger, not smaller. Even if the recent pandemic did not begin in the Wuhan lab, the fact it could have done has alerted bad actors worldwide to how easy it would be to use virology to bring the world economy to its knees. From Pyongyang to Tehran to Moscow, ears have pricked up. The research proposal writes itself: ‘Dear Kim/Khamenei/Vladimir, if we don’t do this research our enemies will. Please can we hire some virologists and start sampling bats?’

It’s not just rogue regimes thinking this way. So are criminals. Last month, in Fresno, California, police arrested a Chinese national, who had changed his name multiple times, on charges of selling misbranded Covid-19 tests. That allegation is the tip of the iceberg. According to a report from a congressional committee, the man – part of a transnational criminal enterprise funded from China and on the run from a court ruling in Canada – was operating a large, chaotic, secret laboratory in which were found samples of viruses including Covid, HIV, hepatitis B and C, dengue and rubella, plus, according to a label on a freezer, ebola. Oh, and a thousand genetically engineered mice.

When the story first surfaced, after a council officer in the small town of Reedley in California spotted a garden hose leading into the warehouse, the Centers for Disease Control and Prevention seemed remarkably uninterested. The CDC declined to test some of the samples before they were destroyed, so we do not know whether there was ebola in that freezer or not. The media moved to damp down ‘conspiracy theories’ that this was a Chinese government operation to start another pandemic. All those transgenic mice, the Associated Press told us, were ‘simply used to grow antibody cells to make test kits’. Right.

Even if he was just a rogue criminal with no connection to the Chinese government, it is alarming because, as the congressional committee put it, ‘a disturbing realisation is that no one knows whether there are other unknown biolabs in the US because there is no monitoring system in place [and] the US currently does not conduct oversight of privately funded research, including enhancement of potential pandemic pathogens’. There could be labs like this all over America, let alone Asia.

I find myself in a strange position here. I usually argue that regulation stifles innovation far more often than it encourages it, and that tying things like genetically modified crops up in impossible red tape has done great harm. Golden rice – genetically enhanced with vitamin A precursor – could have saved half a million lives a year in the 24 years since it was invented by the Swiss biotechnologist Ingo Potrykus, for example. But Greenpeace campaigned relentlessly against it, pushing governments to impose impossibly tight regulation, a stance that more than 150 Nobel Prize winners have condemned in strong words: ‘How many poor people in the world must die before we consider this a “crime against humanity”?’

Yet when a genuine risk is posed by one small part of virology, those of us calling for more regulation are somewhat lonely. Led by Bryce Nickels of Rutgers University, a group of scientists have founded an organisation called Biosafety Now but they are getting scant support from the scientific establishment. Greenpeace has, as far as I can tell, said nothing about that irresponsible research in Wuhan.

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New Zealand Government to End All COVID-19 Vaccine Mandates

The incoming New Zealand government, under Prime Minister-elect Christopher Luxon, has brokered a historic deal with New Zealand First, led by Winston Peters, to terminate all COVID-19 vaccine mandates and establish an inquiry into the pandemic.

Although Employment New Zealand currently reports no government vaccine mandates at present, it acknowledges that some employers may still require vaccinations based on health and safety legislation.

During COVID-19, while Jacinda Ardern was prime minister, New Zealand introduced vaccine mandates for workers in certain settings and a vaccine pass for the public.

Chris Hipkins, who was a health minister during COVID-19, took over from Ms. Ardern as Prime Minister in January.

During the election campaign, he sparked a massive reaction online when he claimed "there was no compulsory vaccination."

In addition to ending vaccine mandates, an urgent and comprehensive independent COVID-19 inquiry will be conducted, featuring both local and international experts. The inquiry will look into how the COVID-19 pandemic was handled in New Zealand, including the use of multiple lockdowns and the efficiency of vaccine procurement.

Ahead of the election, Mr. Peters campaigned for possible vaccine compensation for those who lost their jobs or were proven injured by the vaccine.

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23 November, 2023

An Open Letter To The Lancet

The Lancet is prestigious and publishes some good studies but it is under heavily Leftist influence. It published, for instance, an article that criticized the American invasion of Iraq. And Leftists like the authoritarian responses to Covid. They took the heavy-handed Chinese Communist approach as their model

A Lancet paper has made outrageous claims that Covid vaccines are highly effective in reducing Covid and all-cause mortality for older Australians. This paper, used by the Australian Government to support more boosters for the elderly, is debunked in the following open letter:

Open letter to Bette Liu, Sandrine Stepien, Timothy Dobbins, Heather Gidding, David Henry, Rosemary Korda, Lucas Mills, Sallie-Anne Pearson, Nicole Pratt, Claire M. Vajdic, Jennifer Welsh, and Kristine Macartney, authors of “Effectiveness of COVID-19 vaccination against COVID-19 specific and all-cause mortality in older Australians: a population based study”. The Lancet, Vol. 40, 100928, November 2023. DOI: https://doi.org/10.1016/j.lanwpc.2023.100928

also to Richard Horton (editor of the The Lancet)

and Paul Kelly (Australian Chief Medical Officer)

Concerns Regarding Data Integrity And Analysis
The retrospective, observational study of 3.8 million Australians of over 65 years, during eleven months of 2022, has reached the following broad conclusion:

“COVID-19 vaccination is highly effective against COVID-19 mortality among older adults although effectiveness wanes with time since the last dose.

Our findings emphasise the importance of continuing to administer booster doses, particularly to those at highest risk.”

This paper and its conclusion have been cited by the Australian Chief Medical Officer in an Australian Senate Estimates inquiry [1] to support government policy of continued vaccination for older adults.

The research has been funded by the Australian Government through various government agencies and by pharmaceutical companies.

As it stands, the conclusion of the paper is unclear, if not invalid, because it states that vaccination is “highly effective”, but “wanes over time”. Can a vaccine be “highly effective” only for a limited time? How limited?

The time limit to effectiveness is one of the key issues to be discussed below.

Data Integrity Issues

Most of the paper, consisting of four large tables occupying most of a printed page each, is a presentation of dosage statistics of the Australian population, which, while not irrelevant, are not germane to the main subject of the paper.

The space could be better used. The main subject and conclusion of the paper depend critically on analysis of the data relating dosage to COVID-19 and all-cause mortality shown in Figures 1 to 3.

These “death by vaccination status” data, central to the study, are largely absent from the paper. Importantly, the conclusion quoted above requires analysis of accurate Australian COVID data which are well-known to have serious integrity issues, which have errors originating from data collected from disparate sources and from flawed data recording procedures.

For example, someone who dies soon after being vaccinated with one dose may be recorded as the death of an unvaccinated person [2].

Also, COVID-19 mortality is intrinsically an unreliable statistic, because attribution of a COVID death may be erroneous. A death (ICD 10 code U07.1) could be with COVID (defined by a positive PCR test) rather than from COVID (the disease).

Sometimes, COVID deaths (ICD 10 code U07.2) have been assigned by judgement without doing any tests.

Raw COVID-19 mortality data by dosage, essential to the paper have not been disclosed in the paper, even in a summary form. How did they select and validate COVID-19 mortality data? The authors need to discuss the data of Figure 1 and 2 and should publish their compilation of the raw data, so that readers can replicate the results of their paper.

A further deficiency is: that measuring vaccination effectiveness (VE) by survival rates against only COVID-19 mortality is inadequate because it assumes falsely that vaccination does not have lethal side effects. Even the Therapeutic Goods Administration (TGA) has admitted [3] that there were 14 COVID vaccine-induced deaths to March 2023.

With mass vaccination, non-COVID excess deaths have reached about double COVID-19 deaths [4], which should be investigated for association with vaccination. Yet, with only a brief discussion suggesting how vaccination may reduce all-cause mortality, the authors have inserted “all-cause mortality” in the title of the paper, insinuating vaccination is also effective against all-cause mortality.

Method And Analysis Issues

Even ignoring data integrity issues, ignoring non-COVID excess deaths and supposing VE is validly measured against only COVID-19 mortality, the paper still suffers seriously from methodological and analytical defects. Vaccination, COVID-19 mortality and all-cause mortality data are available since 2021 and well into 2023.

Why does the paper select and analyze only eleven months of 2022? There were surges in deaths in 2022 accompanying the rollouts of the first and second boosters, but the paper does not consider that they may be related to vaccinations, rather than only to the COVID disease.

Instead of analyzing 2022 data as a whole, COVID and all-cause mortality data are analyzed in two separate periods: one five-month period and one six-month period. For different dose groups, vaccine effectiveness (VE) is evaluated by COVID-19 survival effectiveness for three windows: less than three months, three to six months and more than six months.

Such divisions of time periods need to be discussed, because analyzing survival over multiple fixed time periods involves unstated assumptions about the time taken for vaccines to have their effects, and the delay effects should be discussed.

The risk of errors increased due to survivorship bias, where deaths may “fall between the cracks” between survival windows. With two data periods, three dosage groups and three survival windows, there are 18 different vaccine mortality rates to compare to two unvaccinated mortality rates.

As may be expected, there are 18 different VE measures with a wide range of results depending on the various combinations. Importantly, the results appear random with no consistent VE pattern across the two time periods or between the dose groups.

In their main findings, the best and most convenient cases were selected for reporting. For example, from Figure 1 in the first period, the main finding reported was “VE of a 3rd COVID-19 vaccine dose within 3 months was 93 percent (95 percent CI 93–94 percent) whilst VE of a 2nd dose >6 months since receipt was 34 percent (26–42 percent)

Among unfavourable findings (see below), the most favourable finding has been cited by the authors to show COVID-19 vaccination is highly effective, but only relatively and “wanes with time”. Some of those unfavourable findings are masked by what appear as glaring anomalies, probably serious errors collected in table below.

From Figure 1 of the paper, the “Dose3>180 days” group has higher mortality rate (per 100 person-year) than the unvaccinated, yet they have positive vaccine effectiveness of 63.4 percent (COVID-19 VE (percentage) column below).

This and few other examples are shown in the table below, where a “Relative Risk Reduction (percentage)” column (should be the same as COVID-19 VE (percentage)) has been added here with shaded cells, simply calculated from the mortality rates given.

In the June to November period of Figure 1, the “Dose2 8-90 days” group had 1.218 mortality rate per 100 PY, compared to 0.49 for the unvaccinated. This shows that even in the short-term of less than three months, that vaccinated group (second shaded cell from the bottom) had 2.5 times higher risk of dying from COVID than the unvaccinated.

How could the authors claim for that case (second last column in the above table) a positive VE of 13.9 percent in their paper?

The paper needs to disclose the sorts of adjustments used to achieve positive “COVID-19 VE (percentage)” for those cases where the vaccinated groups had higher mortality rates than the unvaccinated. Those negative relative risk reduction results calculated here for those cases, if unexplained, would invalidate the main conclusion of paper that COVID-19 vaccination is highly effective.

Similar criticisms can be raised against the analysis in Figure 2 and Figure 3, where the method of adjustment for obtaining VE results for all-cause mortality is also not transparent, even though the raw all-cause data would be more accurate than COVID-19 data for reasons explained and discussed above.

On all-cause mortality the authors made unsubstantiated comments such as “COVID-19 vaccines also appeared effective against other specific causes of death…those who are more likely to get multiple vaccine doses, or to be vaccinated earlier are healthier and less likely to die from any cause…”. Emphasis added.

On Pfizer/BioNTech’s COMIRNATY vaccines alone, the TGA’s DAEN database [5] recorded (subject to underreporting) over 82,000 adverse events associated with many different diseases. Moreover, those comments are contradicted by the authors’ own analysis.

Figure 3 of the paper shows clearly that the authors’ own calculated VE against all-cause mortality (rates not shown) are all negative for those cases shown in the above table (last column).

Therefore, COVID-19 vaccination was ineffective and had increased all-cause mortality among some groups of older adults. Their evidence of ineffectiveness is consistent with Australian macro-data where all-cause mortality have increased significantly for older Australians vaccinated since 2021 [4].

Summary Of Critique

The approach of this study depends on official COVID data which have integrity issues, which the paper does not acknowledge.

Only 11 months in 2022 of official data out of possibly more than 24 months have been selected for the study.

The “death by vaccination status” data which link dosages with mortality data have not been discussed or disclosed. The key data used need to be publicly available for replication of the findings.

The unseen key data collection has been selectively analyzed, by dividing into separate time periods, dose groups and survival durations, producing 18 comparisons. The method of analysis is unsound and has led apparently to random results, without identifiable regularity.

The vaccination effectiveness results were not simply calculated, but adjusted. The details of the adjustments need to be disclosed.

The unadjusted results contradict the general conclusion that “COVID-19 vaccination is highly effective against COVID-19 mortality among older adults”.

Out of 18 comparisons of adjusted results, the most favourable and convenient findings have been selected and presented to draw the main conclusion which is not generally valid.

Conclusion

As it stands, the paper has serious deficiencies in data integrity, data selection bias, flawed methods of analysis, undisclosed adjustments of results, selective reporting of findings and the drawing of invalid conclusions.

The Australian Government has chosen to take this paper as authoritative evidence to justify its health policy, which has been associated with many excess deaths particularly in older Australians, but those deaths have been brushed off without investigation as coincidental, unrelated to vaccination.

The paper, in its currently published form, has serious methodological and analytical defects, resulting in errors and misleading conclusions.

Therefore, the paper needs substantial revision to address the issues raised or it should be retracted.

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22 November, 2023

Study Reveals Most Common Chronic Symptoms After COVID-19 Vaccination

A new study shows some of the most common chronic symptoms among people who began experiencing the problems after receiving a COVID-19 vaccine.

The most common symptoms were exercise intolerance, excessive fatigue, numbness, brain fog, and neuropathy, researchers reported in the paper.

Insomnia, palpitations, myalgia, tinnitus, headache, burning sensations, and dizziness were also experienced by at least half of the participants in the study, which was funded in part by the U.S. National Institutes of Health (NIH).

Participants reported a median of 22 symptoms, with a ceiling of 35.

The study focused on people "who report a severe, debilitating chronic condition following COVID-19 vaccination" that "began soon after COVID-19 vaccination and persisted in many people for a year or more," the researchers said.

The study was led by Dr. Harlan Krumholz of the Department of Internal Medicine at the Yale School of Medicine and Yilun Wu of the Yale School of Public Health's Department of Biostatistics.

It was published on Nov. 10 as a preprint ahead of peer review.

Methods

The paper comes from Yale's Listen to Immune, Symptom and Treatment Experiences Now (LISTEN) research, which examines both so-called long COVID and post-vaccine adverse events.
Researchers began recruiting participants in May 2022. Participants filled out a survey, and researchers had access to their health records.

The study featured adults who reported post-vaccination problems from May 2022 through July 2023. The 388 people who also reported so-called long COVID, or lingering symptoms after COVID-19 infection, were excluded. Another 146 people who didn't completely fill out the survey were also ultimately left out.

The median age of the participants was 46, and 80 percent were female. Approximately 88 percent live in the United States.

The design of the study means no causality could be confirmed, the researchers said. While they acknowledged the chronic symptoms could be caused by the vaccines, they alleged they could also be unrelated and have occurred by change, but also said the clustering of symptoms soon after vaccination "suggests a potential relationship."

Known side effects of the vaccines include heart inflammation, severe allergic shock, and Guillain-Barré Syndrome.

Other issues have been linked to the vaccines by some but aren't recognized as widely as confirmed side effects.

The symptoms could be quite painful. Participants reported a median of 80 on a scale of 100 when asked how bad their symptoms were on their worst days.

Lingering Symptoms

In the week before completing the survey, 93 percent of participants said they felt unease at least once.
More than eight out of 10 reported feeling fearful, and 81 percent reported feeling overwhelmed by worries.

Feelings of helplessness, depression, hopelessness, and worthlessness were also commonly reported.

Nearly the entire group said they felt rundown and 91 percent said they suffer from sleep problems.

On the other hand, half of participants reported being in good, very good, or excellent condition. Still, the rest reported fair, poor, or unknown status.

The symptoms started for many people soon after vaccination. The median time of symptom onset was three days. Seventy-seven percent of people experienced the symptoms after their first or second shot.

The study followed an NIH-authored paper that detailed 23 people who experienced persistent symptoms following COVID-19 vaccination.

A number of participants in the new study received new diagnoses after receiving a vaccine, including anxiety, neurological conditions, gastrointestinal issues, and postural orthostatic tachycardia syndrome.

Problems Before the Pandemic

Nearly half the participants had allergies before the pandemic, according to the study. About three quarters of the participants in total had at least one comorbidity, such as allergies.

Behind allergies, the most common comorbidities were gastrointestinal issues, with acid reflux as an example; anxiety disorders; depressive disorders; and asthma.

Arthritis, an autoimmune disease, high cholesterol, hypertension of high blood pressure, and migraines were also reported each by more than two dozen people.

Treatments Tried

Many participants tried multiple treatments for their symptoms. Nearly all tried probiotics, which help boost good bacteria in the body.

Vitamins and supplements were also frequently turned to, with vitamins b12, c, and d and ibuprofen being the most popular.

Anti-inflammatory drugs, including ibuprofen, were used by a majority of participants.

Oral steroids such as dexamethasone were used by about half of the group.

Lifestyle changes were also common, with 51 percent limiting exercise or exertion, 44 percent cutting alcohol or caffeine, and 44 percent increasing or decreasing how much salt they consumed. Another approximately four in 10 changed their diet.

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U.S. Army Begs Soldiers to Come Back After They Were Forced Out for Not Getting the COVID Vaccine

Soldiers who were forced out of the U.S. Army because they refused to follow the Biden Administration’s draconian COVID-19 mandates are being asked to come back as a potential war looms.

This week, the United States Army sent letters to service members inviting them back to their branch despite being ousted over their refusal to get the COVID-19 vaccine.

In February, the U.S. Army rescinded its order requiring service members to be vaccinated in order to fight for their country.

The letter reads:

Dear Former Service Member, We write to notify you of new Army guidance regarding the correction of military records for former members of the Army following rescission of the COVID-19 vaccination requirement. As a result of the rescission of all current COVID-19 vaccination requirements, former Soldiers who were involuntarily separated for refusal to receive the COVID-19 vaccination may request a correction of their military records from either or both the Army Discharge Review Board (ADRB) or the Army Board for Correction of Military Records (ABCMR). Individuals may request a correction to military personnel records, including records regarding the characterization of discharge. Individuals who desire to apply to return to service should contact their local Army, U.S. Army Reserve (USAR), or Army National Guard (ARNG) recruiter for more information.

At the height of the Left’s COVID hysteria, the Biden Administration claimed that unvaccinated soldiers “present risk to the force and jeopardize readiness.”

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More Than Half Of Vaccinated People Feel Ill A Year Later

Why to do many people feel sick nowadays? A recent study from India suggests the COVID-19 vaccine is causing prolonged symptoms in over half of unwary recipients

Shrestha and Venkataraman published a study of data collected from September 2021 and May 2023, in a descriptive, follow-up cohort study that was conducted, having enrolled participants who were 18 years of age or older, met the vaccination requirements established by the Ministry of Health and Family Welfare, Government of India, and had completed the primary immunization series with the AZD1222Ž (adenoviral) or BBV152Ž (whole-virion inactivated vaccine).

The prevalence of post coronavirus vaccine syndrome (PCVS) and the QoL measured using EQ-5D-5L were assessed at one month, six months, and 12 months post-COVID-19 vaccination.

The authors found more than half of subjects at 12 months were reporting symptoms of PCVS.

These data fit what I am seeing in clinical practice.

This study provides a strong rationale for most vaccinated individuals to undergo McCullough Protocol Base Spike Detoxification for 3-12 months with:

-Nattokinase 2000 FU (100) bid

-Bromelain 500 qd

-Curcumin 500 mg bid (nano, liposomal, or with piperine)

These are starting doses which can be increased if well tolerated.

No therapeutic claims can be made since there are no large, prospective, randomized double-blind clinical trials completed.

Unfortunately, no such trials are planned or registered at this point in time.

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21 November, 2023

Long Covid is a vaxx injury

The ‘midwit’ really came into their own during Covid and what a curse on the world they all were, these individuals of above average intelligence, but not too far above, who nevertheless liked to think of themselves as far wiser than the common pleb. Every state Chief Medical/Health Officer in Australia was, in my opinion, a classic midwit, diving into complex, multi-faceted public health issues with simplistic notions and infantile policies.

The CHOs/CMOs appeared to be entirely unaware of the limits to their public health omniscience, but their omnipotence was, alas, very real. They could issue legally enforceable, but patently absurd, Public Health Orders of great scope. Cheered on by media flattery, they went about stuffing up entire economies and ruining or degrading many people’s lives with bull-in-a-china-shop effectiveness.

Most of the Covid midwits have receded into the intellectual swamp they came from because no one is listening to them anymore. In America, for example, only 2 per cent of the population have availed themselves of the latest ‘bivalent’ booster that is supposed to protect against two new horror strains. In Australia, a mere 8.1 per cent of Australians aged 18-64 were ‘fully immunised’ at September 27 and less than half (44.3 per cent) of people aged 75+ (those allegedly most vulnerable to the Worst Disease Ever) have bothered to seek out the recommended up-to-date jab. We are over it.

Some Covid midwits, however, are still valiantly fighting a rearguard action. They are like that Japanese soldier, second-lieutenant Hiroo Onoda, who did not surrender and who hung out as a guerrilla fighter for 29 years in the Philippines after the end of the war in the Pacific. He must have been an inspiration for Australia’s own ‘Never Surrender’ Covid warriors who are manning the ‘Long Covid’ redoubts, masks in hand and boosters at the ready. These include some doctors who staff Australia’s 80-odd ‘Long Covid’ clinics where the lost war against Covid is still being fought.

An enthusiast from one of these clinics recently took to the trenches of social media to come to the aid of the Canadian branch of the Ever-Covid Resistance, one of whose fighters had complained of having twice ‘gotten Covid’ in the last month. Their Downunder ‘Long Covid’ clinic comrade, and fellow Covid magnet, agreed that recurring Covid infections are real and how three times in a year, in March, June and August of 2022, they had contracted Covid despite being ‘fully-immunised’ with each infection as grim as the last.

It seems that all their friends are getting Covid about every five weeks, leading them to conclude that it is now possible to be infected, not just frequently, but even by more than one Covid variant at the same time. Covid doesn’t even wait for the last infection to end anymore. That’s one dangerous viral enemy out there!

It had to be Covid that was responsible because, like Caesar’s wife, the Covid vaccine remains above suspicion. The possibility that, booster by booster, people have been trashing their immune systems in addition to picking up a host of other vaccine injuries, is not considered. One Australian Long Covid champion alleges the following gems on social media:

100 per cent of the clinic’s ‘Long Covid’ patients have microclots in their blood (nothing else could be causing that, doctor?).

Covid increases your risk of heart attacks, strokes, and clots (see above).

Covid can persist in tonsils, the brain, the lymph nodes, the heart, generally anywhere.

‘Generally anywhere’! This pretty much sums up what happens when a toxic spike protein travels throughout the body, courtesy of the blood vessels, and transfects millions of cells through the LNP cell-penetrating delivery system (whilst a respiratory virus stays put in just the respiratory system – the clue is in the name).

19 per cent of Long Covid patients have myocarditis. (Which other group of the population is getting myocarditis which used to be quite rare until something new and toxic came on the scene?)

The clinic’s patients include 14-year-olds who present with fast heart rate and chest pain, contributing to ‘mass disablement – especially of young people’. (Seek Covid and ye shall find Covid; do not seek vaccine injury and ye shall not find vaccine injury…)

It is further claimed by some doctors that unjabbed people are also getting Covid all the time but they just don’t know it because they aren’t testing for it! How will anyone know they are sick with Covid if they don’t test for it? They probably think they are perfectly fine, or have a common cold or something… Those complacent fools! ‘So, please stop saying Long Covid is just a cold when it really, really isn’t!’ Or so they insist. Well, that is kind of correct. What would have been ‘just a cold’ for almost everyone may have been turned into something far, far worse following vaccination.

Online defences of ‘Long Covid’ are notable for what they don’t say. By now, it appears that even medical midwits are losing faith in the vaccine. As some lament, despite their repeated grim infections they have stopped mumbling the once-routine phrase, ‘Thank goodness I was fully vaccinated because otherwise it would have been so much worse!’ Indeed, that flimsy last line of vaccine defence has faded from the entire narrative except at government headquarters where it still gets an increasingly desultory run as the sole remaining virtue of the dud vaccines.

Even though the top generals of the Covid war effort have shown cowardice in the face of the viral enemy, according to the remaining midwits (who are particularly cross about the World Health Organisation ending the formal ‘global health emergency’) there is still a war to be won because ‘someone is dying every three minutes [from Covid] and 10 per cent of all those infected will get Long Covid’.

All is not lost! For the midwits, there is still The Mask, that insignia of the Covid midwit army. The Mask represents midwittery at its most moronic.

The media allies of the Covid Midwits are lending vital auxiliary support in the never-ending defence of Covid hysteria. In South Australia, there is another dogged pocket of resistance to Covid sanity – ‘South Australians suffering debilitating symptoms from Long Covid are being forced to wait up to ten months to see experts in one of the state’s Long Covid Assessment Clinics at the Royal Adelaide Hospital’, reports InDaily.

‘Long Covid’ is the new virus ogre in town these days, superseding the now frankly toothless and boring old ordinary Covid ‘case’ count. Despite the odd article emerging to scare us about ‘cases’ (which ‘continue to plague the state with weekly reported cases of 645’) this sort of dodgy statistic doesn’t turn a hair these days (remember when we shut the state down for a handful of ‘cases’?). Now it’s the turn of ‘Long Covid’ and its myriad discontents.

Covid of the ‘Long’ variety can leave you wiped out for months or years on end and everyone who gets Covid is potentially at risk of Long Covid. ‘SA Health estimated 35,000 South Australians can expect to contract long Covid’. Cue the alarm bells because the Covid astrologers have spoken. Mind you, it may be yet more worthless Covid modelling but, despite that, it gives us some sort of bargain basement government estimate for the number of serious Covid vaccine injuries to come but no alarm bells will be rung for that and no Long Vaxx clinics will ever be established.

Demand for the ‘Long Covid’ clinics in South Australia is already through the roof from people who, for more than 12 weeks, have been experiencing ‘complex symptoms and significant functional impairment, with symptoms ranging from severe fatigue to brain fog and breathlessness’, drastically ‘impacting their return to work, study or social roles’. The clinics have been forced to triage the wave of patients so that those with the most severe symptoms are seen first, leaving those with less chronic symptoms waiting for nearly a year to be seen.

I think, in retrospect, what the Long Covid midwits are fretting about isn’t just a cold, or even post-viral syndrome (which is possible after any viral infection), but vaccine injury. The harms of the Covid vaccine are being swept under the rug of ‘Long Covid’. Long Covid is Long Vaxx Injury. It really really is.

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NY Times says school COVID closures may be ‘most damaging disruption’ to kids’ education in U.S. history

The New York Times editorial board penned a new editorial on Saturday stating that the school closures enacted in response to the COVID-19 pandemic "may prove to be the most damaging disruption in the history of American education."

The editorial provided a reflection on the "significant" learning losses stemming from keeping around 50 million kids out of the classroom because of the virus, and urged elected officials and the education community to move quickly to heal some of the damage.

The paper came to these points after certain mainstream media outlets supported these same closures. Some media figures have continued arguing they were good decisions.

The editorial opened with a dire assessment of what COVID-19 closures did to America’s schoolchildren. It stated, "The evidence is now in, and it is startling. The school closures that took 50 million children out of classrooms at the start of the pandemic may prove to be the most damaging disruption in the history of American education."

"It also set student progress in math and reading back by two decades and widened the achievement gap that separates poor and wealthy children," it added.

To compound the issue, the board noted that learning losses "will remain unaddressed when the federal money runs out in 2024."

As such, this generation of students "will experience diminished lifetime earnings and become a significant drag on the economy," The Times added, citing economists.

The editorial lamented that school administrators and politicians are not mobilizing the country to meet this issue, noting that combating it requires a "multidisciplinary approach," starting with "getting kids back on solid ground," and replacing "the federal aid that is set to expire."

It also detailed how an "epidemic of absenteeism" is compounding the challenge of rehabilitating these students.

The board wrote, "students who grew accustomed to missing school during the pandemic continue to do so after the resumption of in-person classes. Millions of young people have joined the ranks of the chronically absent — those who miss 10 percent or more of the days in the school year — and for whom absenteeism will translate into gaps in learning."

The piece also mentioned how these kids are "also vulnerable to mental health difficulties that worsened during the pandemic."

Citing the CDC, the Times said, "more than 40 percent of high school students had persistent feelings of sadness and hopelessness; 22 percent had seriously considered suicide; 10 percent reported that they had attempted suicide."

The editorial concluded, "The learning loss crisis is more consequential than many elected officials have yet acknowledged. A collective sense of urgency by all Americans will be required to avert its most devastating effects on the nation’s children."

Despite its current concern over the closures’ harm to American students, New York Times reporting in 2020 advocated for school closures despite the risks.

In a March 2020 piece, the Times wrote, "More and more schools have chosen to close in the past few days, reflecting a growing consensus that the benefits of closings outweigh the harms, especially since many of the harms can be mitigated."

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20 November, 2023

Covid lockdowns were NO more effective than Swedish-style softer approach, major Oxford University-backed study suggests

Covid lockdowns were no more effective at controlling the pandemic than letting people adapt their own behaviour to the threat, a major Oxford University-backed study suggests.

Researchers modelled virus death and unemployment rates in response to different pandemic policies.

Results showed imposing blanket shutdowns, which forced people to stay home and closed essential shops, squashed fatality rates for the virus.

However, leaving people to adapt their own behaviour — similar to the controversial approach used in Sweden — was just as effective, data revealed.

Experts concluded that both policies led to 'similar trade-offs' for people's health and the economy, with both approaches triggering huge job losses.

The researchers said strict non-pharmaceutical interventions (NPIs) — lockdowns, social distancing and face masks — were 'critical' to reducing the spread of Covid.

However, they noted that individuals changing their behaviour of their own accord — such as by minimising contacts and less frequent trips to shops or restaurants — could have also minimised deaths.

To determine the effects of both approaches, the researchers created an economic model based on the first wave of the pandemic.

They used data from around 416,000 people in New York City.

Researchers inputted a range of scenarios, including varying levels of restrictions and changes to behaviour.

The model then estimated how many infections occurred as a result, as well as which occupation, income and age group were most affected.

Results, published in the Nature Human Behaviour Journal, showed that both strict lockdowns and high rates of behaviour change led to a rise in unemployment and fewer Covid deaths.

For example, if lockdowns were imposed, virus deaths fell 35 per cent while unemployment jumped 64 per cent.

In comparison, if people were left to their own devices in a 'high fear' situation, deaths fell 50 per cent, while job losses increased by 40 per cent.

The team said this showed there is a 'similar trade-off between epidemic and economic outcomes' regardless of whether Covid restrictions are imposed or if people are left to change their behaviour.

'Both substantial behavioural changes and stringent closures lead to similar patterns of rising unemployment and fewer infections,' they wrote.

The researchers found that this trend still stands, even if older people make bigger changes to their behaviour than younger people.

'While it is intuitive to expect stricter mandated NPIs to increase unemployment and decrease Covid-19 deaths, it is less apparent that heightened behavioural adaptation would yield similar results,' the team added.

They also found that forcing the closure of sectors that aren't people-facing — such as construction and manufacturing — triggers a large spike in job losses with 'only a marginal decrease in fatalities'.

Additionally, bringing in pandemic restrictions late when people have already adapted their behaviour 'leads to a dual blow of increased deaths and unemployment'.

The researchers noted that their results are only based on data from one area of the US during the first lockdown and do not take testing, Covid variants or vaccination into account.

However, the findings address 'key policy debates' of the Covid pandemic and will enable future governments take tough decisions, they said.

Professor Doyne Farmer, director of the complexity economics programme at Oxford University's Institute of New Economic Thinking, said the paper is 'timely' given the ongoing Covid inquiries around the world.

He said: 'We are seeing governments across the globe begin their "moments of reckoning", reviewing the effectiveness of a great variety of policies brought in during Covid.

'According to some, lockdowns were not imposing any trade-off between health and the economy because, if the virus got out of control, the economy would be equally damaged.

'According to others, letting at-risk individuals spontaneously reduce their risk of infection would have led to the best epidemic and economic outcomes, with no trade-off.

'These debates have remained contested and unresolved.'

Professor Farmer said: 'Our quantitative research helps provide evidence-based answers to these questions, suggesting that both lockdowns and spontaneous behaviour change lead to similar trade-offs between health and the economy.

'Those that claimed that there was no trade-off between health and the economy were not basing their belief in a quantitative model.'

The UK imposed its first lockdown in March 2020, with then Prime Minister Boris Johnson telling the nation 'you must stay at home'.

It saw schools, shops and hospitality close, social distancing come into force and Brits only allowed to exercise outdoors once a day.

Experts largely accepted that the economically-crippling measures were vital to control the spread of the virus, as there was no vaccine to prevent severe illness and stunt hospital admissions at the time.

But other epidemiologists and public health scientists shared 'grave concerns' about the collateral damages of such policies on the NHS and other parts of society in future.

Sweden became an international outlier in 2020 when, instead of shutting down society, it relied on citizens' sense of civic duty to reduce the spread of Covid.

Authorities advised residents to practice social distancing, however schools, bars and restaurants remained open and it never required people to wear masks — they were only recommended on public transport during the second wave.

Among its stricter measures included a ban on visits to elderly care homes and limits on the number of people attending public gatherings.

The approach gave rise to a heated debate abroad, and was at times held up as a cautionary tale, or on the contrary, hailed by opponents of lockdowns.

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Top doctor Nick Coatsworth delivers a brutal reality check for Aussies who still wear face masks

One of Australia's top doctors has issued a brutal message to those still wearing face masks - and hit out calls from the Australian Medical Association to bring back Covid masks.

Australia reported 6,550 new Covid cases last week. This surge has led health officials, including AMA Queensland president Maria Boulton, to advocate for the reinstatement of mask mandates in high-risk settings, such as on airplanes, in large crowds, and within medical facilities.

However, former Australian deputy chief health officer Dr Nick Coatsworth said Aussies shouldn't be overly concerned about the recent spike during an interview with 2GB'S Ben Fordham.

'The Australian Medical Association has quoted 245 hospitalisations of COVID-19 with this (current) wave in Queensland, but there are over a million admissions to Queensland hospitals every year,' he said. 'The suggestion that this is a wave is probably incorrect.'

He also believes reinstating mask mandates would have little impact. 'That's not going to make any difference at the moment,' Dr Coatsworth explained.

'If you say 'Look, wear masks in some situations but not others, don't socially distance and go about your business', then all the masks are doing is polluting the environment.' 'We need to be smarter about how we manage this.

He also slammed advice from scientists recommending 100,000 concertgoers to mask up when Coldplay performs in Perth this weekend. 'That's just a crazy thing to do,' he said.

'We got to remember just how infectious Omicron is. Just sticking a mask on at a Coldplay concert is unlikely to be protective.

'And number two, the vast majority of people have had Covid, even the people who claim they've never had it. The vast majority of people are also vaccinated.

'COVID-19 is now a milder disease because of what we call herd immunity, we have all been exposed to it. 'Our need to take a chill pill with Covid is getting even greater.'

Dr Coastworth isn't overly concerned about the latest spike but conceded it puts a strain on hospitals. 'The reason why health departments have put this out is because when we do get an increase in Covid or any respiratory virus, it does puts a strain on hospitals,' he said.

'I work in an hospital and you do see the strain but not because people are getting sick from Covid. 'Very few people are actually getting sick from Covid but it creates an infection control problem where you have to isolate the patients and it created bed pressure.

'But that's going to happen for the next 5-10 years with Covid and respiratory viruses and we have to find ways to cope with that.

'Frankly I was on shift yesterday and we had not a single patient with COVID-19 in our acute medical unit.

Dr Coatsworth emphasised that despite a minor increase in hospitalisations, there has been a decline in intensive care admissions from Covid.

'There's creative, innovative ways that will allow the community to get on with its business without constant talk of bringing back things that realistically, public health officials aren't going to bring back.'

Dr Coatsworth echoed the health advice to catch up outdoors where the risk of getting Covid is 'extraordinary difficult, if not impossible.' 'It's always been the right advice, I'm not sure why we didn't give it at the start of the pandemic,' he said. 'You would really have to be on top of someone to catch Covid outdoors.'

Meanwhile, infectious diseases specialist Professor Peter Collignon has made it clear he opposes people being forced by law to wear masks. 'If at increased risk, or concerned, yes wear a mask. But no mandates.'

Professor Collignon, who is a microbiologist at Canberra Hospital, said there was 'little or likely no point' wearing a mask outside.

He added that masks will give 'some short term protection' to those who are concerned about short term exposure indoors, but eye protection is also needed. 'What lands in your eyes goes into your nose,' the professor said.

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19 November, 2023

No More COVID-19 Shots for Youth? A Bigger Politicization Agenda Behind COVID-19

“The real Covid jab scandal is finally emerging." A November 9 comment in The Telegraph provides a good introduction to the topic of why, when they faced little risk, we vaccinated kids for COVID-19. The conclusion is in the article’s subtitle: “The young and healthy, who were at minimal risk from Covid, should not have been told they had to take the vaccine.”

We learn that one Lisa Shaw, an award-winning BBC presenter, had her first COVID-19 vaccination on April 29, 2021. This 44-year-old mom thought she was doing her part to keep others safe. Within days, Shaw “developed a headache and stabbing pains behind her eyes which wouldn’t go away.” And by May 16, she was in hospital with blood clots in the brain. She could hardly speak, and a portion of her skull was removed to relieve pressure. Then, on May 21, Ms. Shaw died; the coroner found the death was due to the AstraZeneca COVID-19 vaccine.

“Ms. Shaw was previously fit and well,” yet it was “clearly established” that she died from a rare “vaccine-induced thrombotic thrombocytopenia (VITT).” VITT is “a new condition which leads to swelling and bleeding of the brain.”

Back in 2021, UK Health Secretary Matt Hancock, as part of “strenuous efforts” to ease the public’s concerns, had said the AstraZeneca product was “a great British success story.” Prime Minister Boris Johnson even tweeted that, “It is truly fantastic news – and a triumph for British science….” Fast forward to yesterday, and TrialSite reported on a large lawsuit against that same vaccine in the UK maker—the plaintiff: the VITT Litigation Group.

“Severe brain injury”

Our next perspective comes from the BBC, also on November 9, “AstraZeneca faces legal challenge over Covid vaccine.” They note that the father of two, Jamie Scott, received his jab in April 2021, and that he thereby “suffered severe brain injury.” His case is being brought under the Consumer Protection Act and alleges that the product is “defective” in that it was more dangerous than folks were led to believe. Another 80 vaccine victims are due to launch a suit later in 2023. All are involved with the aforementioned VITT Litigation Group.

According to AstraZeneca, "Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines---Our sympathy goes out to anyone who has lost loved ones or reported health problems--From the body of evidence in clinical trials and real-world data, Vaxzevria [the vaccine against Covid] has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects."

“Vaccine-induced immune thrombosis and thrombocytopenia”
Many victims have obtained one-time Ł120,000 payments via the UK’s Vaccine Damage Payment Scheme. FOIA requests show that of 148 VDPS recipients, 144 had received that AstraZeneca product.

Scott’s wife Kate has told BBC, "Jamie has had over 250 rehabilitation sessions from specialists, he had to learn to walk again, to swallow, to talk. [He has had] memory problems---Although he has done very well with them, we are at the point now where this new version of Jamie… is the version that will go forward. He has cognition problems…he has aphasia. Severe headaches, blindness---We need the government to reform the vaccine damage payment scheme. It is inefficient and unfair…and then fair compensation." Within months of the AZ rollout, cases of post-vaccination blood clots began to arise. And the aforementioned “vaccine-induced immune thrombosis and thrombocytopenia (VITT) was eventually identified.”

Ironically, BBC is a target of a lawsuit TrialSite is participating in---a a key member of the Trusted News Initiative or “TNI.”

This media cabal consisting of top media and tech companies collaborated to ensure that critical message of the type TrialSite was reporting on was blocked from the public.

After presidential candidate Kennedy called TrialSite founder Daniel O’Connor to discuss the potential lawsuit, TrialSite joined to support what has been both censorship and a potential platform to destroy competition.

So, while the BBC has the green light to report on vaccine injuries now, back in early 2021, when TrialSite was one of the only media reporting on such events. They and the mainstream media followed national emergency scripts, chucking real journalism. So did the pharmaceutical trade press, TrialSite’s more direct competition. Not a peep to this day from the like about some of the more insidious externalities associated with COVID-19.

TrialSite reported on many of the front-line physicians who argued that the vast majority of COVID-19 cases were mild to moderate, especially among young people. This more independent, critical group of providers argued against the need for COVID-19 vaccination.

Put another way, the risks of vaccination outweighed the benefits, according to this cohort. The mainstream argument cited the surge in child hospitalization during Delta and the emergence of MIS-C as a reason for vaccination. Yet opinion contributors such as Geert Vanden Bossche have argued that this never justified mass vaccination of our youngest members of society.

TrialSite has repeatedly reported to the market that, to this day, the Food and Drug Administration (FDA) cannot verify the safety of Pfizer’s Comirnaty to the American public for both children and pregnant women.

Section 8.1 of the FDA packaged insert involving pregnancy:

“Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.” Section 8.4 for young children 12 and under states, “The safety and effectiveness of COMIRNATY in individuals younger than 12 years of age have not been established.”

Why are U.S. health authorities still pushing this vaccine on society’s most vulnerable people other than the elderly with no emergency, a case fatality rate at a level of influenza or even lower, and seemingly overwhelmingly mild to moderate upper respiratory infections, given the reports of side effects and no ability to verify the safety on the label?

WHO deprioritizes youth vaccination

Some nations are starting to get it, including the collection of health representatives that is the World Health Organization (WHO). On March 29, 2023, CNN offered another look at the subject of COVID-19 vaccines for youth, “WHO experts revise COVID-19 vaccine advice, say healthy kids and teens low risk.” They note that “The World Health Organization’s vaccine experts have revised their global COVID-19 vaccination recommendations, and healthy kids and teenagers considered low priority may not need to get a shot.”

This updated “roadmap” aims to “prioritize COVID-19 vaccines for those at greatest risk of death and severe disease, according to the World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE).” A SAGE press release offered that “The public health impact of vaccinating healthy children and adolescents is comparatively much lower than the established benefits of traditional essential vaccines for children – such as the rotavirus, measles, and pneumococcal conjugate vaccines.”

TrialSite reported on prestigious academic medical centers such as Murdoch Children’s Research Institute, which have studied the matter and all but concluded the push for COVID-19 vaccines should be used for the more traditional vaccine schedule now, given declining rates due to heightened hesitancy.

At the core of the problem is that the current COVID-19 vaccines’ efficacy and risk mix just don’t compel objective pediatric care and research inquiry.

Science and medicine have been completely politicized during the pandemic. We will not go back to a more sane and rational time when the professionals respected their respective lanes.

The Biden Administration’s mandates (some of which were ruled unconstitutional) were announced in 2021, when we already knew the COVID-19 vaccines failed to stop viral transmission and were associated with some dangerous side effects, albeit relatively rare. It doesn’t matter, given the ever-milder strains involving Omicron. Of course, there were still outlier severe cases, and the elderly continued to face higher risk.

This author suggests the Biden move was, behind the scenes, a power play meant to reign in on an emerging medical freedom movement that was identified by the Washington power structure as aligned with MAGA and Trump. After all, even before the outrageous September 6 actions, tensions between opposing political viewpoints were boiling over. It seems American society hasn’t been so divided since perhaps the Vietnam War, maybe even since the Civil War. Social media and changing cultural dynamics fostered an environment of tribal division based on lifestyles and self-identified clicks.

The Biden Administration continues to exploit the pandemic, even if it's over—there is no more emergency—with at least $5 billion in taxpayer funding used so bureaucrats in Washington can pick winning vaccines and other medicinal countermeasures. It’s as if we are in a continuous emergency, or put another way, a new politicized reality.

This isn’t to deny that Trump also politicized the pandemic. He did so as well, first trying to deny its risk, acknowledged in the Woodward interviews. Operation Warp Speed became a somewhat corrupted free-for-all with billions of taxpayer dollars changing hands.

Ominous Roots

Of course, we here at TrialSite cannot be 100% certain, but this author puts forth with 90%+ confidence based on the evidence we have secured that SARS-CoV-2 emerged from the laboratory. We have government documentation that alleges it’s a homegrown (American) technology, and we speculate that it likely leaked inadvertently at the Wuhan Institute of Virology (WIV).

We cannot be certain, and there is some evidence that the pathogen emerged before the Wuhan outbreak on both sides of the Pacific Ocean.

This is why it has been so difficult to discover the origin of this particular coronavirus, while the others (SARS-CoV/MERS) were discovered. All sorts of questionable actions have occurred. Even during the second investigation by WHO into the SARS-CoV-2 origins, the president of EcoHealth Alliance (Peter Daszak) was chosen to represent American interests.

What? That’s the last person who should have traveled to Wuhan in early 2021. This smelled as part of a broader coverup. EcoHealth Alliance has been all but proven to be part of a scheme to outsource gain-of-function to China on behalf of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. See TrialSite’s early timeline and concerns about origin in “Origins of the Pandemic are Elusive & Timeline Reveals Glimpse into Path to Better Tomorrow.”

Remember all of the back and forth between Rand Paul and Fauci? What ever happened? Why has Sen. Ron Johnson sent dozens of letters inquiring into this or that in these bureaucracies with no response? Like so many other inquiries, they are made more for show for the specific tribal following than anything else.

We suspect a cover-up that includes both the Chinese government but also elements in the American government, as well as others, with intelligence agencies used to run cover and interference.

Why did the Missouri legal case uncover a rat’s nest of government intelligence operatives on Twitter?

Likely, a government operation was ordered to run the cover, help shape the narrative, and incite division and conflict. Some evidence emerged that some elements in the Central Intelligence Agency sought to buy out analysts who would express their real concerns about origins.

And, of course, Dr. Anthony Fauci served a key purpose, but he is just one of many who are part of the coverup, should we be correct. And few individuals likely have a comprehension of the whole story.

Again, based on our educated estimates, there’s a 10% chance we are off the mark, and all of this is something different. This has to be understood. I must convey that this is an opinion piece and not the formal stance of TrialSite Inc., a Delaware and Utah corporation that officially takes a far more conservative stance.

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16 November, 2023

Eye-Opening Video Banned From Social Media

A controversial video was taken down from sites almost as fast as people could upload it. Censored even from YouTube, it strikes at the heart of our government’s COVID-19 pandemic response team.

Late in May 2020, media producer Mikki Willis released the first part of his documentary “Plandemic,” featuring Judy Mikovits, who has a doctorate in biochemistry and molecular biology and is a cellular and molecular biologist1 whose research revealed many vaccines are contaminated with gammaretroviruses due to the viruses being grown in contaminated animal cell lines.

The 26-minute film was banned on every social media platform after going viral.2 On Aug. 18, 2020, Part 2, titled “Plandemic: Indoctornation,” was released.

Plandemic: Indoctornation

Part 2 is a full-length feature revealing a possible driving force behind the vaccine agenda. It looks at the roles of the World Health Organization (WHO), Bill Gates, Tedros Adhanom, Dr. Anthony Fauci, mainstream media, Silicon Valley tech giants, Big Pharma, and many others, connecting the dots between them.

Free supplemental footage, including a follow-up interview with Ms. Mikovits, as well as links to additional resources provided by all of the interviewees, is supposed to be available on the film’s website, PlandemicSeries.com.

Event 201

The film starts out by reviewing Event 201, a pandemic preparedness simulation hosted by the Johns Hopkins Center for Health Security, the World Economic Forum, and the Bill and Melinda Gates Foundation in October 2019—10 weeks before the COVID-19 outbreak first began in Wuhan.

This scripted tabletop exercise included everything we now see playing out in the real world, from PPE shortages, lockdowns, and removal of civil liberties to mandated vaccination campaigns, riots, economic turmoil, and the breakdown of social cohesion.

A highlight reel of the predictions put forth during this event is included in the documentary.

At the time, the leaders at Event 201 spent a great deal of time discussing ways to limit and counter the spread of expected “misinformation” about the pandemic and the vaccines that would have to be developed. In addition to outright censorship, their plan included the use of “soft power,” a term referring to stealth influencing using celebrities and other social media influencers.

CDC Owns Coronavirus Patents

Mr. Willis interviews David E. Martin, a national intelligence analyst and founder of IQ100 Index, which developed linguistic genomics, a platform capable of determining the intent of communications.

According to Mr. Martin, in 1999, IBM digitized 1 million U.S. patents, which allowed his company to conduct a review.

Using linguistic genomics technology, Mr. Martin made the “horrific assessment” that one-third of all patents filed in the United States were functional forgeries, meaning that “while they had linguistic variations, they covered the same subject matter.”

In 1999, patents for coronavirus also started to appear, “and thus began the rabbit trail,” he said.

In 2003, Asia experienced an outbreak of SARS. Almost immediately, scientists began racing to patent the virus. Ultimately, the CDC nabbed ownership of SARS-CoV (the virus responsible for SARS) isolated from humans.

The CDC actually owns the entire genetic content of that SARS virus. It’s patented under U.S. patent 7776521. It also owns patents for detection methods and for a kit to measure the virus.

U.S. patent 7279327,3 filed by the University of North Carolina at Chapel Hill, describes methods for producing recombinant coronaviruses.

Ralph Baric, who has a doctorate in microbiology and is a professor of microbiology and immunology, famous for his chimeric coronavirus research, is listed as one of the three inventors, along with Kristopher Curtis and Boyd Yount.

The law clearly states that genetic segments are ‘not patent eligible merely because it has been isolated.’

According to Mr. Martin, Dr. Fauci, Mr. Baric, and the CDC “are at the hub” of the COVID-19 story. “In 2002, coronaviruses were recognized as an exploitable mechanism for both good and ill,” Mr. Martin said, and “Between 2003 and 2017, they [Dr. Fauci, Mr. Baric, and the CDC] controlled 100 percent of the cash flow to build the empire around the industrial complex of coronavirus.”

CDC Has Broken The Law, One Way Or Another

Now, here’s the key take-home message Mr. Martin delivers. There’s a distinct problem with the CDC’s patent on SARS-CoV isolated from humans because, by law, naturally occurring DNA segments are prohibited from being patented.

The law clearly states that such segments are “not patent eligible merely because it has been isolated.” So either SARS-CoV was manmade, which would render the patent legal, or it’s natural, thus rendering the patent on it illegal.

However, if the virus was manufactured, then it was created in violation of biological weapons treaties and laws. This includes the Biological Weapons Anti-Terrorism Act of 1989, passed unanimously by both houses of Congress and signed into law by George Bush Sr., which states:4

“Whoever knowingly develops, produces, stockpiles, transfers, acquires, retains, or possesses any biological agent, toxin, or delivery system for use as a weapon, or knowingly assists a foreign state or any organization to do so, shall be fined under this title or imprisoned for life or any term of years, or both.

There is extraterritorial Federal jurisdiction over an offense under this section committed by or against a national of the United States.”

So as noted by Mr. Martin, regardless of which scenario turns out to be true, the CDC may have broken the law one way or another, either by violating biological weapons laws or by filing an illegal patent.

Dubiously, on May 14, 2007, the CDC filed a petition with the patent office to keep its coronavirus patent confidential.

Now, because the CDC owns the patent on SARS-CoV, it has control over who has the ability to make inquiries into the coronavirus, Mr. Martin noted. Unless authorized, you cannot look at the virus, and you cannot measure it or make tests for it since the CDC owns the entire genome and all the rest.

“By obtaining the patents that restrained anyone from using it, they had the means, the motive, and most of all, they had the monetary gain from turning coronavirus from a pathogen to a profit,” Mr. Martin said.

Dangerous Gain-Of-Function Research Was Permitted

Mr. Martin goes on to describe events occurring between 2012 and 2013. At that time, the National Institutes of Health (NIH) decided to take another look at gain-of-function research, ultimately deciding that gain-of-function research on coronavirus was too risky to continue.

This led to the suspension of funding for such research in 2013. That included funding flowing into Harvard, Emery, and the University of North Carolina–Chapel Hill. However, while the NIH had moral and even legal reasons for suspending such research, it made the funding pause voluntary, not mandatory.

Then, in 2014, when the push-back against gain-of-function research into coronaviruses grew further, the NIH—under the leadership of Dr. Fauci—offshored that research to—you guessed it—the Wuhan Institute of Virology in China.

However, as detailed by Mr. Martin, the funding was not sent in a straightforward way. Instead, it was funneled through front organizations such as the EcoHealth Alliance, led by its president, Peter Daszak, whose research, according to the EcoHealth Alliance website, “includes identifying the bat origin of SARS.”5

Between 2014 and 2019, EcoHealth Alliance received a long list of grants from the NIH to study “the risk of bat coronavirus emergence.” EcoHealth Alliance then subcontracted that work to the Wuhan Institute of Virology.

Therefore, in the end, the United States could deny culpability, blaming the outbreak on China when, in fact, it was American research that had been outsourced.

Interestingly, in late-breaking news on Aug. 19, 2020, The Wall Street Journal6 reported that the NIH had notified EcoHealth that it wants “a sample of the new coronavirus that the Wuhan researchers used to determine its genetic sequence,” along with study details and other information.

Additionally, the NIH demanded that EcoHealth “arrange for an inspection of the Wuhan Institute of Virology by an outside team that would examine the facility’s lab and records ‘with specific attention to addressing the question of whether WIV staff had SARS-CoV-2 in their possession prior to December 2019.’”

The problem, Mr. Martin notes in “Indoctornation,” is that while the evidence is staring us right in the face, we’re told that so-called “fact-checkers” have a transcendent view of the situation, and they are the ultimate arbiters of truth.
As a result, we have this very strange situation where facts and logic are being steamrolled and lambasted as good old-fashioned heresy.

Will Truth Prevail?

The film goes on to interview many other experts, many of whom are convinced the evidence points to SARS-CoV-2 being a manmade virus. Like Plandemic Part 1, Part 2 is well worth your time. As noted by Mr. Willis, in today’s fast-paced world, few have the time to do the necessary research to unveil what’s really going on.

The evidence is there, but you have to put it together. This is why documentaries such as “Plandemic” and “Shadowgate” are so useful. They weave the dots together so you can see a fuller, more complete picture.

Unfortunately, the picture at present is grim.

Yet we must face it because it’s not going away or resolving in the near future. It is important to understand that we are all being subjected to a massive propaganda campaign to move us toward a very specific technocratic agenda.

It is only by seeking alternative views that we can begin to understand the truth.

In the case of coronavirus, it should be clear that gain-of-function research is a dangerous game that should not be permitted.

By giving researchers the go-ahead to continue this kind of research, even as the NIH publicly “paused” funding for it, the NIH failed to uphold its moral and legal responsibilities.

It also seems the CDC has engaged in illegal activities relating to the patenting of the virus and that it had ample motive and means to profit from a coronavirus pandemic.

It’s hard to imagine a more corrupt system than what we currently have.

The question is: When will something be done about it?

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15 November, 2023

Study Reveals Most Common Chronic Symptoms After COVID-19 Vaccination

A new study shows some of the most common chronic symptoms among people who began experiencing the problems after receiving a COVID-19 vaccine.

The most common symptoms were exercise intolerance, excessive fatigue, numbness, brain fog, and neuropathy, researchers reported in the paper.

Insomnia, palpitations, myalgia, tinnitus, headache, burning sensations, and dizziness were also experienced by at least half of the participants in the study, which was funded in part by the U.S. National Institutes of Health (NIH).

Participants reported a median of 22 symptoms, with a ceiling of 35.

The study focused on people "who report a severe, debilitating chronic condition following COVID-19 vaccination" that "began soon after COVID-19 vaccination and persisted in many people for a year or more," the researchers said.

The study was led by Dr. Harlan Krumholz of the Department of Internal Medicine at the Yale School of Medicine and Yilun Wu of the Yale School of Public Health's Department of Biostatistics.

It was published on Nov. 10 as a preprint ahead of peer review.

Methods

The paper comes from Yale's Listen to Immune, Symptom and Treatment Experiences Now (LISTEN) research, which examines both so-called long COVID and post-vaccine adverse events.
Researchers began recruiting participants in May 2022. Participants filled out a survey, and researchers had access to their health records.

The study featured adults who reported post-vaccination problems from May 2022 through July 2023. The 388 people who also reported so-called long COVID, or lingering symptoms after COVID-19 infection, were excluded. Another 146 people who didn't completely fill out the survey were also ultimately left out.

The median age of the participants was 46, and 80 percent were female. Approximately 88 percent live in the United States.

The design of the study means no causality could be confirmed, the researchers said. While they acknowledged the chronic symptoms could be caused by the vaccines, they alleged they could also be unrelated and have occurred by change, but also said the clustering of symptoms soon after vaccination "suggests a potential relationship."

Known side effects of the vaccines include heart inflammation, severe allergic shock, and Guillain-Barré Syndrome.

Other issues have been linked to the vaccines by some but aren't recognized as widely as confirmed side effects.

The symptoms could be quite painful. Participants reported a median of 80 on a scale of 100 when asked how bad their symptoms were on their worst days.

Lingering Symptoms

In the week before completing the survey, 93 percent of participants said they felt unease at least once.
More than eight out of 10 reported feeling fearful, and 81 percent reported feeling overwhelmed by worries.

Feelings of helplessness, depression, hopelessness, and worthlessness were also commonly reported.

Nearly the entire group said they felt rundown and 91 percent said they suffer from sleep problems.

On the other hand, half of participants reported being in good, very good, or excellent condition. Still, the rest reported fair, poor, or unknown status.

The symptoms started for many people soon after vaccination. The median time of symptom onset was three days. Seventy-seven percent of people experienced the symptoms after their first or second shot.

The study followed an NIH-authored paper that detailed 23 people who experienced persistent symptoms following COVID-19 vaccination.

A number of participants in the new study received new diagnoses after receiving a vaccine, including anxiety, neurological conditions, gastrointestinal issues, and postural orthostatic tachycardia syndrome.

Problems Before the Pandemic

Nearly half the participants had allergies before the pandemic, according to the study. About three quarters of the participants in total had at least one comorbidity, such as allergies.

Behind allergies, the most common comorbidities were gastrointestinal issues, with acid reflux as an example; anxiety disorders; depressive disorders; and asthma.

Arthritis, an autoimmune disease, high cholesterol, hypertension of high blood pressure, and migraines were also reported each by more than two dozen people.

Treatments Tried

Many participants tried multiple treatments for their symptoms. Nearly all tried probiotics, which help boost good bacteria in the body.

Vitamins and supplements were also frequently turned to, with vitamins b12, c, and d and ibuprofen being the most popular.

Anti-inflammatory drugs, including ibuprofen, were used by a majority of participants.

Oral steroids such as dexamethasone were used by about half of the group.

Lifestyle changes were also common, with 51 percent limiting exercise or exertion, 44 percent cutting alcohol or caffeine, and 44 percent increasing or decreasing how much salt they consumed. Another approximately four in 10 changed their diet.

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Suing AstraZeneca in UK—VITT Litigation Group Represents COVID-19 Vax Injured & Bereaved

The VITT Litigation Group was formed in the United Kingdom (UK) as a group of vaccine injured or bereaved due to blood-clotting complications linked to Vaccine-induced thrombotic thrombocytopenia (VITT) due to the AstraZeneca vaccine originally developed at University of Oxford. Representing the individuals and families whose lives were devastated due to this COVID-19 vaccine, the group represents individuals who have suffered life-changing illnesses and disability or have been bereaved due to VITT. A total of 80 people make up the group today.

Importantly, holding big pharmaceutical companies accountable represents a challenge in the UK. This is true particularly when the societal pressure has been for mass vaccination of a product that was rushed to market in response to a declared national and global emergency.

Background

As the group reports on its website coroners across the United Kingdom, namely England and Wales, NHS doctors and expert medical advisors appointed by the Government have all confirmed that VITT is caused by the AstraZeneca vaccine.

Widely recognized, VITT is defined by the Royal Society of Hematologists in the UK. The group reports that all legal claims are based on a confirmed diagnosis of VITT by treating consultant or in bereavement cases, via coroner.

Importantly, a majority of the litigants suffering from this adverse condition were before the jab, fit, healthy and at low risk from COVID-19-related complications. It should be acknowledged as well that none of the COVID-19 vaccines were ever sterilizing, in that they failed to eradicate SARS-CoV-2 transmission.

Call for Support

The group seeks financial donations to support the two legal cases they have filed against the British pharmaceutical company. However, to protect the right of others in their group to bring legal action, they need to issue remaining cases in Court.

The group is currently in the process of raising Ł10,000 for the Court issue fees to avoid the remaining claims running out of time due to statute of limitation.

TrialSite provides the VITT Litigation Group CrowdJustice link.

Call to Action: A healthy, vibrant biopharmaceuticals industry trusted by the public will need to take accountability for injuries, particularly if they were the result of deceptive practices. We note here at TrialSite that the VITT Litigation Group declares it’s not “anti-vaxx,” only pro-equity and justice. Those that seek to defect from accountability use the anti-vaxx label as part of ad hominem attacks to discredit legitimate critical problems.

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14 November, 2023

No More COVID-19 Shots for Youth? A Bigger Politicization Agenda Behind COVID-19

“The real Covid jab scandal is finally emerging." A November 9 comment in The Telegraph provides a good introduction to the topic of why, when they faced little risk, we vaccinated kids for COVID-19. The conclusion is in the article’s subtitle: “The young and healthy, who were at minimal risk from Covid, should not have been told they had to take the vaccine.”

We learn that one Lisa Shaw, an award-winning BBC presenter, had her first COVID-19 vaccination on April 29, 2021. This 44-year-old mom thought she was doing her part to keep others safe. Within days, Shaw “developed a headache and stabbing pains behind her eyes which wouldn’t go away.” And by May 16, she was in hospital with blood clots in the brain. She could hardly speak, and a portion of her skull was removed to relieve pressure. Then, on May 21, Ms. Shaw died; the coroner found the death was due to the AstraZeneca COVID-19 vaccine.

“Ms. Shaw was previously fit and well,” yet it was “clearly established” that she died from a rare “vaccine-induced thrombotic thrombocytopenia (VITT).” VITT is “a new condition which leads to swelling and bleeding of the brain.” Back in 2021, UK Health Secretary Matt Hancock, as part of “strenuous efforts” to ease the public’s concerns, had said the AstraZeneca product was “a great British success story.” Prime Minister Boris Johnson even tweeted that, “It is truly fantastic news – and a triumph for British science….” Fast forward to yesterday, and TrialSite reported on a large lawsuit against that same vaccine in the UK maker—the plaintiff: the VITT Litigation Group.

“Severe brain injury”

Our next perspective comes from the BBC, also on November 9, “AstraZeneca faces legal challenge over Covid vaccine.” They note that the father of two, Jamie Scott, received his jab in April 2021, and that he thereby “suffered severe brain injury.” His case is being brought under the Consumer Protection Act and alleges that the product is “defective” in that it was more dangerous than folks were led to believe. Another 80 vaccine victims are due to launch a suit later in 2023. All are involved with the aforementioned VITT Litigation Group.

According to AstraZeneca, "Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines---Our sympathy goes out to anyone who has lost loved ones or reported health problems--From the body of evidence in clinical trials and real-world data, Vaxzevria [the vaccine against Covid] has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects."

“Vaccine-induced immune thrombosis and thrombocytopenia”
Many victims have obtained one-time Ł120,000 payments via the UK’s Vaccine Damage Payment Scheme. FOIA requests show that of 148 VDPS recipients, 144 had received that AstraZeneca product.

Scott’s wife Kate has told BBC, "Jamie has had over 250 rehabilitation sessions from specialists, he had to learn to walk again, to swallow, to talk. [He has had] memory problems---Although he has done very well with them, we are at the point now where this new version of Jamie… is the version that will go forward. He has cognition problems…he has aphasia. Severe headaches, blindness---We need the government to reform the vaccine damage payment scheme. It is inefficient and unfair…and then fair compensation." Within months of the AZ rollout, cases of post-vaccination blood clots began to arise. And the aforementioned “vaccine-induced immune thrombosis and thrombocytopenia (VITT) was eventually identified.”

Ironically, BBC is a target of a lawsuit TrialSite is participating in---a a key member of the Trusted News Initiative or “TNI.”

This media cabal consisting of top media and tech companies collaborated to ensure that critical message of the type TrialSite was reporting on was blocked from the public.

After presidential candidate Kennedy called TrialSite founder Daniel O’Connor to discuss the potential lawsuit, TrialSite joined to support what has been both censorship and a potential platform to destroy competition.

So, while the BBC has the green light to report on vaccine injuries now, back in early 2021, when TrialSite was one of the only media reporting on such events. They and the mainstream media followed national emergency scripts, chucking real journalism. So did the pharmaceutical trade press, TrialSite’s more direct competition. Not a peep to this day from the like about some of the more insidious externalities associated with COVID-19.

TrialSite reported on many of the front-line physicians who argued that the vast majority of COVID-19 cases were mild to moderate, especially among young people. This more independent, critical group of providers argued against the need for COVID-19 vaccination.

Put another way, the risks of vaccination outweighed the benefits, according to this cohort. The mainstream argument cited the surge in child hospitalization during Delta and the emergence of MIS-C as a reason for vaccination. Yet opinion contributors such as Geert Vanden Bossche have argued that this never justified mass vaccination of our youngest members of society.

TrialSite has repeatedly reported to the market that, to this day, the Food and Drug Administration (FDA) cannot verify the safety of Pfizer’s Comirnaty to the American public for both children and pregnant women.

Section 8.1 of the FDA packaged insert involving pregnancy:

“Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.” Section 8.4 for young children 12 and under states, “The safety and effectiveness of COMIRNATY in individuals younger than 12 years of age have not been established.”

Why are U.S. health authorities still pushing this vaccine on society’s most vulnerable people other than the elderly with no emergency, a case fatality rate at a level of influenza or even lower, and seemingly overwhelmingly mild to moderate upper respiratory infections, given the reports of side effects and no ability to verify the safety on the label?

WHO deprioritizes youth vaccination

Some nations are starting to get it, including the collection of health representatives that is the World Health Organization (WHO). On March 29, 2023, CNN offered another look at the subject of COVID-19 vaccines for youth, “WHO experts revise COVID-19 vaccine advice, say healthy kids and teens low risk.” They note that “The World Health Organization’s vaccine experts have revised their global COVID-19 vaccination recommendations, and healthy kids and teenagers considered low priority may not need to get a shot.”

This updated “roadmap” aims to “prioritize COVID-19 vaccines for those at greatest risk of death and severe disease, according to the World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE).” A SAGE press release offered that “The public health impact of vaccinating healthy children and adolescents is comparatively much lower than the established benefits of traditional essential vaccines for children – such as the rotavirus, measles, and pneumococcal conjugate vaccines.”

TrialSite reported on prestigious academic medical centers such as Murdoch Children’s Research Institute, which have studied the matter and all but concluded the push for COVID-19 vaccines should be used for the more traditional vaccine schedule now, given declining rates due to heightened hesitancy.

At the core of the problem is that the current COVID-19 vaccines’ efficacy and risk mix just don’t compel objective pediatric care and research inquiry.

Science and medicine have been completely politicized during the pandemic. We will not go back to a more sane and rational time when the professionals respected their respective lanes.

The Biden Administration’s mandates (some of which were ruled unconstitutional) were announced in 2021, when we already knew the COVID-19 vaccines failed to stop viral transmission and were associated with some dangerous side effects, albeit relatively rare. It doesn’t matter, given the ever-milder strains involving Omicron. Of course, there were still outlier severe cases, and the elderly continued to face higher risk.

This author suggests the Biden move was, behind the scenes, a power play meant to reign in on an emerging medical freedom movement that was identified by the Washington power structure as aligned with MAGA and Trump. After all, even before the outrageous September 6 actions, tensions between opposing political viewpoints were boiling over. It seems American society hasn’t been so divided since perhaps the Vietnam War, maybe even since the Civil War. Social media and changing cultural dynamics fostered an environment of tribal division based on lifestyles and self-identified clicks.

The Biden Administration continues to exploit the pandemic, even if it's over—there is no more emergency—with at least $5 billion in taxpayer funding used so bureaucrats in Washington can pick winning vaccines and other medicinal countermeasures. It’s as if we are in a continuous emergency, or put another way, a new politicized reality.

This isn’t to deny that Trump also politicized the pandemic. He did so as well, first trying to deny its risk, acknowledged in the Woodward interviews. Operation Warp Speed became a somewhat corrupted free-for-all with billions of taxpayer dollars changing hands.

Ominous Roots

Of course, we here at TrialSite cannot be 100% certain, but this author puts forth with 90%+ confidence based on the evidence we have secured that SARS-CoV-2 emerged from the laboratory. We have government documentation that alleges it’s a homegrown (American) technology, and we speculate that it likely leaked inadvertently at the Wuhan Institute of Virology (WIV).

We cannot be certain, and there is some evidence that the pathogen emerged before the Wuhan outbreak on both sides of the Pacific Ocean.

This is why it has been so difficult to discover the origin of this particular coronavirus, while the others (SARS-CoV/MERS) were discovered. All sorts of questionable actions have occurred. Even during the second investigation by WHO into the SARS-CoV-2 origins, the president of EcoHealth Alliance (Peter Daszak) was chosen to represent American interests. What? That’s the last person who should have traveled to Wuhan in early 2021.

This smelled as part of a broader coverup. EcoHealth Alliance has been all but proven to be part of a scheme to outsource gain-of-function to China on behalf of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. See TrialSite’s early timeline and concerns about origin in “Origins of the Pandemic are Elusive & Timeline Reveals Glimpse into Path to Better Tomorrow.”

Remember all of the back and forth between Rand Paul and Fauci? What ever happened? Why has Sen. Ron Johnson sent dozens of letters inquiring into this or that in these bureaucracies with no response? Like so many other inquiries, they are made more for show for the specific tribal following than anything else.

We suspect a cover-up that includes both the Chinese government but also elements in the American government, as well as others, with intelligence agencies used to run cover and interference.

Why did the Missouri legal case uncover a rat’s nest of government intelligence operatives on Twitter?

Likely, a government operation was ordered to run the cover, help shape the narrative, and incite division and conflict. Some evidence emerged that some elements in the Central Intelligence Agency sought to buy out analysts who would express their real concerns about origins.

And, of course, Dr. Anthony Fauci served a key purpose, but he is just one of many who are part of the coverup, should we be correct. And few individuals likely have a comprehension of the whole story.

Again, based on our educated estimates, there’s a 10% chance we are off the mark, and all of this is something different. This has to be understood. I must convey that this is an opinion piece and not the formal stance of TrialSite Inc., a Delaware and Utah corporation that officially takes a far more conservative stance.

Time to Wake Up—Positive Transformation

Regardless, we here at TrialSite suggest Americans need to become more informed, educated, aware, vigilant, and less tribal, as well as less subjective about the unfolding world of research and medicine.

We suspect pressures and momentum for permanent politicization now, hence the importance of well-designed research--of paramount importance for the generation of evidence, as are critical media outlets to interpret results, vet subtle and not-so-subtle bias (such as commercial bias), and the like.

That’s what TrialSite is about, translating and summarizing for a broader audience the results of biomedical and health-related research from preclinical through to post-approval marketing. Given investors’ influence in life sciences, we are embracing more based on subscriber requests for deep dives into investor-related news about research.

TrialSite remains committed to biopharmaceutical research and the amazing revolution now unfolding in medicine, such as the dramatic personalized-driven transformation of cancer care.

But industry and government have been too entangled, as was the case with Operation Warp Speed and now NextGen. Advanced capitalist societies show a tendency for more intermingling between government and industry in ingenious ways. This is especially the case when exposed to the competitive realities of government/industry models, such as with the People’s Republic of China.

But the very innovative breakthroughs that create exponential exchange value necessitate the individualism, market dynamics and, competition, and liberties that were created and need to be preserved in the West (here is more of a concept and not necessarily an actual place).

Yet only a more critically thinking, aware, rational, and educated public, organized based on common issues of concern, can demand and direct more insightful and healthier political leadership that will hopefully disentangle some of the more ominous advancements driving the American political economy.

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13 November, 2023

British Covid Inquiry is exposing lockdown’s dodgy models

Did we lock down on a false premise? Yesterday was Ben Warner’s turn at the Covid Inquiry. He was an adviser, and one of the ‘tech bros’ brought in by Dominic Cummings to advise No. 10 on data. He was present at many of the early Sage – and other – meetings where the government’s established mitigation (herd immunity) plan was switched to the suppression (lockdown) strategy.

In Dominic Cummings’ evidence to the inquiry last week, he said that models didn’t play a big part in moving the government towards lockdown. Part of the written inquiry evidence supplied by his data man, Ben Warner’s, supports that too. The Inquiry KC was keen to highlight this early on and flashed it up on screen: ‘It is not necessary to perform large scale simulations of an epidemic to understand the main effects of a mitigation versus a suppression strategy. Simple calculations allow for reasonable approximations of the outcome.’ Those ‘reasonable approximations of the outcome’ were that the NHS was going to be overwhelmed. Unless the harshest measures were imposed. Unless we locked down.

But these simple calculations and extrapolations are models too. They should be examined as such. It also cannot be denied that the models were then used as a comms tool for compliance. They were a not so subtle ‘nudge’ for Brits to do the right thing. They nudged advisers too.

Look further into the written statements – not just the bits highlighted by the KC – and Warner repeatedly mentions models, including those produced by Neil Ferguson. Indeed, of the importance of models for the eventual decision to lockdown his statement reads: ‘I am not aware of any meeting where the Prime Minister was asked to choose between a mitigation and a suppression strategy. But if that meeting had happened before the 15 March, I am confident that the right information and evidence was not put before him to inform the consequences of this decision, simply because Neil’s work did not exist before then.’ For these reasons, the models are certainly worth examining.

Models drive two fundamental points the inquiry is taking as established truth: lockdown works and lockdown was the only thing that could stop the NHS becoming overwhelmed. Almost every question the inquiry asks of any witness centres on these assumptions. In large part because many of those advising the government at the time also hold this view. But does the evidence support them?

Firstly, that lockdown works, is something the inquiry should seek to answer definitively. Indeed Lord Stevens, former NHS Chief Exec, said as much in his evidence last week. The second point – that lockdown was the only option – seems a flawed assumption too. There’s a growing body of evidence that Covid cases peaked before lockdowns were implemented – and not just in the UK. Google mobility data shows people taking their own precautions pre-lockdown too. But even more compelling is Sweden. Look at their first wave deaths compared with ours for the first wave. Different peaks but near identical trajectories.

To understand how these beliefs arose, and why they may be wrong, we need to look at the flaws within modelling as a discipline, and the specific type of models that were used during the pandemic. The code running them is described as ‘spaghetti’ code – meaning it’s built up and added to by different people over years and years and becomes an unruly mess that’s very difficult to decipher and therefore scrutinise. They’re a black box. The people using the results – ministers and advisors – just say what comes out. They don’t understand what goes on inside them. And the models (or at least not the prominent ones) did not react to live data.

But the flaw that undermined them more than any other is their total blindness to human behaviour change. They are built with a fundamental assumption. Only restrictions will bring down infections, and will bring down the R number. It’s hardcoded. It was ministers’ lack of understanding of this issue – perhaps more than anything else – that tipped the scales towards lockdown. It wasn’t until Omicron came along 18 months after the first lockdown that this became publicly apparent – giving us the perfect case study (as The Spectator pointed out at the time).

‘Deaths could hit 6,000 a day’, reported the newspapers on 17 December 2021. A day later documents for the 99th meeting of Sage were released which said that, without restrictions over and above ‘Plan B’, deaths would range from 600 to 6,000 a day. A summary of Sage advice, prepared for the Cabinet, gave three models of what could happen next:

Do nothing (ie, stick with ‘Plan B’) and face ‘a minimum peak’ of 3,000 hospitalisations a day and 600 to 6,000 deaths a day
Implement ‘Stage 2’ restrictions (household bubbles, etc) and cut daily deaths to a lower range: 500 to 3,000.
Implement ‘Stage 1’ restrictions (stay-at-home mandates) and cut deaths even further: to a range of 200 to 2,000 a day
After a long and fractious cabinet debate, the decision was to do nothing and wait for more data. ‘Government ignores scientists’ advice,’ fumed the BMJ. But the decision not to act meant that the quality of Sage advice could, for the first time, be tested, its ‘scenarios’ compared to actual.

The results were stark. On hospitalisations, beds occupied and deaths the models had vastly exaggerated what went on to happen. Human behaviour had been completely ignored even though by then the modellers had seen it first hand, not least in the ‘pingdemic’ of the summer that had just gone. Graham Medley – chair of SPI-M the modelling group – later described it to a parliamentary committee as: ‘By far the most effective three days in reduction of transmission that we’ve seen throughout the whole epidemic. Much more effective than any of the lockdowns’.

Whilst it took Omicron for the government and the public to realise this flaw, the modellers had known about it for years. Professor Neil Ferguson, when questioned on the issue at the inquiry, made that clear himself. Asked about Sage’s default assumption that only drivers of behaviour change were government restrictions, Ferguson mentioned an essay he had written in Nature in 2007. That essay – penned 13 years before Covid struck – contains many of the criticisms of the models discussed yesterday. ‘Today’s models largely ignore how epidemics change individual behaviour’, reads the subhead. The key quote from the piece is instructive: ‘Yet fundamental limitations remain in how well they [models] capture a key social parameter: human behaviour.’ He went on: ‘Most glaringly, the effects of behavioural responses to epidemics are given short shrift.’ The whole essay is worth reading. It sums up the glaring omission of self-motivated behaviour change. But it also begs a worrying question: why did government place so much weight behind them, despite this flaw being known 13 years before?

Even more baffling was why this affected the UK response specifically. Sweden managed to ignore models almost entirely, having been burnt by them in the past. The Danes even managed to reflect behaviour change in their models resulting in much more accurate outputs. Denmark’s Expert Group for Mathematical Modelling produced scenarios for Omicron hospitalisations that mapped well to reality.

Dr Camilla Holten-Mřller – who chaired the Danish modelling group – gave evidence to the select committee hearing Medley had. She explained that they were very conscious to factor in behaviour change into their models: when cases reached a certain level in a local area, people would mix less. So the model was designed to reflect that.

Beyond behaviour change there are three often quoted defences of modelling:

The models were scenarios not forecasts.

The media unfairly criticises the ‘worst case scenario’ models.

Sage could only model what the government asked it to. Hence no consideration of side effects or damage to education, the economy and health.

The first of these arguments has been dismissed by some of the modellers themselves. At a Royal Society conference chaired by Sir Patrick Valance in June last year, Professor Steven Riley of the UKHSA made the point: ‘We can’t redefine commonly used words. If we have a chart that’s got a time axis and the time axis goes past the current day and there’s a line going off to that side of the chart then we are making forecasts. Whether we like it or not.’

The second – that we in the press paid too much attention to what were worst case scenarios – was picked apart by Professor Ferguson. He told the inquiry: ‘I was always uncomfortable with labelling what I felt was our central estimate as being the reasonable worst case. Because calling it the reasonable worst case, even if in theory policymakers are meant to be planning to it, makes it sound like it’s an unlikely eventuality, whilst in my view it was the most likely eventuality if nothing more was done.’ So: worst case scenarios were not seen by all as unlikely.

The third: that government asked the wrong questions – is harder to answer. Perhaps Baroness Hallet will get to the bottom of that in the years to come. But what’s clear now is the state has learnt nothing about the peril of using the modelling discipline. Look at the modelling paper used to justify Rishi Sunak’s smoking ban. That model spits out four scenarios. Each of them show a reduction in smoking, with three out of the four seeing smoking completely eradicated by 2050. A brilliantly successful policy then? But then look at the modelling assumptions: ‘In all scenarios, the model assumes smoking instigation rates reduce year-on-year to reflect ongoing increases in the age of sale.’ They spell it out in black and white. The key assumption for the model – the input to the black box – is that the policy works. There is no data you could put into that model that would even allow you to consider the possibility of no reduction in smoking and a massively illiberal policy failure.

The smoking models are trivial compared to those produced during the pandemic years – but they highlight the need for security. As more and more evidence from the inquiry comes out it’s clear how influential models are too, even if just to confirm what seemed obvious from more basic data. It’s hard to blame advisors, ministers and scientists for decisions made early on. Locking down while we figure things out was a perfectly reasonable approach. To look at and build the evidence. But was that time used to scrutinise the models? Consider less harmful approaches? The inquiry should try to find out.

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Australian Medical Society Reports on Excess Deaths: Claims They Are Linked to COVID-19 Vax

An Australian medical professional society formed to protect and promote the interest of members in matters concerning their respective employment or professional engagement has been actively looking into problems with the COVID-19 government narrative, namely, the delta between the goals of the mass vaccination response to COVID-19 and the real-world data suggesting ongoing excess mortality.

The Australian Medical Professionals Society (AMPS) recently announced “Too Many Dead 2023: An Inquiry into Australia’s Excess Mortality,” a freely downloadable book investigating the troubling excess death rates Down Under, starting in 2021. They also held a conference late last month.

Political and medical authorities in Australia continue to evade the topic—perhaps even labeling activists investigating the disturbing trends as “anti-vaxxers.” In fact, the Australian Senate even held a vote to not have an inquiry into the excess deaths, which seems counter intuitive given their role as representatives of the people of Australia.

Regardless, AMPS and other concerned medical professionals initiated its own independent, dedicated investigation into the matter, the results of which accumulated in the data that was used to author the book.

AMPS reports that despite the severe limitations in some cases of current governmental regulatory pharmacovigilance systems, large numbers of adverse events, disability and deaths become continuously commonplace.

The claim: This group has come outright and declared that the vaccination programs meant to protect the people of Australia from SARS-COV-2, the virus behind COVID-19 are in fact, the cause of the excess deaths. An “iatrogenic” driven excess mortality, meaning these deaths according to these medical professionals are directly the result of the mass COVID-19 vaccination program.

How many excess deaths? AMPS alleges that after the extensive examination of the public health data, the excess mortality surges 12-17% above baseline averages, rates never seen since wartime. The apex of excess mortality surged in early 2021 and has persisted at what they group terms “unusual levels to this day.”

Of course, the mass vaccination program’s commencement did coincide with the start of 2021. TrialSite reported that by the end of the year, much of the Australian population was vaccinated yet in the first three-and-a-half months of 2022, twice as many people died in Australia from COVID-19 than in all of 2020 and 2021. In part, this can be explained by severe lockdowns in Australia. Inspired to some extent by Chinese “zero tolerance” COVID measures, Australia kept the virus at bay in much of 2020, and throughout parts of 2021.

Then, the majority of people got vaccinated, and restrictions and behaviors eased up, yet Delta and of course, the Omicron variants continued to circulate. Could it be that with waning vaccine durability and a lack of natural (preexisting infection) immunity in the population deaths then surged?

Regardless, the excess deaths are not only in Australia but observed worldwide. Back in Australia, AMPS has taken an active role to research and educate those interested in learning about this ongoing problem. In addition to the recently held conference they have held inquiries, communicated concerns with both politicians and regulators and various government agencies.

The recent conference last month featured some serious academic such as Professor Normal Fenton, a skeptical Professor Emeritus of Risk at Queen Mary University of London (retired as of Dec. 2022) and Director of Agena, a company that specializes in artificial intelligence and Bayesian probabilistic reasoning.

With several books and over 350 peer-reviewed articles, TrialSite has from time to time during the pandemic updated readers on some of his concerning analysis in the United Kingdom. Specifically for the UK, Fenton and colleagues have spent significant time and effort to show statistically how the COVID-19 vaccines appear to be associated with excess mortality.

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12 November, 2023

Growth in COVID-19 Adverse Events in VAERS

A recent Op-ed on Cancer events (post-COVID-19 vaccination) reported in VAERS (Vaccine Adverse Events Reporting System) examined in part the temporal increase of specific Cancer events from 2022 to 2023 post-COVID-19 vaccination. There were some Cancer events that experienced very rapid growth compared to the overall average. These results led to the conclusion that there would be value in identifying temporal increase of symptoms/diseases other than Cancer post-COVID-19 vaccination. The present Op-ed identifies temporal growth patterns of selected adverse events (from VAERS) that occurred post-COVID-19 vaccination. It does not identify post-COVID-19 vaccination long-term adverse events since these would take at least five years to emerge, and perhaps decades more.

METHODOLOGY

On 26 October 2023, CDC Wonder (a search engine for VAERS) was accessed, and searches were performed to identify symptoms (which in some cases are usually referred to as diseases) reported in VAERS for the periods ending in 2021, 2022,and third quarter 2023 (restricted to USA and Territories, COVID-19 vaccines). Selected symptoms were compared for the 2021, 2022, and 2023 periods, and patterns of temporal increase were discussed.

The symptoms were selected for specific broad disease categories based on key symptom findings from previous Trial Site News (TSN) Op-eds written by the author. These disease categories included Cancer (Link#1: Link#2), Cardiovascular, Neurological, Autoimmune, Endocrine, Reproductive-Pregnancy, Blood-Lymph, and Gastrointestinal. Symptoms from the Infections category were included as well.

RESULTS

Table 1A-1 shows the temporal increases in the selected symptoms/diseases. The column heading Code is:

Column 1 – CAT: the system/organ class for which the symptom is most appropriate. The category code shown for selected symptoms is 1) AUT=Autoimmune Disease; 2) BLD=Blood Disease;
3) CAN=Cancer; 4) END=Endocrine Disorder; 5) GAS=Gastrointestinal Disease; 6) HRT=Cardiac Disease; 7) INF=Infectious Disease; 8) NEU=Neurological Disease; 9) REP=Reproductive Problems.

Column 2 – SYMPTOM: the symptom as shown in VAERS;

Column 3 - #EV 2021: the number of cumulative events in VAERS at the end of 2021 (the number of times a symptom is reported is listed as the number of events);

Column 4 - #EV 2022: the number of cumulative events in VAERS at the end of 2022;

Column 5 - #EV 9-2023: the number of cumulative events in VAERS at the end of Sept 2023;

Column 6 - #EV 12-2023: the number of cumulative events in VAERS at the end of Dec 2023. This number was obtained by linearly extrapolating the number of events that occurred ONLY in the first nine months of 2023 to twelve months and then adding the twelve-month 2023-only number to the cumulative number of events recorded at the end of 2022;

Column 7 - RAT 2022/2021: the ratio of 1) cumulative events in VAERS at the end of 2022 to 2) cumulative events in VAERS at the end of 2021;

Column 8 - RAT 9-23/2022: the ratio of 1) cumulative events in VAERS at the end of Sept 2023 to 2) cumulative events in VAERS at the end of 2022;

Column 9 – RAT 12-23/2022: the ratio of 1) cumulative events in VAERS at the end of Dec 2023 to 2) cumulative events in VAERS at the end of 2022;

Column 10 – RAT 9-23/2021: the ratio of 1) cumulative events in VAERS at the end of Sept 2023 to 2) cumulative events in VAERS at the end of 2021;

Column 11 – RAT 12-23/2021: the ratio of 1) cumulative events in VAERS at the end of Dec 2023 to 2) cumulative events in VAERS at the end of 2021.

The entry INF in the ratio columns represents Infinity and signifies division by zero.

DISCUSSION

Integrity of the VAERS Database

The data used for analyses in the present study come directly from VAERS reports available to the public. Deficiencies in the VAERS data will translate directly to limitations and deficiencies in the results and conclusions. Thus, it is important to understand the integrity of the VAERS database.

The VAERS database is managed jointly by the Centers for Disease Control and Prevention (CDC) and Federal Drug Administration (FDA). VAERS documents a small fraction of the adverse events that occur after any vaccine is administered. As of 29 September 2023, 989,033 adverse events were listed in VAERS (data obtained using CDC Wonder) for COVID-19 vaccines, whereas 810,033 adverse events (Symptoms, in VAERS terminology) were listed in VAERS for all other vaccines since ~1990. Thus, VAERS appears to have documented more adverse events post-COVID-19 vaccines (starting early 2021) than from all other vaccines combined (starting ~1990)!

VAERS uses the MedDRA (Medical Dictionary for Regulatory Activities) vocabulary to represent each of the ~18,000 symptoms listed in VAERS. MedDRA consists of five hierarchical levels of symptoms/diseases: System Organ Class (SOC), High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT); Lower-Level Terms (LLT). Only a subset of the bottom level is used for the VAERS terminology.

There are questions concerning the integrity of VAERS itself. There is no chain-of-custody record for VAERS data available to the public. The substack “Welcome the Eagle” has been tracking the contents of VAERS since at least early 2021 and has been reporting myriad manipulations of data by the VAERS database managers. A useful summary of the “Welcome the Eagle”-based VAERS manipulations is presented in the linked viewgraph summary.

One of the many issues shown in this comprehensive viewgraph summary is the extensive delay period from receipt of the data by CDC to when it is reported in VAERS. In some cases, it was shown to be well over a year. This is of particular concern for the present study, where the time occurrence of events is central to the analysis. For some long-latency diseases, such as cancers, the latency period compounded by the long report processing time could extend the actual VAERS reporting date well beyond the study horizon and the full extent of the COVID-19 vaccines’ (administered from late December 2020 to end of September 2023, the study period covered by the present Op-ed) impact would not be shown.

What would motivate such manipulations? The VAERS database is co-managed by the CDC and FDA. These organizations have allowed Emergency Use Authorization of the COVID-19 “vaccines” despite lack of adequate testing/clinical trials (or, in some cases, absence of human clinical trials) and have declared these injections to be safe and effective despite copious evidence to the contrary. Because these co-managers of VAERS will have to take their share of responsibility for the massive numbers of adverse effects from the COVID-19 injections that have been reported, it is probably safe to assume that any manipulations of VAERS under their co-management would be in the direction of suppressing the scope and number of adverse events. Thus, for the above and many other reasons, the numbers reported in VAERS, even when corrected with Under-Reporting Factors (URF), should be viewed as a very low floor on the scope and number of real-world adverse events.

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Biden’s COVID-19 Vax Mandates Spawn Lingering Bad Results

Last July, the highly productive House Select Subcommittee on the Coronavirus Pandemic, chaired by Rep. Brad Wenstrup, R-Ohio, conducted a hearing into the science and impact of the Biden administration’s vaccine mandates.

Biden, his congressional allies, and many medical societies insisted that these unprecedented government mandates were benign and beneficial. As Rep. Raul Ruiz, D-Calif., opined during the hearing, “I believe the vaccine is safe and effective. I believe it is the role of public health to vaccinate as many people as possible to prevent the spread of the virus.”

Well, it turns out that the robotic repetition of the “safe and effective” mantra deserves some sober qualifications. Over the past two years, there has been mounting evidence of adverse health consequences from the COVID-19 vaccines.

The simple fact is this: the COVID-19 vaccines, aiming to prevent grave illness and death, nonetheless can carry serious risks. As The New York Times recently reported, even among the elderly population, the prime candidates for vaccination, there are risks.

Based on preliminary research from the Food and Drug Administration and the Centers for Medicare and Medicaid Services, there’s a heightened risk of stroke when older patients received the vaccine at “the same time” as the flu vaccine.

According to the New York Times account: “Those who received both COVID and flu vaccines saw a 20 percent increase in the risk of ischemic stroke with the Pfizer BioNTech bivalent shot, and an increase of 35 percent in the risk of transient ischemic stroke after the Moderna bivalent shot. (The bivalent shots were replaced in September with new formulations.)”

Since the Select Subcommittee hearing in July, new scientific reports reinforce the case for caution.

For example, researchers writing in the journal Biomedicines in August conducted a comprehensive literature review and confirmed that the spike protein found in both SARS-CoV-2 and the COVID-19 vaccines is clearly pathogenic with a wide range of adverse effects, including cardiovascular and neurological consequences.

Likewise, researchers writing in the British Journal of Pharmacology in October found that the leading COVID-19 vaccines can increase cardiovascular risks. Confirming previous findings, the Centers for Disease Control and Prevention is still reporting a risk (although small) of myocarditis/heart inflammation among young adult males.

That finding is directly relevant to any vaccine-mandate policy, whether publicly or privately enforced, and that’s why many states have banned COVID-19 vaccine mandates for schoolchildren who are largely invulnerable to serious illness and death from the novel coronavirus.

House investigators also noted the deleterious effect of vaccine mandates on the doctor-patient relationship. Wenstrup observed that the determination about whether to undergo a medical treatment or procedures is usually made between a doctor and a patient, but instead, he noted, “the Biden administration inserted itself and defiled this sacred relationship that we as Americans have always treasured.”

It’s standard ethical practice for a doctor to provide a patient undergoing a medical intervention with information on the risks and benefits of a given procedure, and the patient responds by signing and dating a form certifying his or her informed consent.

Whenever a patient is confronted with a personal risk, his or her personal consent (not public coercion) is the only ethical imperative.

The problem of vaccine coercion, however, has not been confined to the public sector. Allison Williams, a reporter with ESPN, was a Select Subcommittee witness. On the advice of her personal physician, because she was taking fertility treatments, she refused the COVID-19 vaccine. That refusal, she testified, cost Williams her job.

Physicians, too, have been subject to coercion. While questioning Williams, Rep. Ronny Jackson, R-Texas, a doctor, related his conversations with fellow physicians who were likewise threatened with dismissal: “Hospital CEOs, mostly non-physicians, came after doctors and nurses that didn’t parrot the government’s vaccine talking points, and state medical boards threatened to take licenses away.”

Today, only 3.6% of Americans thus far have gotten the new COVID-19 shot. There has also been a decline in other vaccinations.

While Biden’s congressional allies, among others, attribute this decline to “misinformation,” Dr. Kevin Bardosh of the University of Washington in his subcommittee testimony blamed coercive COVID-19 vaccine policies:

Our analysis strongly suggests that mandatory COVID-19 vaccine policies have had damaging effects on public trust, vaccine confidence, political polarization, human rights, inequities and social well-being.

We question the effectiveness and consequences of coercive vaccination policy in pandemic response and urge the public health community and policymakers to return to nondiscriminatory, trust-based public health approaches.

Exactly.

Mandates are blunt instruments. Because they inflict a lot of collateral damage, blunt instruments make bad policy.

Biden’s attempted imposition of these mandates two years ago largely failed, but the damage they inflicted survived their demise. They compromised the doctor-patient relationship, further undermined public trust, and based on emerging scientific evidence, overrode legitimate safety concerns. That’s a hard lesson.

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10 November, 2023

Nearly 1 In 3 Covid Vax Recipients Suffered Neurological Side Effects

Almost a third of individuals who received a COVID-19 vaccine suffered from neurological complications including tremors, insomnia, and muscle spasms, according to a recent study published in the journal Vaccines.

The study analyzed 19,096 people who received COVID-19 vaccines in Italy in July 2021, out of which 15,368 had taken the Pfizer vaccine, 2,077 had taken the Moderna version, and 1,651 took the AstraZeneca version.

While both Pfizer and Moderna are mRNA vaccines, AstraZeneca, being an adenovirus vaccine, uses a different mechanism to trigger the immune response.

The study found that about 31.2 percent of vaccinated individuals developed post-vaccination neurological complications, particularly among those injected with the AstraZeneca jab. Different vaccines had a different “neurological risk profile.”

The neurological risk profile of the AstraZeneca vaccine included headaches, tremors, muscle spasms, insomnia, and tinnitus, while the risk profile of the Moderna vaccine included sleepiness, vertigo, diplopia (double vision), paresthesia (a feeling of numbness or itching on the skin), taste and smell alterations, and dysphonia (hoarseness or loss of normal voice).

None of the subjects were hospitalized or died.

As to Pfizer vaccines, researchers found “an increased risk” of cognitive fog or difficulty in concentration.
AstraZeneca Risks

More than 53 percent of individuals who took an AstraZeneca shot suffered from headaches, which usually lasted for one day. Over 13 percent developed tremors, which typically reverted after a day as well.

Insomnia was reported among 5.8 percent of AstraZeneca recipients. However, the study notes that researchers were unsure whether the individuals actually developed insomnia or had a “misperception of their sleep quality due to vaccination stress.”

Tinnitus was reported by 2.7 percent of the people who took AstraZeneca shots. Tinnitus is a condition in which an individual hears ringing or other noises which are not caused by an external sound.

All these health complications had a higher risk of occurring after taking the first dose of the vaccine.

The study speculated that complications related to the AstraZeneca vaccine are attributable to two factors. “Firstly, the nature of the vaccine, which is a modified adenovirus vector that results in significant and persistent systemic immune activation; secondly, individual vulnerability related to a predisposing biology.”

Moderna And Pfizer Risks

Sleepiness was found in 39.7 percent of those who took Moderna jabs, with the condition usually lasting for a week. It suggested that there “could be a strict relationship between the development of sleepiness and immune responses to vaccine/infection.”

The study cited a “fascinating hypothesis” which suggests that influenza vaccines may lead to “the selective immune-mediated destruction of orexin-producing neurons, which is T-cell-mediated neuronal damage, thus triggering narcolepsy.”

Narcolepsy is a condition in which the brain is unable to control the ability to sleep or stay awake.

“Considering that the same can occur for COVID-19 vaccines, future investigations monitoring the new-onset hypersomnia findings in vulnerable individuals are urgently needed.”

Hypersomnia is the inability to stay awake and alert during the daytime, even though the person may have had plenty of sleep during the night.

About 15.9 percent of people who received Moderna shots had vertigo, a sensation which makes the individual feel that they or their surrounding environment is moving or spinning. It typically lasted for a day.

Paresthesia—a feeling of numbness or itching on the skin for no apparent reason—was reported in 14.5 percent of Moderna vaccine recipients, which went away after a day.
Among the people who received a Moderna jab, 2.7 percent reported diplopia, also known as double vision, which also lasted for about a day. “Symptomatic people showed an increased risk to develop diplopia after the second dose, as if a reactivation of the immune response was necessary to trigger diplopia.”

Meanwhile, about 6.4 percent of Pfizer vaccine recipients reported suffering from cognitive fog, with the condition usually reversing in a week.

“Brain fog is a type of cognitive impairment that presents as a ‘foggy brain state’, including a lack of intellectual clarity, difficulty with concentration, mental fatigue and anxiety,” the study said.

“Hypotheses including systemic inflammation crossing the blood–brain barrier, neuroinflammation after viral infection leads and microglial activation are emerging as explanations of this phenomenon in COVID-19 patients. An alternative speculation is that symptomatic people may have a subclinical cognitive dysfunction before vaccination, and that vaccination is a trigger.”

Females Highly Affected

The study found that females faced an “increased risk of developing neurological complications” following COVID-19 vaccination. “Our findings are in line with those of a recent study that revealed that several factors, including the female sex, were associated with greater odds of adverse effects,” it said.

The researchers suggested that greater female susceptibility to the vaccines’ neurological complications may be due to “genetic and hormonal factors.”

Females have two X chromosomes while males have one X chromosome and one Y chromosome. As the X chromosome “contains the most prominent immune-related genes in the human genome,” it can also cause “stronger inflammatory immune responses,” the study said.

Moreover, a primary female sex steroid called estradiol triggers a specific immunity process to produce “antibodies against infections.”

The study also raised concerns about comorbidities. In medical parlance, comorbidity describes the existence of more than one disease or condition in a body at the same time, which may or may not interact with one another.

“The evidence that immune system dysfunctions (allergies/immunodeficiency disorders) are frequently reported in our symptomatic group is more than a chance occurrence,” researchers said.

Comorbidities were present in 47.6 percent of the AstraZeneca vaccine recipients, 38.8 percent of those who took Moderna jabs, and 41.5 percent of individuals who received Pfizer shots, the study said.

In the AstraZeneca group, both allergies and non-neurological diseases were reported. “A history of antitumoral and anticoagulant drugs was more frequent in this population,” the study said.

Among Moderna and Pfizer recipients, allergies were “more frequently” observed. While some people who took Moderna had a prior history of neurological diseases and transfusions as well as previous COVID-19 infection, those who received Pfizer vaccines had a history of immunodeficiency disorders.

Even though the study detailed neurological complications arising from COVID-19 vaccination, it admitted to certain limitations.

“Firstly, our results should be interpreted with caution because of a possible overestimation of neurological events resulting from the self-reported symptoms,” it said.

“Secondly, we evaluated the risks associated with the first and second doses of the vaccine; however, the data concerning the second dose were limited, thus representing a potential bias in the study.”

While admitting its limitations, the study concluded that “clinicians should be aware that several neurological complications may commonly occur after COVID-19 vaccines.”

“Caution should be used when administering COVID-19 vaccines to vulnerable people, such as to those who suffer from allergies,” the study stated. “We strongly believe that our findings are relevant for public health regarding the safety of vaccines in a large cohort.”

The Epoch Times reached out to Moderna, Pfizer, and AstraZeneca for comment.

Additional Neurological Findings

Cardiologist Dr. Peter McCullough wrote about the study discussing neurological effects following COVID shots in an article on Substack.

“A shocking 31.2 percent of respondents to this large dataset sustained neurologic injury after two injections with verified data in health registries,” he wrote. “Most of the risk estimates indicate the safety profile is unacceptable. It is alarming that all neurological societies to date still recommend COVID-19 vaccines and none have issued safety warnings on the products.”

Dr. McCullough explained that an excess risk of 20 percent or greater is considered “clinically important.”

Multiple other studies have found evidence of COVID-19 vaccines being linked to neurological complications. Back in October 2021, a study published in the Neurological Sciences journal stated that the “most devastating neurological post-vaccination complication is cerebral venous sinus thrombosis (CVST).”

CVST occurs when a blood clot develops in the venous sinuses of the brain. This blocks the blood from draining out of the brain, eventually resulting in the blood leaking into brain tissues and forming a hemorrhage, according to Johns Hopkins Medicine.

The study found that CVST was “frequently reported in females of childbearing age,” generally among those who took an adenovector vaccine. Individuals who received mRNA vaccination were reported to have Bell’s Palsy, in which facial muscles weaken or enter into paralysis.

A November 2022 study in Current Neurology and Neuroscience Reports made similar findings, stating that there is “a greater than expected occurrence of severe neurological adverse events.”

Dr. McCullough cited this study in an article the following month. “Because the vaccines contain lipid nanoparticles loaded with genetic material that code for the damaging Spike protein, each patient faces a Russian Roulette of whether or not the nervous system will be hemodynamically showered with the damaging vaccine particles,” he wrote.

Despite studies suggesting the risk of medical complications, some experts continue to advise people to get COVID-19 jabs. According to John Hopkins Medicine, both Pfizer and Moderna are “highly effective in preventing serious disease, hospitalization, and death from COVID-19.”

It recommended people to get a COVID-19 shot as “we believe that their benefits outweigh their risks,” Johns Hopkins Medicine said.

According to a position statement from the American Academy of Neurology (AAN) issued in 2021, the organization recommended COVID-19 vaccine mandates for health care employees and supported vaccinations for children under the age of 12.

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9 November, 2023

Psychosis, Panic Attacks, Hallucinations: Bizarre Psychiatric Cases Among the COVID Vaccinated

Dr. Patrick William Slater is a 60-year-old neurotologist. A few years ago, he had a full-time medical practice in Austin and enjoyed hunting and fishing in the mountains during his downtime.

Then, in October 2021, Dr. Slater came down with cerebellar ataxia, a disease affecting movement. He couldn’t eat or go to the bathroom without help.

While his ataxia could be managed using drugs, it wasn’t always effective against his biggest complaint: unprecedented panic attacks.

Almost every night, Dr. Slater would experience panic attacks that left him in “abject terror.” He thought about killing himself many times, he told The Epoch Times.

No one could provide a satisfactory answer about why he had developed these symptoms. Nothing abnormal showed up on his laboratory reports, and his neurologists and psychiatrists dismissed his symptoms as anxiety.

But Dr. Slater is convinced that the COVID-19 mRNA vaccines are the culprit.

Dr. Slater was suspicious when the symptoms first appeared within about two weeks of getting the second dose of the COVID shot. The second—and worse—wave of career-ending symptoms had coincided with his third shot.

After taking the booster, “there was no question in my mind,” Dr. Slater said.

Psychiatrist Dr. Amanda McDonald noticed a wave of psychiatric destabilization among her stable patients. They experienced flare-ups, often manifesting with worsened or new psychiatric symptoms.

"I couldn't figure out why," Dr. McDonald told The Epoch Times. "My patients typically stay stable." But many stable patients were suddenly arriving at her office with insomnia, depression, and anxiety "without any sort of rhyme or reason."

She increased some patients’ medication doses or added new drugs to their regimen, but it had little effect.

A recurring pattern Dr. McDonald sees is atypical panic attacks, which can feel like having a heart attack. Brought on with no apparent trigger, symptoms typically escalate as the evening progresses and climax at night. A typical panic attack can occur anytime throughout the day but often has triggers, and it is easy to treat if patients can avoid these triggers.

After spending over a year following her patients, Dr. McDonald realized that COVID-19 vaccines may be linked to their psychiatric illnesses.

"I already had an existing patient population when the pandemic hit that I knew very well. What I saw was manifestations in that patient population,” Dr. McDonald added.

Dr. Diane Counce, neurologist and neuroradiologist, observed an increase in severe anxiety and worsened mood.

"People also talk about how their personality has changed," she told The Epoch Times. In cases where a family member has brought in a patient, "[The family] will say, ‘they're just different.’"

Nurse practitioner Scott Marsland, who has treated hundreds of long-COVID and vaccine-injured patients at the Leading Edge Clinic, added that debilitating anxiety, depression, and insomnia are among the most common symptoms he has seen. However, some patients have also developed hallucinations and suicidality.

The Evidence

Unlike myocarditis, no conclusive proof exists that COVID-19 vaccinations cause psychiatric illness. A multitude of studies, however, have linked COVID-19 vaccines with psychiatric symptoms, including depression, anxiety, panic attacks, psychosis, and suicidality.

The Vaccine Adverse Event Reporting System (VAERS) is a self-reporting database co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), used to surveil for early warning signs of potential adverse reactions. VAERS has documented over 9,400 and 1,600 cases of anxiety and depression, respectively, in relation to the COVID-19 vaccines. The vaccines comprise, respectively, over 60 percent and up to 50 percent of all anxiety and depression reports on VAERS.

Other less common adverse reactions include 1,500 reports of panic attacks (over 80 percent of VAERS reports), over 1,100 cases of hallucinations (over 65 percent), and 975 cases of irritability (10 percent).

Some researchers argue that the rare and fatal cases reported on VAERS may be a sign the system is being abused. In contrast, others believe they suggest a potential link to the vaccine and are worth investigating.

Psychosis

Psychosis includes both hallucinations and paranoia. Acute episodes after taking the shots have been reported in case studies.

In Brazil, a previously healthy woman in her late 30s developed refractory psychosis within 24 hours of getting the mRNA COVID-19 vaccine. She was aggressive, had disorganized thoughts, and believed she was being persecuted in the hospital.

Doctors treated her with antipsychotics and mood stabilizers, but four months of hospitalization later, only her behavior had improved. Her psychosis remained.

In Taiwan, a 15-year-old boy was sent to the hospital with agitation and uncontrollable limb stretching and screaming two days after his second Pfizer shot.

He exhibited bizarre behaviors in the hospital, including sitting up and lying down frequently with mannerisms like praying in the bed. He was prescribed antipsychotics, but the behavior persisted for over a month after discharge.

Doctors then put him on a steroid regimen. Steroids are anti-inflammatory and can help calm an overactive immune system. The boy's symptoms improved.

In India, a 17-year-old girl who received an inactive COVID-19 vaccine developed psychosis within 48 hours. She became restless and suspicious, talked to herself, and had insomnia for a month.

She had no neurological abnormalities, and all her lab tests came back normal, including a COVID-19 test. Two weeks after being given psychoactive drugs, her symptoms resolved.

Symptoms onset shortly after vaccination, exclusion of other likely causes, and absence of genetic predisposition "indicate the psychiatric adverse event may be related to the vaccine," researchers from All India Institute of Medical Sciences and District Hospital wrote in the case report.

Cases of psychosis lasting several days, weeks, and months have also been reported in the literature.

Suicides and Suicidality

According to React19, a nonprofit advocacy group supporting people with postvaccine symptoms, suicide is a present risk for people with vaccine injuries. However, often, it is hard to determine whether people become suicidal due to their injuries becoming too unbearable or due to a primarily physiological reaction to the vaccine.

The CDC's review of deaths reported after Pfizer vaccines found 14 deaths among vaccinated teenagers, two of whom died by suicide, with reasons unknown.

A study on 250 dental staff in Pakistan found that nearly 12 percent reported suicidal thoughts for a few days after vaccination. Around 1 percent had thoughts of suicide every day.

Individual case studies identified a Turkish man in his late 50s with no prior mental illness who arrived at the emergency department due to an attempted suicide within three days after taking a second shot. He was irritable, insomniac, and talking to himself.

A Japanese man's case was vividly detailed by doctors from Wakayama Medical University (pdf). He experienced fatigue after the first booster shot and, upon his fourth shot, developed a mild headache and a floating sensation.

Four days after vaccination, however, he became highly talkative with grandiose delusions, "saying that he had won 2 billion yen in horse racing. He also presented with emotional instability, such as crying when saying 'Everyone would be happy.'"

The neurologist he saw found no neurological disorders, such as possible encephalitis, nor signs of infection. Over a week after vaccination, he jumped from the second floor of his house and was returned to the hospital by ambulance.

Suicide cases have been rising in the United States since the pandemic. In 2020, the CDC reported up to 46,000 suicides (pdf). This number increased to over 48,000 in 2021, and in 2022, nearly 50,000 people died by suicide. While pandemic restrictions like lockdowns and long COVID have been linked with suicides, no studies currently link increasing suicide rates with the COVID-19 vaccine.

Overlap With Cognitive Impairments

Psychiatric symptoms can also overlap with cognitive impairments like reduced memory. Dementia, for example, can manifest symptoms like depression.

Dr. McDonald treated a vaccinated patient who developed dementia-like depression. The patient, despite being in her 90s, was highly independent and lived by herself. After getting the booster, she was diagnosed with dementia and placed in a nursing home.

Taking ivermectin reversed her symptoms.

Neurologists like Dr. Suzanne Gazda, however, are concerned about untreated cases. "There are so many people that don't even realize that they're injured."

Dr. Gazda has an integrative practice that treats thousands of patients with neurodegenerative diseases, and many report symptoms of cognitive decline with psychiatric symptoms.

Dr. Counce also has several vaccinated patients who developed brain atrophy. One patient had hippocampal atrophy with symptoms of memory loss and personality changes.

Dr. Counce reasoned that if the hippocampus, which serves as the brain's memory center, atrophies, the adjacent limbic system, which processes emotions, may be similarly affected.

But how exactly can vaccines lead to a person's change of mental status and personality?

According to doctors who treat both postvaccine and post-COVID conditions, the two syndromes are quite similar in their symptoms.

Both the COVID-19 virus and the vaccines expose patients to the viral spike protein, which could cause inflammation. Depression is the disease best known for correlating with inflammation, though bipolar disorder, schizophrenia, and anxiety are also linked.

mRNA technology has long been studied, and pre-2020 research clearly shows that mRNA vaccines are highly inflammatory, holistic psychiatrist Dr. Aruna Tummala told The Epoch Times.
Dr. McDonald has found that anti-inflammatory drugs and therapeutics, such as ivermectin, hydroxychloroquine, and hyperbaric oxygen therapy, often help patients stabilize their moods.

She prescribed ivermectin for her psychiatric patients who were destabilized after taking the vaccines and saw significant improvement.

As a doctor who treated hundreds of vaccine-injured and long-COVID patients, one day, she herself developed long COVID after infection. She woke up with unexplainable negative thoughts. "I put myself in a hyperbaric machine," she recalled, and 10 minutes after, "my mood symptoms had disappeared.”

Blood clotting, a common harm caused by spike protein, reduces the oxygenation of tissues and renders them unable to function at optimum levels, forcing them to age.

Blood clotting in the brain can cause cognitive impairments and symptoms of anxiety, depression, and psychosis as neurons become stressed and damaged.

Dr. Counce had one patient who reported anxiety, erectile dysfunction, and visual impairment. Upon taking medication for his erectile dysfunction (vasodilator drugs that increase blood volume), his visual problems improved. Realizing that the patient had microclotting, Dr. Counce put him on aspirin and nattokinase and saw positive effects.

Spike protein can also directly harm the brain, possibly leading to a disturbance in brain activity and psychiatric problems.

It can also infiltrate immune cells, causing them to release histamine. Histamine can enter the brain and inflame and irritate the nerves.

Neuroinflammation has been linked to suicidality, and a type of anti-histamine medication has also been linked to reduced suicide.

Mr. Marsland has a postvaccine patient who only had physical symptoms. One day, the patient suddenly became suicidal.

After a painstaking conversation, Mr. Marsland figured out that the only change the patient made was switching from black tea to pu-erh tea.

"Pu-erh has incredibly high histamine content," Mr. Marsland explained. "So he stopped drinking it, and guess what, within two days, he was back to baseline.”

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8 November, 2023

What Made COVID-19 Vaccines "Safe and Effective"?

By Clare Pain

I am an Australian medical journalist with over a decade’s experience, who is also a UK citizen.

In September and October 2022 I tried to pitch this story raising concerns about the level of information given to the public when the COVID vaccines were rolled out in December 2020 and early 2021.

I submitted it sequentially to the conservative Sunday papers: The Sunday Telegraph, the Sunday Times, the Sunday Express, and the Sunday Mail.

Obviously, I did not expect that these world-famous newspapers would automatically publish anything I write! However, as a seasoned journalist, I do expect an acknowledgement and polite rejection of my pitch.

For all four newspapers there was no acknowledgement of my email, despite follow up. It was as if I had never sent it.

The aim of the story at that time was to inform people that, even at the beginning of the rollout, a reading of the UK Public Assessment Reports should have raised serious concerns about these new genetic vaccines. But it seems people were not ready for this information then.

But now the mood is changing. Many people know someone who has been injured by the vaccines, and we all know they do not stop transmission. Maybe they will be open to reading this story now?

Here's What I Wrote in 2022

The COVID-19 vaccines have been part of our lives for over 21 months, yet few people realise how different they are from vaccines we have used before.

During the first two years of the pandemic, I was a medical journalist writing for GPs and specialist doctors. I had not come across an mRNA vaccine and I had not heard of a DNA viral vector vaccine.

Nevertheless, like most of us, I was very relieved when the vaccines arrived in December 2020, because my dad was 87 and vulnerable.

Now, almost two years later, I think that the government should have been more transparent about the technology they were rolling out.

Some of us had Pfizer or Moderna injections, for instance, not knowing that a vaccine using mRNA (messenger ribonucleic acid) technology had never been approved for use in humans before COVID.

AstraZeneca (AZ) used a different technology, based on DNA (deoxyribonucleic acid). Only two similar vaccines for humans had been approved in the world prior to the AZ vaccine. These were in 2019 and 2020 for the rare and deadly disease, Ebola.

The three COVID injections differ from conventional vaccines because they use gene technology. A small piece of genetic code—in either mRNA or DNA form—is packaged and injected into our arms.

That genetic code tells our bodies to make the spike protein that protrudes from the virus particle. This protein is then recognised as foreign, and our bodies learn how to mount an immune response to it.

That should make us better prepared if we encounter a coronavirus bristling with spike proteins later in our lives.

So, why take this roundabout route of getting our bodies to make the spike protein instead of simply injecting a small amount of the protein as you might with a conventional vaccine?

It’s all about the ease and cost of vaccine production.

First, making DNA and mRNA is relatively easy and can be done quickly. It’s much simpler to do than making a conventional vaccine—that is normally done either by making an inactivated form of the virus or by isolating a protein from it.

Both viruses and proteins are delicate things that must be kept in a precise shape to be useful, so manipulating them to make a conventional vaccine can be tricky.

Unknown Unknowns?

It’s clear that genetic vaccines may be attractive to pharmaceutical companies because they provide a cheaper and more rapid route to market. And making vaccines to tackle new threats more quickly has obvious advantages for us all.
But, of course, we must be sure genetic vaccines are as safe and effective as conventional ones.

With any new technology, there may be new risks, some of which might be “unknown unknowns.”

The biochemistry of the human body is complicated, and a wise medical researcher expects surprises.

What’s more, people differ, so a drug or vaccine that has no side effects for most people may seriously harm a few. This is the reason safety trials include large numbers of participants.

Science is all about asking questions and then doing experiments to answer them. Here are just five of many questions about the genetic vaccines now being raised by people around the world.

First, how much spike protein do people make after a shot? And do different people make different amounts?

Second, how long is the DNA or mRNA active in our bodies? One thing we do know is that both Pfizer and Moderna use a synthetic mRNA that contains N1-methylpseudouridine. This makes the synthetic version last longer than normal mRNA.

Third, it would be nice to be sure that the genetic vaccine stays in the arm muscle and doesn’t reach other parts of the body. There could, for instance, be some organs in the body where making spike proteins would not be a good idea.

Fourth, could this new type of vaccine be harmful in ways that a normal vaccine would not be?

And fifth, when they were rolled out, did we have evidence that the vaccines stopped people from transmitting the virus to others? This is important because we were encouraged to get the injections so that we wouldn’t put other (vulnerable) people at risk.

Is the Devil in the Details?

To try to answer these questions I turned to the public assessment reports (PARs)—a weighty 352 pages in all!
These reports are produced by the UK's Medical and Healthcare Products Regulatory Agency (MHRA) when it approves a drug or vaccine, and they give the evidence behind the approval decision (the PAR for the Moderna vaccine was produced by the European Medicines Agency).

All three PARs have been publicly available on the UK government’s website since early in the rollout. Pfizer's was first published on Dec. 15, 2020, AstraZeneca's on Jan. 5, 2021, and Moderna's on Feb. 19, 2021.

None of the PARs show how much spike protein is made in a person's body or how long the DNA/mRNA remains active, so, unfortunately, we draw a blank in answering questions one and two.

The PARs did provide some information from animal “biodistribution” studies that suggest the vaccines may not just stay in the arm muscle.

We are told, for instance, that “low levels” of DNA from the AZ vaccine “were detectable in bone marrow, liver, lung and spleen” of laboratory mice (pdf).

For Moderna (pdf), no biodistribution studies were reported with the COVID vaccine itself, but a study of a similar vaccine was reported.

This showed that in rats, “low levels of mRNA could be detected in all examined tissues except the kidney.” We are told this included the liver, heart, lungs, testes, and brain and that higher levels were seen in the spleen and eye. We don’t know about ovaries because no female rats were tested.

A mouse study for the Pfizer vaccine suggested it reached the liver (pdf). We are told that information on “potential distribution” to other sites had been submitted to the MHRA, but it was not reported.

On the fourth question, whether the vaccines could do harm, we must remember that safety monitoring of people who were injected in the trials was carried out for just two months after the second dose. No long-term safety data was available.

No animal studies were done to see whether the mRNA/DNA in the vaccines could damage our genes (genotoxicity), according to the Pfizer and AZ documents.

For Moderna, a standard genotoxicity test of a similar mRNA vaccine in rats was done that showed raised levels of micronucleated red blood cells. This can be a signal of genotoxicity,but it can also be caused by other things. It was mentioned that genotoxicity data had been submitted for the COVID vaccine itself, but that did not seem to be reported.

Meanwhile, none of the genetic vaccines were tested to see whether they might increase the risk of cancer (carcinogenicity).

Indeed, for our latest approved “Autumn booster” vaccine, the Moderna bivalent Spikevax, the information leaflet for healthcare professionals (pdf) says “Carcinogenicity studies were not performed.”

By the way, the regulators mentioned a “theoretical risk” of Vaccine Associated Enhanced Disease (VAED) for all three vaccines. In other words, the MHRA and EMA were alert to the possibility that vaccination might make people get COVID more severely.

There was no evidence from the trials that this was occurring, but all three PARs say that the vaccine makers were instructed to keep monitoring for VAED.

Moving on to efficacy.

It’s important to be clear about what the word “effective” meant when the vaccines were rolled out.

Strictly, a vaccine can only be described as effective if it works in a real-world situation.

The original trial data could not show that the vaccines would be “effective” at promoting immunity in people such as the very sick and frail, people with immunodeficiencies, pregnant women, and young children, because people like this were not included.

Furthermore, the trials told us only that the vaccine was effective for two months against the strains of the virus that people encountered during 2020 (the year in which the trials were done). Anything else was a hope.

So when the government said they were effective, what exactly were the vaccines effective at doing? Stopping transmission of the virus; preventing people from getting COVID; or preventing severe disease and death?

Here’s what the trials showed.

If we amalgamate the data across the three vaccines, nearly 41,000 people in total were given two doses of a vaccine, while the same number received a placebo.

In the two groups—those vaccinated and those given a placebo—the number of people who developed symptomatic confirmed COVID was measured over a defined period. This window began one or two weeks after the person had received their second dose and ended two months after that dose.

While about 600 people in the placebo groups got COVID, only 100 did so in the vaccinated groups.

Symptomatic or confirmed COVID was defined slightly differently for each vaccine but boiled down to having one or two COVID symptoms (such as a temperature above a stated level, a new cough, loss of smell, etc.) plus a positive PCR test.

The Moderna trial data also indicated protection against severe COVID, with 30 of the 185 cases in the placebo group being classed as severe versus none of the 11 cases in the vaccinated group.

Could We Pass COVID on to Granny?

Turning now to the question of transmission, none of the trials were designed to test whether the vaccines could reduce the passing of the virus from one person to another. Indeed, the Pfizer PAR makes no mention of transmission.

The AstraZeneca PAR describes how rhesus macaque monkeys were vaccinated and then exposed to the virus. The vaccinated monkeys had a reduced viral load in their lungs but were still shedding the same amount of virus from their noses.

“These data support an interpretation that [the AZ vaccine] may not prevent infection nor transmission of SARS-CoV-2, but it may reduce illness,” the PAR authors wrote.

Later in the AZ document, it is said that data looking at the broadest definition of COVID infections in the human trials “suggests” a possible effect of the vaccine on transmission. However, the reasoning behind this statement is unclear, and more data was requested by the regulator.

Meanwhile, the Moderna PAR states that the effect of the vaccine on viral transmission cannot yet be determined, and “therefore the possibility for achieving herd immunity has not been demonstrated at the present time.”

So, it seems fair to say that when the vaccine rollout began and we bared our shoulders to protect granny, evidence that we would indeed protect her was scant.

A Trojan Horse?

Looking back to December 2020, when many of us rejoiced at the arrival of former Prime Minister Boris Johnson’s “scientific cavalry” that would rescue us from COVID-19, was it made clear to us and our doctors that we were rolling out a new genetic approach to vaccination? Or was that perhaps—keeping the equestrian theme—a Trojan horse?

To ask about this, I emailed the UK Health Security and Protection Agency. There has been no response to date, so I turned to the information currently provided on www.gov.uk .

In the government’s guidance for health professionals (pdf), I have been unable to find mention that the mRNA vaccines were a world first.

And for the rest of us, assuming the current consent forms (pdf) for adults have not been materially changed, there was no explanation of how the injections worked, nor was there an alert that a completely new approach to vaccination was being rolled out.

I wonder, now, whether our doctors and nurses knew enough to properly inform their patients about these genetic vaccines. And I wonder, too, how many people’s informed consent consisted of knowledge of just three words: “safe and effective.”

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7 November, 2023

Should vaccines be adjuvenated with alum?

For a long time vaccines were adjuvenated (made more effective) by adding aluminium salts to them. Eventually, however, sufficient concerns about the practice emerged for the practice to be dropped and Covid vaccines did not contain such adjuvants.

But was something lost by that? Might the Covid vaccines have worked better with adjuvants? The study below used mice to suggest an answer to that. They found that breakthrough infections were much worse with adjuvants.


While COVID-19 vaccines have generally remained effective in stopping more severe illness associated with SARS-CoV-2, the virus behind COVID-19, significant concerns emerge regarding vaccine-associated enhanced respiratory diseases (VAERD) post breakthrough infections. This means even though people get vaccinated, because the COVID-19 vaccines are not of the sterilizing type, they fail to protect against infection, especially over time, less intermittent boosters to bolster protection. Importantly, this recent animal study reveals spike protein subunit vaccines for SARS-CoV-2 induce VAERD in hamsters, where aluminum adjuvants promote a Th2-biased immune response, leading to increased type 2 pulmonary inflammation in animals with breakthrough infections.

Other research such as a study funded by China’s Beijing Science and Technology Plan and Emergency Key Program of Guangzhou Laboratory, found that both novel low-dose and high-dose adjuvanted inactivated SARS-CoV-2 vaccine with CpG and Alum induced high levels of specific IgG antibodies as well as neutralizing antibodies against SARS-CoV-2, and the continuous stability of high-level neutralizing antibody titers over time demonstrates long-lasting immunity.

The prominent study team was represented by Weishan Huang, Ph.D. Department of Pathobiological Sciences, School of Veterinary Medicine, Louisiana State University, as well as Cornell University’s Department of Microbiology and Immunology, College of Veterinary Medicine.

With a focus on virology and immunology, Huang’s lab studies the development and functions ­­of regulatory immunity and immune memory during vaccination, infections, and cancers.

With this infrastructure and expertise in place, plus support in the form of grants by the National Institutes of Health, and a “Big Idea Research Grant” from the Provost’s Fund at Louisiana State University, Huang and colleagues from Louisiana State University sought to gain a more comprehensive understanding of possible risks and the underlying mechanisms of VAERD designed a study involving the immunization of ACE2-humanized mice with SARS-CoV-2 Spike protein adjuvanted with aluminum and CpG-ODN.

After the immunization, the scientists challenged (intentionally infected) the mice with SARS-CoV-2 to establish the breakthrough condition.

What were the findings?

In this case, the authors report that their experimental vaccine A) elicited robust neutralizing antibody responses, B) reduced viral titers and C) enhanced host survival. Yet upon breakthrough infection, the vaccinated animals presented “severe pulmonary immunopathology, characterized by a significant perivascular infiltration of eosinophils and CD4+ T cells, along with increased expression of Th2/Th17 cytokines.”

Th2/Th17 cytokines are groups of signaling molecules produced by specific subsets of T-helped cells (Th cells) that play an important role in the immune system. These cytokines are involved in regulating responses and inflammation, and they are often associated with various immune reactions.

The study team conducted intracellular flow cytometric analysis (a technique used to identify cell types plus analyze signaling and functional responses within cell lines and heterogenous cell samples), revealing a systemic Th17 inflammatory response, especially intense in the subjects’ lungs.

The study authors report in the uploaded preprint server manuscript that the generated data demonstrate that aluminum/CpG adjuvants induce strong antibody and Th1-associated immunity against COVID-19 but also prime a robust Th2/Th17 inflammatory response, which may contribute to the rapid onset of T cell-mediated pulmonary immunopathology post breakthrough infection.

Food for Thought

There are no easy vaccine fixes for SARS-CoV-2, the virus behind COVID-19. These authors reaffirm that especially important principle. They declare in this yet-to-be peer-reviewed paper, “In conclusion, this research underscores the complexity of COVID-19 vaccination and the need for a comprehensive understanding of vaccine-induced immune responses. While vaccines remain a vital tool in combating pandemics, the potential for VAERD highlights the importance of ongoing research, surveillance, and careful vaccine development to achieve broad protection and maximal safety.”

Next Steps

Do these findings underscore the necessity for further research to unravel the complexities of VAERD in COVID-19? Does the study output point to the necessity to enhance vaccine formulations for broad protection and maximum safety? The study authors believe so.

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DeSantis: Overhaul National Childhood Vaccine Injury Act of 1986 & Impose More Oversight over FDA Staff

In a recent podcast interview, Florida Governor Ron DeSantis went on the record that he supports changing the current vaccine liability laws promulgated by the Reagan administration back in 1986. Those laws have helped spawn a robust vaccine sector targeting more diseases in the name of public health. Or, that’s what the public is told by a wealth-generating vaccine industry. What were at first, pragmatic measures meant to incentivize vaccine manufacturers, according to DeSantis, have turned into a vaccine development free-for-all, a race to generate the next blockbuster not as concerned with safety and quality but for economic return. The Food and Drug Administration (FDA) represents the world’s apex of drug and vaccine regulators. Yet about half of the agency’s budget now derives from Prescription Drug User Fees. This means that the FDA is highly dependent on the very industry it is tasked with regulating. Of the $5.9 billion budget, 45% derives from user fees, and 65% of the funding for human drug regulatory activity comes from user fees.

The National Childhood Vaccine Injury Act. of 1986, or “the Vaccine Act,” offers vaccine manufacturers a form of universal liability providing “no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death: (1) resulting from unavoidable side effects; or (2) solely due to the manufacturer's failure to provide direct warnings.”

While DeSantis acknowledges at the time the intention was needed to ensure the pharmaceutical companies needed incentives to invest in public health-related vaccines, the politician said on the Shannon Joy podcast, “I think what has happened now it is has shifted incentives actually away from safety.” He takes a controversial stance, markedly opposed to general sentiment from Washington that emphasizes the comprehensive rigor that goes into regulatory approvals.

The Florida Governor continued, “The incentives are now to produce anything you can get to the market and then make money off it because you aren’t going to be held accountable for the safety. So yes, I would support legislation to fix that because I think we want incentives that are going to be positive for the ultimate health outcome.”

While it’s most certainly true that the number of vaccines has exploded since the 1986 Act, it’s likely, not clear if the standards in regulatory oversight have declined generally, and if that is the case, that it’s due to this legislation.

Vaccine opponents believe regulators are “captured” by industry. But that’s a more complex, nuanced issue that DeSantis at least acknowledges.

On the problem of the intertwined nature of the pharmaceutical industry and the regulatory body in the U.S., DeSantis chimed in, “Of course, a lot of the people who work for the FDA end up going to work for Big Pharma after, so we are going to end the revolving door. We are going to put a grace period in there: five to ten years, whatever would be appropriate so that you can't just keep bouncing back and forth.”

Should the revolving door end? This doesn’t sound very pragmatic, given the real-world circumstances—constraints and realities on the ground. After all, an ongoing shortage of the talent needed to run regulatory bodies, industry, academic, and the growing nonprofit research machine, not to mention the private equity firms now investing in drug development, means that placing further constraints on this limited pool of labor likely would lead to a series of other more severe problems. Much legislation, while well-intentioned, often leads to other even worse problems.

Plus, this sounds like substantial federal regulatory oversight of the type that goes well above and beyond what standard Republican and Democrat politicians would be willing to back. Would that truly be a Republican priority should DeSantis be the winner? Or more political talking points to exploit animosity, fear, and anger due to COVID-19-related pandemic government overreach?

Perhaps what’s needed first is solid research into the problem. Have the regulatory standards declined since the 1986 Act? How could evidence be generated to prove that point? Some of the answers may lie in the real-world data.

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6 November, 2023

The Need for Uncensored Data and Debate on COVID

“Ithink we would have done everything differently,” California Governor Gavin Newsom recently told NBC, conceding that strong criticisms of his state’s strict COVID-19 lockdown policies were “legitimate” in hindsight.

Looking in the rear-view mirror, the strict COVID-19 lockdowns, pursued in California and other states, were indeed a disaster. But it was a collective public policy failure, as Newsom observed. Public officials have a responsibility to look back and revisit what they knew—or should have known—before they proposed or implemented the various lockdown policies recommended by federal officials. The often draconian social and economic measures that many state officials imposed, including extended school closures and business shutdowns, resulted in multiple costly consequences that will plague Americans for a long time.

That’s why congressional investigators should take a deeper dive into the rationale behind federal officials’ guidance on COVID-19 lockdowns. States, especially where the toughest restrictions were implemented, should follow suit. Such reviews could help lawmakers avoid ill-advised government overreach when the next pandemic comes along.

COVID Lockdown Data. Peer-reviewed work of an international team of researchers led by Dr. Steve Hanke, professor of economics at Johns Hopkins University, Did Lockdowns Work? The Verdict on COVID Restrictions, offers some good insight. A comprehensive literature review, the first study of its kind over a broad range of countries, by Hanke, Dr. Lars Jonung of Sweden’s Lund University, and Dr. Jonas Herby of the Center for Political Studies in Denmark, examined over 19,000 studies but focused on 22 relevant studies with actual mortality data. Their “meta-analysis” examined the specific relationship of mortality to various lockdown restrictions, including mandatory stay-at-home orders, business and school closures, and mask mandates, especially in the workplace.

Hanke and his colleagues examined the specific impact of certain government mandates exclusively on mortality. Among other findings, they concluded that stay-at-home orders reduced COVID mortality between 1.4 and 4.1 percent; business closures by 7.5 percent; school closures between 2.5 percent and 6.2 percent; and mask mandates, particularly in the workplace, by 18.7 percent.

Looking at the aggregate impact of these restrictions across Europe and the United States, Hanke and colleagues found that “...lockdowns in the Spring of 2020 in Europe resulted in 6000 to 23,000 deaths avoided. To put those numbers in to context, during an average flu season, approximately 72,000 are recorded in Europe. Our results made clear that lockdowns had negligible public health effects when measured by mortality.”

COVID Masking Data. In a 2023 study, a team of researchers publishing in the Cochrane Review conducted the most comprehensive literature review (78 studies) on masking to date and concluded: “There is uncertainty about the effects of face masks. The low to moderate certainty of evidence means our confidence in the effect estimate is limited and the true effect may be different from the observed estimate of the effect. The pooled results of RCTs (Random Controlled Trials) did not show a clear reduction in respiratory viral infection with the with the use of medical /surgical masks.” Random controlled trials are the “gold standard” of academic research.

The Cochrane researchers did note that there is a further need for “large, well -designed” studies in multiple setting and populations, as well as levels of “adherence,” to get a better understanding of the effectiveness of masking. Hanke and his colleagues agree with the need for future research in this specific area.

The Swedish Experience. It is particularly noteworthy that officials in Sweden followed far less restrictive policies than European and American officials. They emphasized public information and voluntary compliance with public health recommendations, notably social distancing. Writing in The Frontiers of Public Health (2023), researchers recently reported: “Existing official statistics at both the European and global levels regarding total COVID-19 associated and excess overall mortality rates suggest that Sweden was less affected than most comparable countries that implemented stricter lockdown measures.”

Put into broader context, Hanke and colleagues observe, “Social distancing works. If you keep distance from others, your risk of being infected with a communicable disease is reduced. However, that fact that social distancing works does not imply that compulsory non-pharmaceutical interventions (NPIs), commonly known as ‘lockdowns—policies that restrict internal movement, close schools and businesses, ban international travel and/or other activities—work.”

Censorship of Science. An academic consensus on the impact of lockdowns does not, however, exist. For example, the British Royal Society published a 2023 study that concludes that the lockdowns did indeed contain the viral contagion and reduce mortality. Hanke and colleagues dispute the Royal Society conclusions because of its methodological flaws, specifically lumping together the effects of government mandates and voluntary compliance.

Previously, Hanke and colleagues published the methodological protocol for their research project in July 2021 in the Social Science Research Network(SSRN), a prominent academic platform for research papers. On March 2022, the SSRN published a critique of the paper, but in August 2023 refused to publish a reply by Hanke and his colleagues.

Because academic freedom is essential to the advancement of science, censoring or “deplatforming” academic debate is obviously unacceptable, especially in public health, where the safety of the public is so often dependent on the quality of academic research. Congress has a broad agenda for COVID-19 oversight. It should not overlook the consequences of censorship or suppression of scientific dissent.

There is rarely a binary choice between protecting public health and preserving some semblance of social and economic normalcy. Public health is not only threatened by viral contagion, but also by draconian social and economic lockdowns.

As Dr. Daniel Johnson, former president of the American Medical Association, counseled at the inception of the pandemic: The tough policy job is to protect lives and livelihoods, a prudential balancing that can preserve public health in a holistic fashion.

Too often that has not happened. In his book The Contagion Next Time, Dr. Sandro Galea, Dean of the Boston University School of Public Health, recounts his own research work on the effect of lockdowns on public health: “We found that lockdowns and socially restrictive policies can undermine health in both the short and long terms, creating particular challenges for vulnerable populations. Our work suggested that the harmful consequences of such policies should be considered in decision-making about pandemic response.”

Today, few dispute the negative consequences of the COVID-19 lockdown policies: major economic disruption and massive unemployment; the closure of hundreds of thousands of businesses and the loss of small businesses, including minority businesses; unprecedented increases in federal deficit spending and debt; severe damage to childhood education; aggravated economic and educational inequality; social isolation and increased mental health problems; and, of course, loss of personal freedom.

Personally, Dr. Galea leans Left, but as a research scientist he rightly emphasizes that sound public health policy is not, and should not be, an ideological issue. Progress is dependent upon competent assessment of the evidence, open scientific debate and sound data—all of it. Uncensored.

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More Than Nine in 10 Americans Say ‘No Thanks’ to Latest COVID-19 Booster Shot

In mid-September, the Centers for Disease Control and Prevention (CDC) issued a press release recommending “everyone 6 months and older get an updated COVID-19 vaccine to protect against the potentially serious outcomes of COVID-19 illness this fall and winter.”

Suffice to say, the CDC’s recommendation has fallen on deaf ears. To date, only 7 percent of U.S. adults and 2 percent of children have followed the CDC’s suggestion. In fact, the rate of Americans receiving the latest COVID-19 booster is so low that Dr. Camille Kotton of Harvard Medical School said the situation is “abysmal.”

Nevertheless, CDC Director Mandy Cohen remains unphased, recently telling Politico, “I think we’re on track. Would I love to see more? Of course, that’s my job as CDC director is to want more.”

Actually, Cohen’s job is to protect the health and wellness of the American people; not the bottom line of Pfizer and Moderna.

The American people are obviously skeptical about receiving yet another COVID-19 booster, which makes sense given the doublespeak, disturbing side effects, and lack of efficacy regarding the vaccine and boosters over the past few years.

To begin with, the CDC lost credibility when it changed the definition of “vaccine” and “vaccination” on its website a few months after the initial rollout.

Before September 1, 2021, the CDC defined “vaccine” as: “A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.” However, the CDC now defines “vaccine” as: “A preparation that is used to stimulate the body’s immune response against diseases.”

The CDC played semantics with the definition of “vaccination” as well, changing the definition from, “The act of introducing a vaccine into the body to produce immunity to a specific disease” to, “The act of introducing a vaccine into the body to produce protection from a specific disease.”

“Immunity” and “protection” are not synonyms; they have different meanings.

It is also more than likely that most Americans have trepidation regarding the latest booster shot based on the fact that there have been several side effects linked to the initial round of shots and subsequent boosters.

In 2022, the University of Arizona Mel and Enid Zuckerman College of Public Health released a study titled “Understanding low bivalent COVID-19 booster uptake among US adults,” which found that 31.5 percent of respondents said they chose not to receive a booster due to concerns about vaccine side effects and 23.4 percent cited concern about booster safety.

These concerns are warranted, considering the CDC acknowledges that myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) have been linked to “adolescents and young adult males within several days after mRNA COVID-19 vaccination.”

In early 2023, the National Institutes of Health (NIH) released a study that found, “Various cases of thrombosis have been reported as adverse reactions after vaccination with COVID-19 vaccines.” The NIH study also found “a significant increase in the incidence rate” of “pulmonary embolism following vaccination.”

Worse yet, the Vaccine Adverse Effect Reporting System (VAERS) reported 4,812 deaths, 4,996 permanent disabilities, and 21,440 hospitalizations from COVID-19 vaccines as of June 25, 2021.

As most Americans are well aware, the federal government even went so far as to grant a blanket liability shield for the makers of the COVID-19 vaccines under the Public Readiness and Emergency Preparedness Act of 2020.

What’s more, why would Americans take an experimental vaccine that has been shown to produce adverse side effects when the so-called vaccines do not prevent them from getting or transmitting COVID-19?

There are countless examples of high-ranking government officials, such as Dr. Anthony Fauci, who have received numerous boosters yet still became infected with COVID-19. Moreover, studies show that the original COVID-19 shot and the multiple boosters that have been rolled out over the past three years “decline in effectiveness” shortly after they are administered.

And, considering the fact that COVID-19 poses little to no threat among the young and healthy, why in the world would the CDC promote an experimental vaccine for infants?

The good news is that Americans are continuing to get vaccines for diseases such as measles, mumps, the flu, and other preventable illnesses. This shows that there is not a general distaste for vaccines as a whole among the American population. However, given the shoddy track record of a set of vaccines that do not meet the classical definition of vaccine, produce dire side effects, and do not even work as intended, it makes perfect sense that only a sliver of the population is willing to keep getting boosted.

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5 November, 2023

New Covid variant HV.1 variant becomes dominant as America's booster vaccine program lags

A new coronavirus variant is spreading across the United States, but experts have urged people not to be alarmed.

The mutant strain — dubbed HV.1 — is a mutation on the EG.5 variant which sparked concern earlier this year.

It is now dominant in the US behind 25 percent of cases, with experts saying it is more transmissible than other variants. There is no sign it is more likely to cause severe disease.

Experts are not raising the alarm over the mutant strain, however, saying there will 'always be new variants' as Covid continues to spread and mutate.

Concerns are being raised over America's slow booster program, however, with uptake branded 'abysmal' this weekend with less than three percent of Americans having come forward a month into the rollout.

Covid cases and hospitalizations are currently trending downward and deaths are flatlining, although experts warn cold weather leading people to spend more time indoors could lead to an uptick in cases.

Dr Amesh Adalja, an infectious diseases expert at Johns Hopkins University, told WION: 'It is important to recognize that there will always be new variants of SARS-CoV-2.

'[This is] just as there are with any other endemic respiratory virus and most will not be of concern to anyone.'

Dr Ross Kedl, an immunologist at the University of Colorado Anschutz School of Medicine, added: 'All that people know at this point is that it's increasing in representation.

Doctors urge elderly adults to get Covid, flu and RSV vaccines this winter

Doctors have urged older adults to roll up their sleeves for three different vaccines this fall.

'There's no evidence that it's more severe.'

And Dr William Schaffner, an infectious diseases expert at Vanderbilt University School of Medicine in Tennessee, told Prevention: 'I don't think people should be very concerned about this.

'Some of the symptoms recorded have been cough, fatigue, congestion and a runny nose. That sounds pretty much like the common cold.'

Scientists say Covid will continue to mutate and create new variants as new cases arise.

But they add that there is little need to fixate on each new strain that comes along because most will not raise the risk of serious disease.

HV.1 was first detected in late July in Costa Rica, according to Covid variant tracking website outbreak.info.

It has now spread to more than 41 countries — including the UK, Canada and Israel — and a total of 4,397 cases have been detected, mostly in the United States.

This is likely to be a massive underestimate, however, because many cases are not checked for variants.

The mutant strain was spotted in the US back in July and has been accounting for an ever higher proportion of cases since.

By the end of August it was behind three percent of cases, according to figures from the Centers for Disease Control and Prevention (CDC).

By the final week of September, however, it was behind 12 percent of all Covid cases with latest estimates for this month estimating it is now behind one in four infections.

California — America's most populous state — has the most cases at 115 recorded, followed by New York — a 'bellwether' state — at 70 cases.

The mutant strain has several mutations on its spike protein which experts say may make it better able to dodge immunity and infect cells.

There is no sign that it is causing different symptoms at present either, with doctors likening its symptoms — including a cough and runny nose — to the common cold.

The US is currently rolling out an updated Covid booster vaccine which has been made available to everyone over the age of six months. Top advisers say, however, that only those over 65 years old need to get inoculated.

The vaccine is based on the XBB.1.5 Covid variant — which was dominant this summer — with experts saying HV.1 is a 'grandchild' of this strain.

They suggest that the vaccine will still work well against severe disease caused by HV.1 because it only has a few further mutations.

It comes as Covid cases and hospitalizations continue to trend downward nationwide.

Latest CDC data showed the positivity rate — proportion of tests that detected the virus — was down to 8.7 percent in the week to October 21, compared to 9.4 percent in the prior week.

There were also 13,036 Covid patients hospitalized in the week to October 21, the latest available, down 4.6 percent on the 13,652 at the same time last week.

For comparison, at the peak over the last two years there were 145,636 Covid patients in hospitals on January 8, 2022.

Covid deaths are currently flatlining at 1,347 being recorded every week, with preliminary data suggesting they may soon start to fall.

Some experts warn, however, indicators will start to trend upward in the coming weeks because cooler weather will lead to more people staying indoors.

There are also gatherings for the holidays upcoming, including Thanksgiving and Christmas, which will lead to different generations coming together — potentially fueling the spread of Covid.

Dr Kelly Oakeson, chief scientist at the Utah Department of Health, told Deseret News: 'If this was happening in the summertime, it might have less of an impact on everything.

'But now that it's happening in the fall/winter, people are indoors, it's getting colder outside, there's more holidays.

'You're probably going to see an increase in cases for sure. Is that driven by HV.1? Is that driven solely by the seasonality, what time of year it is?

'No, it's probably a combination of all of those things... we've seen this now, year after year.'

Concerns have also been raised over the Covid variant JN.1, which is a mutated version of the strain BA.2.86, or 'Pirola', that scientists warned could spark a new wave of infections.

There have been 51 cases reported worldwide to date across 11 countries including the United States, the UK and Germany.

Some scientists fear this strain is more transmissible than others and could spark a new wave of infections.

Dr Oakeson described this mutant strain as 'alarming'.

'We're definitely watching it,' she said.

'I'm not sure I'm at the same level fo concern I was with BA.2.86 just because this one is a descendent of those and we didn't see that take off in the US like it did in other parts of the world.'

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Government’s Overreach During COVID-19 Is a Likely Contributor to Waning Confidence in Vaccination

The University of Pennsylvania Annenberg Public Policy Center conducted a survey October 5-12, collecting answers from 1,500+ adults across America, and the results in some ways, are not surprising. For example, the number of Americans who believe that generally, Food and Drug Administration (FDA) approved vaccines are safe declined to 71% from the last survey number of 77% done April 2021. Are the numbers of American adults that don’t trust the FDA’s judgment growing? You bet. Now, 16% up from 9% in 2021, don’t believe approved vaccines are safe.

What’s behind this growing distrust of government, particularly in the realm of biomedical and health-related research?

The survey also asked questions about the antiparasitic and quite controversial drug ivermectin. Approved as a parasitic drug in the U.S., the FDA went into an information war against doctors that were prescribing the drug off-label for COVID-19. The agency emphasizes its use primarily for animals, but that’s not really true. It's used as much for humans when looking at programs such as the now 35-year Mectizan program where literally over a billion courses have been administered in tropical Africa to help humans fight off parasite-borne disease.

This media found evidence of improper behavior and of course, in a lawsuit a judicial decision concurred.

The number that believes it's safer to get the vaccines versus succumbing to COVID-19 infection has dropped to lower than two-thirds, down from 77% in November 2021.

But the government, in this case the nation’s public health agency, the Centers for Disease Control and Prevention (CDC), tells us the best way to prevent the disease from causing hospitalizations and deaths is to get the COVID-19 vaccine. But does the government legitimately address many concerns we have about safety signals, for example? Do they help us come up with the individual risk-benefit analysis we need?

So, it's a confusing time. In this case, to have any legitimacy from a broader corporate/government ecosystem, a news outlet must declare exactly what government authorities declare as the exact truth: There can be no deviation. That’s why all trade press following the world of pharmaceutical research such as STAT followed this party line, not daring to question any underlying elements of the formal promulgated narratives.

For example, a news platform seeking full credibility must declare, therefore, that the FDA approved antiparasitic ivermectin is not a safe and effective way for treating COVID-19. Of course, when looked at from a narrow lens of the established narrative, this is of course, true--under the regulatory apparatus empowered for making such calls in the United States.

But during the pandemic, especially earlier in the crisis, ivermectin was used extensively in dozens of nations, often as part of a combination regimen including doxycycline and zinc. C19ivm.org has tracked the number of ivermectin studies involving COVID-19 during the pandemic. While the administrators remain anonymous, which TrialSite suggests was a mistake (they likely did so to keep their employment in academic medical centers or industry), the data is accurate in every case we have checked.

To date, the website reports over 99 studies involving 1,089 scientists, 137,255 patients in 28 counties that generated quite a bit of data showing that the regimen can statistically lower risk for mortality, ventilation, ICU, hospitalization, recovery cases and viral clearance. See the link.

And we can emphatically declare this media, TrialSite, was the first one to systematically track the study output of this drug in the context of the novel coronavirus, plus real-world usage during the pandemic. We have had prominent advocates for use of this drug such as Dr. Pierre Kory, co-founder of the Front Line COVID Critical Care (FLCCC) Alliance, tell us directly that we changed the course of the pandemic for the better. He and many others first learned about its use around the world on TrialSite News.

Of course, a handful of high-profile studies failed to show efficacy, and not surprisingly, those outcomes were fully embraced by mainstream media big time. We have had academic medical researchers look into those studies, and in a few of them raise serious questions which have not been answered.

We certainly sensed an agenda during the pandemic. The government exhibited a clear bias toward waiting for the vaccines and any branded pharmaceutical options. But from March 2020, to essentially the end of the year, there was nothing else. Doctors had to do something on the front lines.

While we cannot declare that across-the-board ivermectin represents a safe and effective treatment for COVID-19, we also cannot just make blanket statements that this would be false and misleading because of government agency or industry pressure.

The way the survey folks will understand it, even discussing ivermectin in the positive would be considered misinformation. But this is not true because there is some level of evidence that it has helped (Remember Uttar Pradesh as a prominent one). Real world scenarios were not documented in study form, and many of the ivermectin studies done around the world were not that well designed. So, we cannot be certain. But we remain open, like true scientists, to the unfolding stream of data. That’s how science is supposed to work.

We reported other glaring examples of industry bias during the pandemic such as with the ICAM protocol at a major Florida-based health system.

What appeared to be a lifesaving protocol involving blood thinners and steroids was quickly discarded after TrialSite reported the topic, gaining hundreds of thousands of views at that time. But due to an apparent contract Pfizer had the health system sign, the health system was forbidden from coming up with a repurposed regimen for COVID-19. It doesn’t matter if lives are saved or not. That policy was enforced by an industry adhesion-like contract, in a pandemic, designed to maximize profits in the worst emergency.

This is absolutely disgusting behavior, and another reason why trust is waning in our health-focused governing institutions. And frankly, while biased on this topic, I think it makes a case for the importance of TrialSite, a unique media and information service platform committed to translating complex biomedical and health research for broader audiences.

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3 November, 2023


Some Scientists, Journals Pose 'Potential Threats to Vaccine Confidence', says CDC

Scientists and journals that conduct and publish certain research pose a problem for the federal government's vaccination campaigns that should be addressed, U.S. Centers for Disease Control and Prevention (CDC) officials wrote in newly reviewed emails.

Colin Bernatzky, a public health analyst with the CDC's Immunization Services Division, in one of the missives flagged a paper from scientists in the United States and several other countries that analyzed the effects of repeated COVID-19 vaccination.

Vladimir Uversky, a molecular medicine expert in Florida, and his co-authors noted that experiments have found multiple doses of the Pfizer and Moderna COVID-19 vaccines lead to higher levels of antibodies called IgG4, making the immune system more susceptible.

"COVID-19 epidemiological studies cited in our work plus the failure of HIV, Malaria, and Pertussis vaccines constitute irrefutable evidence demonstrating that an increase in IgG4 levels impairs immune responses," Alberto Rubio Casillas, one of the co-authors, told The Epoch Times.

The paper was published following peer-review by Vaccines.

Mr. Bernatzky took issue with the paper and The Epoch Times' coverage of it despite acknowledging he wasn't sure about its veracity.

"At the very least, it seems like there's some editorial recklessness going on, especially since the net result is that this research is being viewed as legitimate and is circulating widely. (And if the research is in fact legitimate, it should be on CDC's radar)," he wrote.

About a week later, on July 7, Mr. Bernatzky provided colleagues with more information on what he described as "potential threats to vaccine confidence posed by select scientific journals and publishers."

The paper from Mr. Uversky and Mr. Casillas "has been accumulating a massive amount of attention," Mr. Bernatzky said, with a high attention score that was "undoubtedly driven" mostly by The Epoch Times article.

"Unfortunately, the Uversky paper is part of a wider pattern of academic journals conferring legitimacy to anti-vaccine claims through their willingness to publish low-quality work (e.g., reviews with lots of conjecture rather than original research) as well as their apparant reluctance to issue retractions or disclaimers when these issues are called to their attention," he added.

The CDC official noted that the paper was cited by Massachusetts Institute of Technology research scientist Stephanie Seneff and her co-authors in response to criticism of a paper they wrote that outlined concerns with how the vaccines impact the immune system.

The author list of that paper "turns out to be ... a squad of vaccine skeptics that includes Peter McCullough," Mr. Bernatzky said, referring to a U.S.-based cardiologist that has expressed concerns about the safety of the COVID-19 vaccines, "with a track record for promoting ideas about autism, vaccines, Roundup, etc."

Mr. Bernatzky suggested the "systemic issues" with certain scientists and publishers should be addressed, describing the matter as "complicated." He pointed out that a new paper by Dr. McCullough was published as a preprint by The Lancet but quickly removed, spurring criticism.

The email was circulated widely within the CDC, according to other missives obtained by The Epoch Times, with officials focusing on the paper by Mr. Uversky and Mr. Casillas and its conclusions.

"Apparently it's gone viral," Sarah Meyer, another CDC official, said while sharing the email with a colleague. She said she also sent the concerns to the CDC's Coronavirus and Other Respiratory Viruses Division.

Karen Broder, the colleague, forwarded the email to Drs. Tom Shimabukuro and John Su, two top CDC vaccine safety officials.
None of the CDC officials, including Mr. Bernatzky, responded to inquiries. A CDC spokesman declined to comment.

Mr. Bernatzky has sociology degrees and has written that the "anti-vaccine movement is arguably one of the more concerning social movements to have surfaced during the first two decades of the current century." He has also alleged that support for former President Donald Trump is linked to "hate material."

The CDC regularly publishes and promotes papers that have not been peer-reviewed in its quasi-journal, Morbidity and Mortality Weekly Report. In the full set of emails, which were obtained through the Freedom of Information Act, officials on multiple occasions used those papers to craft guidance to the public on COVID-19 vaccine safety.+

The journals Vaccines and Food and Chemical Toxicology, which the CDC singled out for criticism, did not return requests for comment.

Mr. Casillas, a doctor at Autlan Regional Hospital in Mexico, told The Epoch Times in an email that the CDC never contacted him and said the paper he helped put together "must be read and interpreted for what it is: a hypothesis."

"In our work, we developed a series of hypotheses about the possible consequences of a high concentration of IgG4 antibodies induced by repeated mRNA vaccination. It is important that health experts and the general public understand that we never categorically stated that, for example, such antibodies induce cancer. If you read our work, you will notice that throughout the article we used words that denote the nature of a hypothesis," he said.
Mr. Casillas said the CDC's criticism was unwarranted.

"Each of our proposals is based on previous research. They must be evaluated experimentally to be confirmed or refuted. It is the only way science can advance to obtain safer vaccines. We are aware that we may be wrong, but we do not accept that our work is criticized based solely on opinions," he wrote.

Ms. Seneff said that the paper from Mr. Casillas and his co-authors was "a very thorough review that reveals the complexity in the immune system's reaction to antigenic exposures, and examines the potential adverse consequences of the experimentally observed high levels of IgG4 antibodies induced by repeated vaccination with the SARS-CoV-2 mRNA vaccines."

She said that her view on the research into the IgG4 antibodies is that the antibodies are not protective and block other, protective antibodies. She also sees the elevated levels of IgG4 antibodies as linked to serious problems, including severe autoimmune disease.

"This paper is seminal, and it is not surprising that it has gone viral, due to its deep analysis of the significance of elevated IgG4 following mRNA booster shots," Ms. Seneff told The Epoch Times in an email. "I doubt that the mainstream position that these vaccines are safe and effective can survive much longer, even as they continue with aggressive efforts to retract the comprehensive review papers that reveal the true colors of these experimental therapies."

Dr. McCullough told The Epoch Times via email that the CDC and other health agencies would be better served holding open meetings "instead of emailing gossip between each other."

If they held the meetings, he said, officials "can hear directly from the nation's experts who learned how to treat acute ambulatory COVID-19 and who are now handling the tsunami of patients with COVID-19 vaccine injuries, disabilities, and deaths."

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Lack of Informed Consent and Disabling Stroke after Pfizer mRNA Vaccination

It has been difficult for COVID-19 vaccinated Americans to process what has happened to their bodies. Public testimony by mRNA vaccine victims has been a relatable way of try to understand what has happened to our citizenry with a mass, indiscriminate COVID-19 vaccination campaign that failed on the informed consent process as reports of side effects poured into vaccine data systems.

On October 20, 2023, The Novel Coronavirus Southwestern Intergovernmental Committee convened a hearing to review new developments on the COVID-19 vaccine safety debacle and broader issues of informed consent which was highlighted by these words from Committee Chair, Senator Janae Shamp, who is a registered nurse. Be sure to listen to her opening remarks and play to through to heartwrenching story of media executive Ms Calli Varner.

Calli Varner, age 37, with Pfizer mRNA stroke with left face and body paralyzed. She was airlifted to a tertiary center and treated with thrombolytics in 2021

The 37 year-old woman gave her vignette of suffering a stroke after Pfizer, mRNA COVID-19 vaccination. This stroke was so serious she had to be airlifted to a tertiary center and receive thrombolytics (clot-busting drugs). Because the mRNA installed the genetic code for the Wuhan Spike protein, she then had the development of premature menopause, auto-immunity, and a rapidly growing thyroid nodule.

I told the committee and the audience in attendance, this could not have all been attributed to 15 years of oral contraceptive use as Calli’s doctors claimed. I cited medical literature that clearly demonstrate the COVID-19 vaccines cause stroke and doctors are willfully blind to the damaging effects of the vaccines.

LTC Dr. Pete Chambers stated that disabling vaccine injuries are happening to our soldiers. He implored people to have courage, speak out, and “stand in the gap” to warn others. That will be the only way to prevent more causalities.

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2 November, 2023

European Regulator Confirms Pfizer Did Not Highlight DNA Sequence in COVID-19 Vaccine

Pfizer did not highlight a DNA sequence in its COVID-19 vaccine, a European regulator has confirmed.

"While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorization application for Comirnaty, the applicant did not specifically highlight the SV40 sequence," the European Medicines Agency (EMA) told The Epoch Times in an email.

The email came after Health Canada told The Epoch Times it expects sponsors to identify sequences such as the Simian Virus 40 (SV40) DNA enhancer but that Pfizer did not.

Pfizer and its partner, BioNTech, have not responded to requests for comment.

Pfizer did not highlight the inclusion of the enhancer in its vaccine because "it was considered to be a non-functional part of the plasmid," EMA said. "They have since clarified this information in response to questions raised by EMA."

The EMA said parts of the SV40 sequence are "commonly present in plasmids used for manufacturing of biological active substances," but neither authorities nor Pfizer have been able to say why the sequence was made part of the Pfizer shot.

Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer, told The Epoch Times "there is no reason" to include the sequence. He has urged U.S. regulators to recall the vaccine, but the regulators have declined.

Contested Claims

According to the EMA, the DNA sequences, including the SV40 sequence, are "broken down and removed" during the manufacturing process. "Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled," the EMA claimed.

The agency did not provide any evidence to support the claim.

"The best independent estimates are 100-200B fragments of the plasmid exist in each dose," Kevin McKernan a microbiologist who first identified the sequence in the vaccine, told The Epoch Times in an email. "The EMA has offered no scientific evidence to make such a claim other than 'Trust our non-peer reviewed heavily redacted failure in transparency.'"

An EMA spokesperson said earlier this year that there was "no evidence to indicate the presence of SV40 ... in the formulation of COVID-19 vaccines."

The EMA is now acknowledging that statement was not correct.

But the regulator said it "has seen no evidence of an association between mRNA vaccines and adverse events that could be linked to the presence of DNA material, nor are we aware of any scientific evidence showing that the very small amounts of residual DNA that may be present in vaccine batches could integrate into the DNA of vaccinated individuals."

It also said, "we have not seen any reliable evidence of residual DNA exceeding approved/safe levels for" the Pfizer vaccine.

Dr. Malone said that the standards they're citing were not designed for the Pfizer and Moderna vaccines, which use modified messenger ribonucleic acid (RNA) technology.

"The safe threshold in the presence of these delivery complexes is something that must be established experimentally by performing genotoxicity studies," Dr. Malone said. "To say that just because we haven't detected it, or it's below the level that we normally accept with, say a flu vaccine, is completely irrelevant."

Fragments Act as Mutagens?

Some scientists say they're concerned because the DNA fragments could act as mutagens, or change the DNA sequence in a gene, even when taking into account how the SV40 sequence in the vaccine is not the cancer-causing large T antigen.
"The thing is that the smaller pieces actually could be very significant," David Wiseman, a former Johnson & Johnson scientist, told The Epoch Times. "They could actually get into your genome, potentially."

Mr. Wiseman was part of a team that recently detected levels of residual DNA in Pfizer's vaccine, as well as in Moderna's vaccine.

Patrick Provost, a professor in the Department of Microbiology, Infectious Diseases, and Immunology at the Faculty of Medicine at Laval University, told The Epoch Times that the danger of the SV40 enhancer being present in the vaccine is its possible integration into a cell's DNA genome.

"All it takes is a single integration at the wrong place in a single cell to initiate a cancerous process and kill a person," he said.

Responding to those concerns, the EMA said that "there is no scientific evidence that any of these SV40 fragments can act as insertional mutagens."

Dr. Malone said that was not true.

"Short DNA fragments and oligonucleotides are specifically used in modern biomedical research to experimentally alter the genomes of cells and embryos," he wrote in an email. "Such DNA fragments are well known to those skilled in the art to be useful for altering genomic information and genome integrity via both recombination and insertional mutagenesis."

Mr. McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project, noted that scientists have found that SV40 sequences are optimal for gene therapy and that one paper described a rate of insertional mutagenesis with transfection being as high as 7 percent of the modified cells.

"Given the EMA waived all genotoxicity studies, their statement is nothing more than complicit wishful thinking," Mr. McKernan said.

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FDA Medicare SafeRx Study—Elevated Risks of Stroke Detected from conjuction of COVID-19 & Influenza Vaccines

Thanks to funding from the SafeRx Project, a joint initiative of the Centers for Medicare & Medicaid Services and the Food and Drug Administration (FDA), a group of authors employed at the FDA (the Agency) and a government contractor called Acumen LLC recently completed a self-control case series (SCCS) study tapping into a vast Medicare database (SafeRx). The mission is to investigate any risks of ischemic stroke associated with the COVID-19 vaccine.

This study was prompted by a concern expressed January 2023, by both the FDA itself and the Centers for Disease Control and Prevention (CDC) for an increased risk of ischemic strokes in adults aged 65 years and up after receiving the COVID-19 vaccine (bivalent targeting BA.4/BA.5); plus, the prospect of such a possibility involving the COVID-19 vaccine and concomitant high-dose/adjuvanted influenza vaccine.

This presented analysis tapped into and analyzed data from the Medicare fee-for-service (FFS) population aged ?65 years. The agency-sponsored study team sought to estimate the risk of incident stroke following COVID-19 bivalent vaccines among Medicare beneficiaries. The study team evaluated stroke risk among age groups, following influenza vaccines, and following concomitant influenza and COVID-19 bivalent vaccine administration from August 31 to November 6, 2022.

While the primary analysis found no elevated risk, specific subgroup analyses identified elevated risk including A) increased risk for persons age 85 years and up for both non-hemorrhagic stroke (NHS)—another term for ischemic stroke, and transient ischemic attack (TIA) with the Pfizer bivalent COVID-19 bivalent vaccine as well as B) an increased risk for both NHS and TIA for those Medicare beneficiaries who received a concomitant COVID-19 bivalent vaccine and a high-dose/adjuvanted influenza vaccine (NHS with Pfizer and TIA Moderna).

Finally, C) the authors found upon completion of secondary analysis a small increased risk of NHS linked to the high-dose or adjuvanted influenza vaccines. While the FDA-sponsored investigation detected such elevated levels of risk, the authors remain steadfast as to the substantial benefits of vaccination, mindful of the risks associated with viral infection leading to an overall reaffirmation as to the safety of these medical products.

What’s the Concern?

The study authors herein address endpoints including the linking of the COVID-19 vaccine as well as influenza vaccine and ischemic stroke. Specifically identified are both the non-hemorrhagic stroke (NHS) and the transient ischemic attack (TIA).

An NHS or ischemic stroke is a type of stroke that occurs when blood flow to a part of the brain is blocked. This blockage can be caused by a blood clot or atherosclerosis, which is the narrowing and hardening of the arteries. Importantly, Ischemic or NHS are the most common type of stroke, accounting for over 80%.

A TIA is often called a “mini-stroke” and represents a medical condition that mimics the symptoms of a stroke but is temporary and does not cause permanent brain damage. These occur due to a brief interruption of blood flow to the brain.

A Robust Study

Led by agency veterans including Stephen Johnson, Ph.D., Director, Office of Biostatistics and Epidemiology, and Richard Forshee, Ph.D. Deputy Director Office of Biostatistics and Pharmacovigilance, the study team included vaccinated individuals’ data only, leaving them not subject to bias due to underreporting of vaccination status in the claims data. Also, Johnson, Forshee and colleagues claim they mitigated any misclassification bias by conducting medical record reviews of the claims-based NHS definition.

The study authors here report on numerous study strengths, such as a robust, large, representative Medicare database, with minimal beneficiary attrition, ensuring highly generalizable findings to the elderly U.S. population.

They also point to the ability of this self-controlled study design to adjust for time-invariant confounders such as health conditions, socio-economic status, and health-seeking behavior. Such factors can inherently bias a study, drawing from between-individual comparisons.

Results Summary

As reported in the preprint server medRxiv, a primary analysis failed to detect elevated stroke risk post-COVID-19 bivalent vaccination.

However, while slicing and dicing the data, including analyses involving subgroups, the study authors report that the cohort of ?85 year associated with a risk of non-hemorrhagic stroke “(NHS) (Incident Rate Ratio (IRR)=1.36, 95% CI 1.09 – 1.69 [1-21 days]) and NHS/ transient ischemic attack (TIA) (IRR=1.28, 95% CI 1.08 – 1.52 [1-21 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5.”

When analyzing the data associated with the Medicare beneficiaries “that received a concomitant COVID-19 bivalent vaccine and a high-dose/adjuvanted influenza vaccine, an increased risk was observed for NHS (IRR=1.20, 95% CI 1.01 – 1.42 [22-42 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5 and for TIA (IRR=1.35, 95% CI 1.06 – 1.74 [1-21 days]) with mRNA-1273.222.”

The authors summarized that once completing their secondary analyses, they detected “a small increased risk of NHS following high-dose or adjuvanted influenza vaccines (IRR=1.09, 95% CI 1.02 – 1.17 [22-42 days]).”

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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1 November, 2023

Disastrous Covid vaccination campaign in Poland

Poland’s National Audit Office known as “NIK” has identified a substantial surplus of COVID -19 vaccines due to lack of demand. The nation had contracted for a full vaccination rate multiple times over, yet the national office reports vaccination rate decline. Consequently, 13.1 million doses were allowed to expire and then exposed by the end of 2022, representing PLN 1 billion (US$237.7 million). In total, Poland spent 13.9 billion PLN (US$3.3 billion) for this nation of only 37.7 million people. TrialSite reminds that this was one of the few media to cover Poland’s attempt to renegotiate the COVID-19 vaccine contract with Pfizer due to the impact of the Russian invasion of Ukraine. Pfizer refused to budge. What follows is what in reality is a damning report from the NIK as to what appears to be an unfolding scandal in the aftermath of the COVID-19 response.

The NIK reports the effort to sell, transfer or donate the COVID-19 vaccines to mitigate the effects of the excess. By 31 December 2022, the Governmental Strategic Reserves Agency (RARS) provided to other countries over PLN 27.6 million vaccine doses with an estimated value of PLN 1.4 billion or (US$333.3 million).

A Great & Deadly ‘Health Debt’ Caused by COVID-19 Response
The NIK has gone on record that the COVID-19 response caused significant disruptions in the healthcare provision. Above all, a great part of the healthcare system resources was “relocated” to control the epidemic. That resulted in shrinking access to treatment for a broad group of patients, diagnosed with diseases other than COVID-19. Hence, the so-called health debt was growing (that was a situation where the failure to provide a medical service may lead to a disease development or its worsening).

Excess Deaths during the Pandemic—Despite the Vaccine
In 2020-2021, an increased number of deaths was reported, as compared with the average of 2015?2019. In 2020, there were over 85 thousand more of them, including about 56.5 thousand deaths for reasons other than COVID-19. And in the first half of 2021, excess deaths against the number of deaths reported a year before totaled nearly 61 thousand. But what about the COVID-19 mass vaccination response?

In fact, the COVID-19 universal vaccination countermeasure was supposed to help prevent those negative phenomena. The vaccination did not succeed despite many claims that the vaccines saved millions of lives. TrialSite has reviewed dozens of observational studies suggesting that the vaccines have reduced morbidity and mortality but the nature of these studies are such that this does not prove causation.

NIK points out in line with the assumptions the vaccines should have ensured a “return to normal.” While also serving to “unblock” the healthcare system, particularly for patients with diseases other than COVID-19. As NIK declares in a recent media entry a direct objective in the COVID-19 National Vaccination System was:

to reduce the number of deaths and complications caused by the SARS-CoV-2, particularly in elderly persons,

to reduce the population “health debt” growth.

In 2021-2023, NIK conducted a range of ad hoc audits to establish if the objectives of the COVID-10 National Vaccination Programme were achieved and how. NIK carried out five audits to look into the Programme execution which cost about PLN 17 billion (US$4.05 billion).

The NIK audit revealed that:

The Minister of Health improperly estimated needs related to the purchase of an adequate number of COVID-19 vaccine doses (meaning that the Ministry ordered more doses than they needed to, which of course meant more taxpayer dollars to the pharmaceutical companies).

Poland did not have to enter into agreements - questioned by NIK - to purchase COVID-19 vaccines. The Minister of Health did not use that right.

Estimating demand

It needs to be underlined that no documents were presented showing how the number of vaccine doses, needed to satisfy the demand of Polish citizens, were estimated. There was no basis, no rationalization used to justify the large spend.

From May 2021, subsequent vaccine doses were contracted for, although Poland was bound with contracts enabling the vaccination of the entire population several times (109 million doses were contracted for at the end of April 2021).

Even assuming that every adult person in Poland, i.e., about 31 million individuals, received the third vaccine dose, the demand would be at the level of 93 million doses, i.e., lower than the number of doses contracted for before May 2021.

What did the Health Ministry Know?

Interestingly, what did the Polish Ministry of Health know about the COVID-19 pandemic that informed them to estimate such demand?

NIK reports that the Minister of Health formulated a thesis that prior to the execution of agreements indicated as improper, there were signals that vaccine boosters every 6 months are necessary to maintain the immunological response at an adequately high level. The thesis is not only unconfirmed by the evidence gathered in the audit but also it does not reflect the opinions of specialized EU institutions taking efforts to control the COVID-19 epidemic.

On 31 May 2021, the Minister of Health addressed the EU Health Commissioner concerning the vaccines purchased, pointing to the hazard of huge vaccine surplus in Europe and the need for coordinated cooperation to start talks with individual manufacturers to reduce the volumes of vaccine orders.

NIK emphasizes that the Health Ministry could have been culpable in questionably intentioned pursuits.

“It needs to be stressed that the Minister stated that the epidemiological situation is about to stabilise and pointed to the “hazard” of significant surpluses of the COVID-19 vaccines, only 11 days after signing the third agreement with Pfizer/BioNTech. It points to complete inconsistency of the Minister’s actions. According to NIK those measures were unreliable and wasteful.”

Poland’s COVID-19 Vax Contracts

As reported by the NIK, the Republic of Poland acquired the COVID-19 vaccines as part of the Agreement on the joint mechanism for the COVID-19 vaccine purchase.

The Agreement authorized the European Commission to negotiate and conclude vaccine purchase contracts, on behalf of the EU Member States. Remember, TrialSite reported on how at least part of the EC negotiation was done via private personal text between Pfizer’s CEO Albert Bourla and Commission President Ursula von der Leyen. The situation is so egregious that even the New York Times has sued the EC to get to the bottom of this possible scandal.

NIK reports that the EC as an entity took responsibility for the contracts’ content, including the principles of sharing vaccines among the EU Member States, the pool of vaccines covered by the contract, their prices and delivery dates.

The EC notified the EU member states of the former’s intention to sign the deal, and the reality that the latter had no rights to modify. NIK does inform that member states were notified that they did have the option to withdraw from the vaccine purchase contract. It was a take it or leave it deal.

NIK informs the world now that in the vaccine purchasing process two types of contracts were used: 1) contracts defining the right to purchase vaccine doses and 2) contracts defining the obligation to purchase them.

First, NIK notes that participating EU Member States were not obliged to sign that contract. With the second contractual model, the EC was obliged to inform the EU Member States about the intention to sign the contract with an obligation to purchase the vaccine doses, also defining its signing conditions. Again, Member States had not input.

NIK cites the problems with the contractual scheme as devised:

“All the contracts negatively evaluated by NIK were contracts defining the obligation to purchase COVID-19 vaccines. The states that did not agree to sign that contract or its conditions had 5 days to withdraw from the contract or declare a number of vaccines other than set out in the contract (the so-called “opt-out clause”).

NIK points out in their media entry “The opt-out clause required consent of partner states, in cooperation with the EC, to accept extra doses or to give away appurtenant doses.”

Outrageous: 117.6K Hazardous COVID-19 Vax Doses Administered to Polish Population

TrialSite also learned about this scandal in the recent NIK media piece, under the section “Supervision of the Chief Pharmaceutical Inspectorate (GIF) over the COVID-19 National Vaccination Programme.”

NIK added in its report the state’s negative evaluation supervision exercised by the Chief Pharmaceutical Inspector over the vaccine storage and distribution. The body responsible for pharmaceutical safety of the state, obliged with “special supervision”, did not know in which warehouses the vaccines were stored. This NIK reports, “The relevant information was taken from the media,” meaning the nation state had no control over the pharmaceutical product within its borders.

The Polish government found defects, yet as the government itself via the NIK reports, “GIF failed to take efforts to withdraw part of vaccines, in which some quality defects were found, also the ones posing a threat to health and life. In consequence, 117.6 thousand hazardous vaccine doses were administered to patients.”

Distribution and storage of vaccines

According to the NIK audits, 17 pharmaceutical warehouses were involved in the process of the COVID-19 vaccine distribution and storage. In the audited period, GIF carried out only two inspections in one of pharmaceutical warehouses taking part in the COVID-19 vaccine distribution.

“A lot of critical irregularities were identified, e.g., the vaccine storage conditions in special rooms or the vaccine transport from the Governmental Strategic Reserves Agency (RARS) were not registered. Also, the product safety was not provided during vaccine storage in that warehouse.”

NIK reports an alternative inspection targeting the same supply pointed to a scandalous takeaway: the “distribution process does not guarantee the safety of vaccines in terms of their quality maintenance.”

While European GIF inspectors were in fact, cognizant of the discovered irregularities adversely impacting COVID-19 vaccine safety and effectiveness, they carried out no inspections in the remaining 16 warehouses.

Consequently, Poland’s national auditor points out how the Minister of Health was culpable in an unfolding scheme:

“The Minister of Health had a significant, adverse impact on the effectiveness of actions taken by GIF. He made the following statement which was contrary to the applicable law:

the distribution of COVID-19 vaccines is not the trade in medicinal products, in the light of the Pharmaceutical Law Act, and hence,

the trade in vaccines may not be monitored via the Integrated System for Monitoring the Trade in Medicinal Products (ZSMOPL).”

Poland’s Minister of Health essentially blocked and tackled on behalf of what appears to be some kind of cabal consisting of EC bureaucrats, industry and perhaps other high placed persons. After all, thanks to the Minister’s efforts “pharmaceutical warehouses were freed from the obligation to report vaccine stock availability on a daily basis. Hence, GIF could not monitor the trade in those vaccines. The Inspectorate drew its knowledge about the COVID-19 vaccine warehouses from the media.” This unfolding scenario could only be considered an utter and complete scandal.

Risking Patient Safety

TrialSite reminds all that national health authorities exist to ensure the safety and welfare of the population, not to further endanger them.

Yet Poland’s own auditors report that “The decision of the Minister of Health not to use the monitoring system also had a negative impact on the safety of patients.”

The NIK informs the world:

“In two cases, GIF did not decide to withdraw from the market a series of vaccines, although the Inspectorate was aware of their quality defects. GIF could not withdraw the vaccines, because their distribution was not subject to the Pharmaceutical Law Act – in line with the interpretation of the Minister of Health, and so GIF had no legal grounds to withdraw them from the market. Besides, the Inspectorate did not know in which warehouses the defective vaccines were found.”

Vaccine quality defects

GIF received eight reports of actual or alleged quality defects of the COVID-19 vaccines, of which two were of significant importance, reports the NIK media entry.

Additional Notes

On 23 April 2021, the Chief Pharmaceutical Inspectorate received information in the Rapid Alert system from the European Medicines Agency, about a possible quality defect in one of the COVID-19 vaccine series, already used in Polish patients. The report dealt with the suspicion of a 2nd class defect, that is the one that could cause an illness or improper effects. GIF failed to issue a decision to withhold or withdraw that vaccine series from the market.

Meanwhile, in April 2022 the Federal Agency for Medicinal and Health Products in Belgium informed GIF about withdrawing that series from the market. Having received the report, GIF provided the relevant information to RARS, requesting the Agency to take action to identify distribution channels and inform recipients about the situation. The efforts were pointless, though, because the entire vaccine series was already administered to patients

the quality defect of the vaccine series was reported on 7 April 2022 by the Spanish Agency of Medicines and Medical Products (AEMPS).

In the second case The vaccine quality defect could pose a threat to patients’ health and life (1st class defect), which obliged GIF to withdraw the defective product from the market.

Summary of Breaches Risking Patient Health

Summarizing this scandal, NIK reports that “In both cases, GIF not only failed to withdraw the vaccine series from the market but also did not know where they can be found.”

Having received the report, information was passed on to RARS with a request to identify distribution channels and notify recipients about the situation. The Chief Pharmaceutical Inspector explained that in the light of the Minister of Health’s interpretation, the decision to withdraw the vaccine could not be issued for the product that is not in the market. That information was also provided to RARS.

The government's vaccination commissioner

The Chancellery of the Prime Minister and the Government Commissioner for the National Vaccination Programme dealt mainly with conducting campaigns encouraging Polish people to vaccinate. Over PLN 155 million (US$36.9 million) was spent in pursuit of that aim.

In parallel, no definitions were established to determine the effects of this initiative. How could they know what success is?

While the Commissioner according to the NIK had an obligation to analyze the relevant activated legislation as well as existing solutions as they relate to prophylactic vaccinations, the office failed to do so whatsoever. The Commissioner simply deferred to analyses promulgated by the Minister of Health. This is truly problematic.

The Commissioner was also obliged to prepare proposals of new legal solutions and initiatives in terms of the COVID-10 National Vaccination Programme.

“In view of the above, according to NIK, it was unjustified to appoint a vaccination commissioner, whose tasks could be discharged by the existing state bodies.”

In performing his tasks, particularly in drafting changes to resolutions on the National Vaccination Programme, the vaccination commissioner drew on the information and knowledge of the Government Analysis Centre, the Ministry of Health, the National Health Fund, the e-Health Centre, the Government Security Centre or the Chief Sanitary Inspector.

After the vaccination commissioner’s office was lifted, the Programme supervision was entrusted to the Minister of Health, meaning a complete takeover, clearing the pathway for the exact COVID-19 countermeasure execution NIK founds so many troubles with.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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