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 June, 2023. To access the backups in earlier years, click here
30 June, 2023
Note
I managed my seasonal virus better than I expected yesterday and managed to put up something interesting on all my blogs. I seem to be on track to do that today as well
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COVID-19 can cause brain cells to 'fuse'
Researchers at UQ have discovered viruses such as SARS-CoV-2 can cause brain cells to fuse, initiating malfunctions that lead to chronic neurological symptoms.
Professor Massimo Hilliard and Dr Ramon Martinez-Marmol from the Queensland Brain Institute have explored how viruses alter the function of the nervous system.
SARS-CoV-2, the virus that causes COVID-19, has been detected in the brains of people with ‘long COVID’ months after their initial infection.
“We discovered COVID-19 causes neurons to undergo a cell fusion process, which has not been seen before,” Professor Hilliard said.
“After neuronal infection with SARS-CoV-2, the spike S protein becomes present in neurons, and once neurons fuse, they don’t die.” They either start firing synchronously, or they stop functioning altogether.”
As an analogy, Professor Hilliard likened the role of neurons to that of wires connecting switches to the lights in a kitchen and a bathroom.
“Once fusion takes place, each switch either turns on both the kitchen and bathroom lights at the same time, or neither of them,” he said. “It’s bad news for the two independent circuits.”
The discovery offers a potential explanation for persistent neurological effects after a viral infection.
“In the current understanding of what happens when a virus enters the brain, there are two outcomes – either cell death or inflammation,” Dr Martinez-Marmol said. “But we’ve shown a third possible outcome, which is neuronal fusion.”
Dr Martinez-Marmol said numerous viruses cause cell fusion in other tissues, but also infect the nervous system and could be causing the same problem there.
“These viruses include HIV, rabies, Japanese encephalitis, measles, herpes simplex virus and Zika virus,” he said.
“Our research reveals a new mechanism for the neurological events that happen during a viral infection.
“This is potentially a major cause of neurological diseases and clinical symptoms that is still unexplored.”
The research was published in Science Advances.
https://stories.uq.edu.au/contact-magazine/2023/covid-19-can-cause-brain-cells-to-fuse/index.html
******************************************************Italian Bombshell—COVID-19 mRNA Vax Cardiac Problems ‘Not Uncommon’
Research led by Italian physician-scientists, including corresponding author Nino Cocco at Campus Bio-Medico University of Rome, Department of Cardiovascular Sciences and Francesco Pelliccia, Ph.D., Sapienza University of Rome shows mounting concerns associated with the COVID-19 mRNA vaccines.
Sharing that “several patients” complained of heart palpitations or even worse arrhythmic events after receiving an mRNA COVID-19 vaccine in their specific clinical practice, the research collective sought to undertake a literature review of post-COVID-19 vaccine heart rhythm disorders which turned up several instances of heart rhythm disorders after mRNA COVID-19 vaccination.
Noteworthy, biomedical researchers from both Italy and Switzerland found this problem with other vaccines in addition to the COVID-19 products. Importantly, in regard to COVID-19 mRNA vaccines, the study authors call out that serious adverse events are ‘not uncommon” and demand clinical and scientific attention now.
Context
While mass vaccination against SARS-CoV-2, the virus behind COVID-19, was considered collectively the best way to fight the COVID-19 pandemic, and generally, these products helped reduce cases of morbidity and mortality, the Italian-led team reports a troubling concern. They state that “side effects are being reported more frequently as more and more people around the world become treated.”
While the mRNA products are deemed “safe and effective” by regulatory bodies, the study team here emphasizes the importance of not underestimating “other side effects” in addition to the predominant risk of myopericarditis.
Key findings
Reporting on case series of patients affected by cardiac arrhythmias post-mRNA vaccine from their own clinical practice, the Italian-led team evaluate the literature. Reviewing the official vigilance database, Dr. Coco and colleagues report that “heart rhythm disorders after COVID vaccination are not uncommon and deserve more clinical and scientific attention.”
This assessment represents a distinct change in direction as most physician-scientists continue to downplay the linkages between the COVID-19 mRNA vaccines and various cardiovascular and other disorders linked to the novel products.
While the study authors continue to support the use of mRNA technology, arguing in their paper published in the International Journal of Molecular Sciences that “the risk-benefit ratio” remains “clearly in favor of vaccination,” they posit that linked “heart rhythm disorders are not a negligible issue, and there are red flags in the literature about the risk of post-vaccination malignant arrhythmias in some predisposed patients.”
The authors raise questions about the impact of COVID-19 vaccines on heart conduction. They also review possible molecular pathways for the COVID-19 vaccines to impact cardiac electrophysiology and cause heart rhythm disorders.
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Super fit mother-of-two, 37, 'is left in chronic pain, bound to a wheelchair and forced to find a new home' after Covid jab
A mother-of-two claims she has been left in debilitating pain and now relies on a wheelchair to get around after receiving three doses of a Covid vaccine.
Mel Guevremont, 37, says she has gone from being a keen gym-goer, surfer, snowboarder and rock climber to barely being able to take a few steps around her home before her legs give out.
Ms Guevremont, from Sydney, claims her body has broken down and she has been forced to wear a neck brace since receiving her third Pfizer mRNA vaccine in March 2021.
'It's ruined my life completely and utterly,' she told Daily Mail Australia.
'I am skin and bones. I don't recognise myself. It's not my body and I wake up with a new symptom every day. It's a grieving process.'
Ms Guevremont and her partner Richard Ellison, who moved to Australia from Canada seven years ago, said they were forced to sell their Manly unit because it was located on the fourth floor and she struggles with stairs.
They now live with their two boys in a ground-level home in the south-eastern Sydney suburb of Maroubra.
Ms Guevremont said she has spent more than $25,000 seeing specialists, including neurologists and rheumatologists, but has not found them helpful.
Mel Guevremont says she has been left in a wheelchair after three doses of the Covid vaccine
Her comments come after a landmark Covid vaccine injury class-action lawsuit was filed in April against the Australian government, the Therapeutic Goods Administration (TGA) and the Department of Health.
The nationwide suit, which reportedly has 500 members, seeks redress for those allegedly left injured or bereaved by the Covid vaccines.
Ms Guevremont said she was a fit and healthy woman who regularly took part in outdoor activities - but her active lifestyle has drastically changed.
'Right before these jabs I was snowboarding in New Zealand. The only problem I had was a tweaked knee from too much surfing and playing basketball,' she said.
'I was an adrenaline junkie. I did not stop. It's quite the clash for me to be barely able to hold a cup of coffee or hold my own neck.
'How do you go from snowboarding, ripping on a mountain and having a great time, to all of a sudden can't hold your neck?'
Ms Guevremont claims she is also suffering from electric shocks, unexplained weight loss and body weakness.
'I went to a beauty salon and after a while I couldn't feel my legs,' she said. 'When I tried to get up, my legs just completely collapsed. I sort of laughed and brushed it off. 'I thought maybe it was related to post-pregnancy hormones.'
Ms Guevremont says she struggles to do basic physical activities like walk to the park or even pick up her two boys, who are aged two and four.
'It breaks my heart. My young one wants to play soccer, and he knows I played soccer with him before, and all of a sudden I can't,' she said. 'I wonder if I am going to be there for my kids.'
The mother has made farewell videos for her boys just in case she is 'not around' when they grow older.
In July 2021, Ms Guevremont caught Covid-19, which she said took her four days to get over, after which 'she was fine'.
In November 2021, her condition spiralled and she fainted and collapsed. 'My partner rushed me to the hospital and I stayed there for a week,' she said.
She said a specialist suggested she might have 'post-vaccination syndrome and potentially post-viral syndrome' - although she only wrote the second diagnosis in her notes.
In referrals seen by Daily Mail Australia, hospitals and neurologists have diagnosed Ms Guevremont with 'suspected vaccine injury'.
Last year, Ms Guevremont reported herself as a vaccine injury to the TGA but said she was still waiting for a response. 'They fail to follow up and investigate,' she said.
A TGA spokesperson told Daily Mail Australia an 'acknowledgement email requesting further information was sent in response to an adverse event report submitted by Ms Guevremont'.
They added: 'The TGA strongly encourages vaccine recipients and healthcare professionals to report their experience of suspected adverse events, even if there is only a very small chance a vaccine was the cause.
'The TGA uses these reports to look for patterns in reporting that may indicate a new safety signal for a vaccine.'
The spokesperson said such a signal will lead 'to appropriate regulatory action which may include making changes to a vaccine's Product Information and communicating information to doctors.
'To date, the TGA has initiated over 43 regulatory actions to include new safety information in Product Information documents,' the TGA representative said.
But Ms Guevremont said she felt 'abandoned' and turned to Kerryn Phelps, the former head of the Australian Medical Association, for help.
Last December, Professor Phelps told a parliamentary inquiry into long Covid that both she and her wife had been vaccine-injured.
Ms Guevremont said Professor Phelps was very kind and supportive in referring her to a neurologist who 'specialised in vaccine injuries' but who turned out to be too busy to see her.
She also condemned the vaccine-injury compensation scheme run by Services Australia. 'The compensation scheme is a joke,' she said.
The compensation scheme for Pfizer vaccines includes about 10 eligible conditions, but these don't include neurological conditions such as Guillain-Barre Syndrome and Transverse Myelitis, even though they are listed for AstraZeneca shots.
'The TGA and regulators around the world continue to monitor and analyse Covid-19 vaccine safety data covering hundreds of millions of people, and the latest evidence from clinical trials and peer-reviewed medical literature,' the TGA spokesperson said.
'This information continues to overwhelmingly support the safe and effective use of Covid-19 vaccines.
'It remains the consensus view of international regulators and health departments that the benefits of Covid-19 vaccination continue to far outweigh the rare risks.'
Ms Guevremont is currently looking at experimental treatments and possibly moving the U.S. to receive them.
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29 June, 2023
Partial return
I am still climbing out from under the tyranny of my seasonal virus so am not yet up to resuming a full schedule of blogging. I have however noted the rather shocking article below so reproduce it here today -- JR
Laid Low by the COVID Vaccine, Now They've Got a Bad Case of Federal Unresponsiveness
In April 2021, Adele Fox received a single shot of the Johnson & Johnson COVID-19 vaccine. Within a few hours, the 60-year-old resident of Portsmouth, New Hampshire, started feeling shooting pains in her legs, arms, and neck. The pain didn’t abate over the next few days. Instead, it got worse and was accompanied by nausea and debilitating fatigue.
Within a few weeks, neurologists affiliated with Massachusetts General Hospital diagnosed her with several serious conditions they say were a result of her COVID-19 vaccine, including small-fiber neuropathy (which causes a painful tingling in the extremities) and Sjögren’s Syndrome (which leaves patients pained and fatigued, and in extreme cases, can damage internal organs).
This shot, which was supposed to get Fox back to normal, instead left her with diminished ability to work and enjoy life. Persistent physical therapy and experimental treatments she’s taken since have done little to alleviate her symptoms.
“I used to do so much, and now it’s a struggle,” she says. “Sometimes you just get down.”
With her medical bills mounting and her condition not improving, Fox sought compensation for her damaged health. Federal liability protections prevent the vaccine-injured from directly suing vaccine manufacturers like Johnson & Johnson. Instead, claimants have to go to the federal government for compensation.
But as Fox would soon learn, the government has two starkly different injury programs for vaccines. One operates like a civil court with a neutral judge, lawyers on both sides, and a guaranteed right of appeal. In recent decades, it has approved about 75% of claims and pays out hundreds of millions of dollars per year.
The other, which handles COVID-19 vaccines, has rejected almost every claim brought to it, awarding less than $10,000 since the pandemic. And in a nation nearly numb to the pandemic's toll and its scandals, the program is adding seething frustration atop lasting injury to Fox and people like her in a little reported aftermath to the government’s much criticized performance on vaccines – ranging from erratic booster advice to broad-brush vaccine mandates that cost people their jobs.
Fox filed her claim two years ago, submitting hundreds of pages of medical documents about her condition and diagnoses. She’s nevertheless one of the 10,887 people still waiting on a decision. “You’re not even hearing anything from the organization that’s supposed be helping you,” she says. “The phone keeps ringing, no one is emailing, nobody is doing anything.”
The federal agency overseeing the program, the Health Resources and Services Administration, said in a statement to RealClearInvestigations that the current number of claims “significantly exceeds the previous volume in the program” and that the program has “hired additional staff to address this growth in claims, and the President’s budget requests additional funding to support the additional staffing needed to process claims.”
Tale of Two Compensation Programs
The government’s two contrasting vaccine compensation programs are similarly named and thus easily confused. The first, Vaccine Injury Compensation Program (VICP) was created in the 1980s and covers most routine vaccines. The second, the Countermeasures Injury Compensation Program (CICP), is a result of war-on-terror legislation in 2005 and now covers COVID-19 vaccines. Their bureaucratic differences help explain why a nation that has spent trillions of dollars on COVID relief programs has provided almost no assistance to people harmed by the vaccines that the government encouraged, and sometimes required, them to take.
The earlier program was supposed to shore up pharmaceutical companies’ willingness to make childhood vaccines in the face of persistent vaccine injury lawsuits, while also giving the vaccine-injured a fair and expedited process for compensation.
The vaccine-injured would not sue pharmaceutical companies. Instead, they’d petition the government in Federal Claims Court, where special masters (judges) would decide cases. Compensation came from a government-administered trust fund paid for by excise taxes levied on vaccine manufacturers.
Between 2006 and 2021, this court adjudicated cases from 10,602 petitioners and issued compensation to 7,618 of them. The compensation trust fund sits at $4 billion and pays out about $200 million in compensation and attorneys’ fees each year.
This earlier program bears little resemblance to the Countermeasures Injury Compensation Program, where the COVID-vaccine cases of Fox and many others are languishing.
It was meant to incentivize pharmaceutical companies to be part of the federal response to one-off, one-in-a-million events like a bioweapon attack or an outbreak of a deadly pandemic. Although almost one billion doses of COVID-19 vaccines have been administered in the United States, and health authorities say boosters could become as common as the annual flu shot, it remains the only way people harmed by the shot can receive compensation.
It's far from guaranteed they’ll get it.
Before the pandemic, this program received a little over 500 claims and had paid out compensation to only 30 people – mostly for H1N1 (swine flu) vaccine injuries. In just the past two years, it has been asked to make decisions on over 10,000 injury claims related to COVID countermeasures.
As of June, it made decisions on just 919 of these COVID-related claims and rejected 894 of them. It has so far paid out only $8,593 in compensation to just four people who were injured by a COVID vaccine. The program has deemed another 20 people eligible for compensation, but has yet to pay them.
It’s not a judicial process either. Rather, it’s an administrative process overseen by Health Resources and Services Administration, which is housed within Department of Health and Human Services (HHS). People file a claim and government medical reviewers decide whether to pay out or not. That’s an awkward arrangement, given that HHS is deciding whether to pay for damages caused by products it approved and in some cases mandated.
Because it’s an administrative process, there’s no right to counsel and no neutral arbitrator. A denied claimant can file for reconsideration with HRSA, but otherwise has no right to appeal.
Unlike the earlier program, the CICP offers no compensation for pain and suffering and doesn’t pay attorneys’ fees. Most successful claimants have received compensation totaling a few hundred dollars or a few thousand dollars. The highest award for a COVID-19 vaccine injury sufferer was $3,957.66 to a person who got myocarditis (a heart condition) from a vaccine.
It also has shorter filing deadlines. People have to file a claim within one year of vaccination, a much shorter window than the earlier program’s standard of three years from the onset of symptoms. Of the 894 claims that CICP has rejected, 444 of them were for missing the filing deadline.
CICP also only awards compensation in cases where there’s “compelling, reliable, valid, medical, and scientific evidence” that someone’s injury is linked to a covered countermeasure. HRSA describes this as “a high evidentiary standard.” Renée Gentry, a practicing vaccine injury lawyer who directs the Vaccine Injury Litigation Clinic at George Washington University, says it’s a much higher bar than what the earlier vaccine injury compensation program requires, which contributes to a much lower rate of successful claims.
The Countermeasures Injury Compensation Program’s nature as a small emergency program has seen its capacity strained by a flood of COVID-related injury claims. Of the 11,806 COVID-related claims filed, 10,887 are still pending. Those four cases where COVID compensation was paid out didn’t come until after April 2023, over two years since the first vaccines were administered.
Pain and Suffering
The shortcomings of CICP are all too apparent for the people who are forced to wade through it. Even folks who seem to have done everything right are left waiting or disappointed by the program.
Fox filed her claim in May 2021, which was relatively early in the immunization campaign. She also had clear diagnoses from well-credentialed doctors linking her conditions to her COVID-19 vaccination. Fox says she provided the program with no shortage of documentation as well.
After filing all that paperwork, she hasn’t been idle either. After months of not hearing anything back from CICP, Fox started to reach out repeatedly to anyone she thought might be able to move the needle. She spoke repeatedly with representatives from Sen. Jeanne Shaheen’s and Rep. Chris Pappas’ offices. She also kept calling program administrators, trying to figure out what was taking so long.
“I’m sure they saw my number, and said ‘Ah, Fox, oh no, not her [again]’,” she jokes.
Her congressional representatives did reach out to CICP on her behalf. That was at least effective at getting program administrators to call Fox personally twice, once in July 2022 and again in June 2023. But each time, they could only offer her reassurance that her paperwork had been received. On both calls, Fox says she was told that the program was vastly overburdened by the flood of COVID-19 claims it had received. She, like thousands of others, would have to wait.
The few decisions on COVID-19 claims that have trickled out haven’t offered much relief to the people who’ve received them. That includes Cody Flint, one of the 894 people who’ve had their COVID-related claims rejected.
Flint was vaccinated in February 2021, when he received a single Pfizer dose. He says that he started to feel headaches and had affected vision within 30 minutes of the shot. He was still experiencing symptoms two days later when he headed to his job as a crop-dusting pilot.
While flying that day, he started to experience extreme tunnel vision, followed by a sensation he describes as “a bomb [going] off in my head.” He barely managed to get his plane back to his runway, where his coworkers found him slumped over his controls and shaking.
He was diagnosed with perilymphatic fistula (or tear of the inner ear) caused by elevated intracranial pressure – which could only be relieved through repeated draining of his spinal fluid. Given the timing of his symptoms and the fact that he’d passed a flight physical just a couple weeks prior, his doctors said his condition was almost certainly caused by the vaccine. His injury prevented him from returning to work as a pilot, and his mounting medical bills saw him draw down all of his savings.
In April 2021, Flint filed a claim. In May 2022 – just a few weeks after Sen. Cindy Hyde-Smith asked HHS Secretary Xavier Becerra about his case specifically in a committee hearing – Flint’s claim was rejected. The program’s medical reviewers told Flint that it was more likely his injuries were caused by barotrauma from flying a plane.
He petitioned for a reconsideration of his case. His doctors argued that there was no way he’d have experienced barotrauma from flying just a few hundred feet off the ground. Commercial airliners, they noted, are pressurized at 6,000 to 8,000 feet of elevation. Flint’s lawyers also submitted recent studies linking the symptoms he’d experienced to COVID-19 vaccinations.
Nevertheless, a separate medical reviewer at HRSA upheld the CICP’s initial denial in January 2023. That letter succinctly stated that HHS has “no appeals process beyond this reconsideration” and “there is no judicial review of a final action concerning CICP eligibility.”
Efforts at Reform
The federal government’s liability protections for COVID-19 vaccines aren’t scheduled to expire until the end of 2024. Once they do, those claiming a vaccine injury will be able to pursue claims against vaccine manufacturers in state courts.
While liability protections remain in effect, the federal program is injured claimants’ only potential source of compensation.
Whether or not the HRSA succeeds in boosting staffing in line with its statement to RCI, those seeking compensation have started to get organized. They’ve formed the group React19, which is dedicated to advocating for additional research into the side effects of COVID-19 vaccines. It’s grown into a network of tens of thousands of people who say they suffered adverse injuries from the shot. Flint, the pilot, is on its board of directors.
“It’s a very pro-vaccine community,” says Christopher Dreisbach, the group’s legal affairs director. “You say anything about vaccine injuries, you’re branded as anti-vaxxers. We are pro-science, we are not political. We’re just dealing with a very politicized issue.”
He says the politicization of vaccines has made their efforts at compensation reform a challenge.
When the CICP, and the 2005 Pandemic Response and Emergency Preparedness (PREP) Act that created it, were first being debated, Republican lawmakers were its main advocates, while its main critics were Democrats. The partisan politics of the program and liability protections for pharmaceutical companies has done a 180 since COVID.
In 2005, Rep. Sheila Jackson Lee argued during the House floor debate on the PREP Act that the law’s liability shield would leave injured healthcare workers with little protection or chance of compensation. Come 2023, she would return to the floor of the House to argue in favor of mandating those same healthcare workers receive a vaccine covered by the PREP Act’s liability shield.
The PREP Act’s harshest critics during COVID, meanwhile, have mostly been Republicans.
“I call the PREP Act medical malpractice martial law,” says Rep. Thomas Massie, who complains that its liability shield is both incredibly broad and improperly preempts state law. “I think it’s sort of anathema to the way our government is set up. I found it hard to believe that Congress would pass something, much less that a Republican president would invoke it.”
In March 2022, Sen. Mike Lee introduced a bill that would have amended CICP to give claimants the same framework for pursuing compensation as the VICP. They could file in Federal Claims Court and receive an expedited, judicial adjudication of their injury claim.
Gentry argues that it would be far simpler to just move the COVID-19 vaccines into the VICP program, which already has a successful track record of adjudicating injury claims. In order for that to happen under the law that created the VICP, the CDC needs to recommend the vaccines for routine administration to children (which has already happened) and vaccine manufacturers would have to start paying excise taxes. That latter condition will require action from Congress.
VICP needs a number of updates as well, says Gentry, including expanding the number of special masters to handle the backlog of cases and increasing the available levels of compensation (which haven’t been updated since the 1980s).
Increasing the number of special masters is particularly important if the VICP program is going to be expected to process tens of thousands of COVID claims, she says. But she argues it’s the best way of getting the vaccine injured out of CICP and into a program that will work for them. “If you’re taking away someone’s constitutional right to sue, you really have to give them a reasonable and meaningful alternative and that’s what this program is, for all of its faults,” says Gentry.
While efforts at reform in Washington lumber on, React19 has started a privately funded compensation program that’s thus far paid out $552,000.
“Is that making a meaningful difference to all the vaccine injured everywhere? No, that’s not enough,” says Dreisbach, but he notes that it’s far more than what CICP has paid out. “That should be pretty embarrassing to the federal government.”
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27 June, 2023
'Stunning' Emails Show What Biden Administration Officials Knew About COVID Vaccines Very Early On
Newly released emails obtained through a Freedom of Information Act request show that public health officials knew about “breakthrough cases" of COVID-19 in vaccinated individuals early on, but continued pushing vaccine mandates anyway.
Centers for Disease Control and Prevention Director Rochelle Walensky discussed in a January 2021 email how she had spoken to then-NIH Director Francis Collins about the issue.
“Dear all, I had a call with Francis Collins this morning and one of the issues we discussed was that of vaccine breakthroughs. This is clearly and [sic] important area of study and was specifically called out this week here,” she said, adding a link to a paper titled, “SARS-CoV-2 Vaccines and the Growing Threat of Viral Variants.” She goes to say she discussed this with someone “a few weeks ago” and that Dr. Anthony Fauci was also aware.
In media hits months later, however, Walensky was saying that vaccinated individuals “don’t get sick” and “do not carry the virus.”
"Our data from the CDC today suggests that vaccinated people do not carry the virus, don't get sick, and that it's not just in the clinical trials, but it's also in real-world data,” she said on MSNBC in March of 2021.
She then defended those comments in a congressional hearing, arguing it was true when she said it, though it “did change over time.”
In May of 2021, Fauci made similar claims, telling Americans that vaccinated individuals "become a dead end to the virus."
"Even though there are breakthrough infections with vaccinated people, almost always the people are asymptomatic and the level of virus is so low it makes it extremely unlikely — not impossible but very, very low likelihood — that they’re going to transmit it,” Fauci told CBS's "Face the Nation."
“When you get vaccinated, you not only protect your own health and that of the family but also you contribute to the community health by preventing the spread of the virus throughout the community,” he added. “In other words, you become a dead end to the virus. And when there are a lot of dead ends around, the virus is not going to go anywhere. And that’s when you get a point that you have a markedly diminished rate of infection in the community.”
Sharing the email, Stanford School of Medicine professor Jay Bhattacharya called the revelation "stunning."
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Australia Removes Moderna Vaccine for Children Under 5
Health authorities in Australia have quietly removed Moderna’s paediatric COVID-19 vaccine for children five years and under, with both options offered by the company now no longer available in the country.
This comes after the Australian Technical Advisory Group on Immunisation (ATAGI) announced it would no longer recommend COVID-19 vaccines for individuals who are under five unless they have one of seven specific high-risk medical conditions that could place them in heightened-risk categories for severe COVID-19.
The seven conditions include severe primary or secondary immunodeficiency, including those undergoing treatment for cancer or those on immunosuppressive treatments; bone marrow or stem cell transplant or chimeric antigen T-cell (CAR-T) therapy; complex congenital cardiac disease, structural airway anomalies or chronic lung disease, type 1 diabetes mellitus, chronic neurological or neuromuscular conditions or a disability with significant or complex health needs.
“ATAGI does not currently recommend vaccination for children aged 6 months to <5 years who are not in the above risk categories for severe COVID-19. These children have a very low likelihood of severe illness from COVID-19,” the advisory body said.
The Epoch Times has reached out to Moderna for comment on the decision.
Moderna Vaccine Only Gave Modest Protection: ATAGI
In justifying its change of advice, the health authority said that there was a very low risk of severe COVID-19 in healthy children aged six months to less than five years.
“This age group is one of the least likely age groups to require hospitalisation due to COVID-19. Among the small number who are hospitalised or who die due to COVID-19, underlying medical conditions or immunocompromise are frequently present,” ATAGI said.
They also noted that the age cohort had a relatively low rate of paediatric inflammatory multisystem syndrome (PIMS-TS) following COVID-19 compared to other older children, and this further declined with the Omicron variant compared to ancestral SARS CoV-2 strains.
Further, the health advisory group noted that a clinical trial of 5,500 children aged six months up to five years demonstrated that the Moderna COVID-19 vaccine provided only modest protection against infection, while safety data reported patterns of vaccine-related adverse events.
“Up to one in four children in this age group had a fever following vaccination with Moderna vaccine, with higher rates seen in those with a history of previous COVID-19,” they said.
“As fever in this age group can sometimes result in medical review and/or investigations and occasionally trigger a febrile convulsion, the side effect profile for this vaccination needs to be considered in the risk-benefit discussion.”
Additionally, the health authorities also changed their advice on COVID-19 booster shots for those 18 and under, with the body now recommending that children and adolescents aged under 18 years who do not have any risk factors for severe COVID-19, should not receive a booster shot.
Omission of Children’s COVID-19 Vaccine Deaths In Australia Raises Concerns
The changing advice follows concerns in March that Australia’s drug regulator was too slow to update the country’s Database of Adverse Event Notifications (DAEN) despite several deaths being attributed to the vaccine, including two children, aged 7 and 9.
The information came to light following a Freedom of Information request by an Australian doctor that found the delayed response from the Therapeutic Goods Administration (TGA).
Senator Gerard Rennick said he would push for independent oversight of the TGA.
“A third independent medical party should examine the evidence as the TGA has a conflict of interest because they approved the vaccines and would therefore be held responsible for the deaths of these children due to poor regulatory oversight,” Rennick told The Epoch Times.
The senator also said he was concerned that the TGA was soft-pedalling the risks with the COVID-19 vaccines, especially around myocarditis and cardiac arrests.
“They are definitely downplaying the risks. They do not have enough information to rule it out given the known link between the vaccines and myocarditis and myocarditis and cardiac arrests,” Rennick said.
The TGA states that they “rigorously assess any COVID-19 vaccine for safety, quality and effectiveness before it can be supplied in Australia.”
As of June 19, the DAEN states that since the beginning of the vaccination rollout in Australia, there have been 138,645 adverse events reported to the federal government. Of those, 135,126 are believed to be directly related to the vaccines, while 991 are reportedly vaccine-related deaths.
Further, in the age cohort of six months to 17, there have been 5,817 adverse events recorded, with 5,689 attributed solely to COVID-19 vaccines. Nine children and adolescents have also reportedly died as a result of an adverse vaccine reaction.
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Large 1.3M Observational Study on Vaccine & Previous Infection-Based Effectiveness Against Omicron
How effective are the COVID-19 vaccines in children? This is a study question pursued by a biomedical research team led by physicians and scientists at University of North Carolina Gillings School of Public Health in an observational cohort study based on electronic health record-based vaccination records involving outcomes associated with Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273) mRNA-based COVID-19 vaccines.
Data for this observational type of study originate from the North Carolina COVID-19 Surveillance System and the COVID-19 Vaccine Management System for 1,368,721 North Carolina residents aged 11 years or younger from Oct 29, 2021 (Oct 29, 2021 for children aged 5–11 years and June 17, 2022 for children aged 0–4 years), to Jan 6, 2023. Cox regression statistics were utilized to arrive at time-varying effects of both primary and booster vaccination and previous infection on the risks of Omicron infection, hospital admission and death.
Oddly, the study team didn’t collect side effect data. The authors find the mRNA vaccines effective, but their protective effects wane. The study team touts what is highly robust protection associated with previous infection (natural immunity) which against some parameters wanes slower than vaccination.
This study characterized the long-term effects of vaccination and previous infection to Omicron infection and severe outcomes in children aged 5-11 years. They compared the effectiveness of monovalent and bivalent boosters in the cohort. Also, the investigated estimated the time-varying effects of vaccination and previous infection on omicron infection, and severe outcomes in children aged 0-4 years. The study records covered all lineages of the Omicron variant.
Findings
What about primary vaccination vs monovalent booster dose? The study team points out in The Lancet that the effectiveness of a monovalent booster dose after month one equaled 24.4% (14.4-33.2) and that of a bivalent booster dose equaled 76.7% (45.7-90.0%).
What about previous infection? That is, children that were infected with SARS-CoV-2 (Omicron variant), and the protective effect against Omicron reinfection. The data reveals preexisting infection is quite effective at 79.9% (78.8-80.9%) after month three, and 53.9% (52.3%-55.5%) by month 6.
When looking at the youngest cohort—age 0-4 years—the University of North Carolina team found that effectiveness of primary vaccination against infection, when compared to unvaccinated status, equaled 63.8% (57.0-69.5%) by month 2 after the jab, and 58.1% (48.3-66.1%) at month 5 after the first dose.
Previous infection for this cohort, which was frequent and represented low risk overall, exceeded vaccination at 77.3% (75.9-78.6) at month 3 and 64.7% (63.3-66.1) at month 6.
Across both age groups, both vaccination and previous infection were reported as better effectiveness against severe illness as measured by hospital admission or death, as a composite endpoint than against infection.
Summary
Vaccination was effective in helping to prevent Omicron infection as well as more severe infection, but like all other studies reveal with the mRNA vaccines, that protection wanes over time. The bivalent boosters were more effective as compared to the monovalent boosters. Importantly, the authors denote, “Immunity acquired via Omicron infection was very high and waned gradually over time.”
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26 June, 2023
Was the COVID Vaccine Safe for Pregnant Women?
MARTY MAKARY
In December 2020, just before the vaccines for COVID-19 were first released to the public, Dr. Mandy Cohen, the Secretary of the Department of Health and Human Resources in North Carolina, urged everyone to get vaccinated as soon as they were able. “Corners were not cut,” Cohen said with confidence.
Then as now, pregnant women asked if COVID vaccines were safe for them. Public health officials said “yes” when the correct answer should have been “we don’t know yet,” given that pregnant and breastfeeding women were excluded from the original COVID vaccine trials. With Cohen set to replace Dr. Rochelle Walensky as director of the Center for Disease Control at the end of June, it is a good time to consider how Walensky performed on COVID—and in particular, on Women’s health issues—and ask whether Cohen will be any different.
In February 2021, to settle the controversy over whether the COVID vaccines should be used during pregnancy, Pfizer launched a randomized controlled trial of 4,000 pregnant women. But five months into the study, after enrolling 349 women, the study mysteriously stopped recruiting. Pfizer never offered a reason. Most concerning, the pregnancy outcomes of those who participated in the trial, and their babies, are still not public today, nearly two years later.
But the CDC did not wait for good data to make a decisive recommendation. In April 2021, just four months after the COVID vaccine was first granted an emergency use authorization and two months into the then ongoing Pfizer pregnancy trial, Walensky decided not to wait for the trial results, and instead recommended that all “pregnant people” get the vaccine. Three months later, the American College of Obstetricians and Gynecologists (ACOG) followed the CDC and “enthusiastically” recommended it as well.
Concerned by the zealousness and absolutism of this recommendation in the absence of evidence, a group of scientists and I petitioned the FDA to add a disclaimer to the vaccine label stating that no randomized trial data is available on the vaccine in pregnant women.
A few months ago, the FDA’s Dr. Peter Marks wrote back to us, denying our request. “The Petition fails to explain how including the fact of no results being reported would be relevant information that would contribute to the safe and effective use of the vaccine,” he claimed.
In other words, women don’t need to know. Just get vaccinated.
Not having any good data didn’t seem to bother the CDC.
Can a vaccine have a different safety profile in pregnant women than in the general population? There’s actually a precedent. The CDC advises that pregnant women not receive the HPV, MMR, or chickenpox vaccines, and instead recommends taking them before or after pregnancy, when indicated.
Remarkably, as the now outgoing CDC director—along with the ACOG—was pushing COVID vaccine absolutism for all pregnant women (regardless of preexisting natural immunity), a June 2021 New England Journal of Medicine editorial on COVID vaccines warned readers of “the dearth of safety information about pregnancy.” The article added the importance of waiting for Pfizer’s pregnancy trial to shed light on the matter, but alas, the early results are still locked up.
Pharma companies actually have a track record of halting trials that aren’t going their way and hiding results they don’t like. It allows them to control the narrative and manipulate markets. In many cases where data is hidden, Pharma companies play doctors like a fiddle.
A 2021 study by Yale, Stanford, and the University of Pennsylvania published in The BMJ found that out of 58 new drugs that the FDA approved in a two-year period, 33% did not make their trial results public, according to the researchers’ review of the data six months after the drugs’ approval. In 2004, Merck famously withheld clinical trial findings that Vioxx, their newly approved drug that was being used by 80 million Americans, increased heart attack risks. Vioxx was eventually pulled off the market.
In the case of the COVID vaccine trial in pregnant women, the trial may have been terminated not because the results were unfavorable, but because no data was needed. The medical and public health establishments had already made up their minds, declaring it safe and effective regardless of what the data was going to show. Why evaluate a product if the CDC and ACOG are already sold on the product?
Using the same groupthink science, the CDC and ACOG are now blindly recommending boosters and the new bivalent vaccine for healthy pregnant women, and once again ignoring the role of natural immunity. The ACOG website does not cite any clinical trials to back their recommendation, of course. Not only does the new bivalent vaccine lack any randomized trial data in pregnant women, it lacks any randomized trial data in humans (it was authorized based on data from eight mice).
Recently, public health officials went a step further and proposed the idea that people will need an annual COVID shot. That would mean that the average 5-year-old girl would need 77 mRNA COVID vaccine shots in her lifetime. Given the known risks of myocarditis and blood clots with each shot, such a sweeping recommendation should be based on trial data, not dogma. A recent study authored by Dr. Joseph Fraiman in the journal Vaccine identified the rate of “serious adverse events” after the COVID vaccine to be 1 in 662 doses.
To their credit, ACOG’s website does acknowledge COVID vaccination could delay menstruation. A large COVID vaccine study published last July found that “periods were late by less than 1 day on average.” When asked about this, Dr. Anthony Fauci told Fox News’ Bret Baier, “The menstrual thing is something that seems to be quite transient and temporary. We need to study it more.” But saying for two years that we don’t have enough studies is ironic when Fauci himself commanded an annual research budget of $6 billion. A Swedish study published last month in The BMJ found that an adjusted 26% increased risk of menstrual disturbance after the COVID vaccine in women age 12-49.
Since early 2021 women were reporting changes to their periods and unexpected vaginal bleeding, calling for proper study. Last October, the European Union’s regulator advised that “heavy menstrual bleeding” be added as a side effect on Pfizer and Moderna vaccine labels. Here in the U.S. there’s been no such update to product labeling.
This lack of humility was also evident when healthy young women were told with incredible absolutism that the COVID vaccine cannot affect fertility. The right answer should have been: We don’t think it will affect fertility but we don’t have any good data on the question. A Journal of the American Medical Association (JAMA) study published last fall concluded that, “Findings of this study suggest that receipt of the first inactivated COVID-19 vaccine dose 60 days or less before fertilization treatment is associated with a reduced rate of pregnancy.”
The medical establishment has also blindly pushed for universal COVID vaccination and boosters in lactating mothers. This recommendation came before a study in JAMA Pediatrics discovered vaccine mRNA particles in breast milk. The finding was so unexpected that it became the journal’s No. 1 most discussed study of 2022, according to the JAMA website. Coming in second was a study reporting myocarditis after COVID vaccination, and third was a study I authored with my teams at Johns Hopkins on durability of natural immunity. It’s telling that the most discussed JAMA studies of 2022 were all on topics that public health officials have consistently downplayed.
In the absence of good data, organized medicine chose the path of stern paternalism. But in my experience as a physician, it’s far better to properly inform a patient rather than steamroll their questions. It may be that Pfizer’s pregnancy trial would have been favorable to the vaccine, showing that the benefits outweigh harms, but Pfizer has not released the data. Perhaps the data was not favorable, or perhaps Pfizer realized they had convinced the medical establishment without data, so why run the risk of sharing what a placebo-controlled trial shows?
In the absence of good data, organized medicine chose the path of stern paternalism.
Perhaps the most famous example of hidden trial data is the 1989 Minnesota study that found there were more deaths in the group that ate a low-fat diet than in the control group that did not. The study was completed in 1973, 16 years before it was released to the public. When asked about the delay, the lead investigator, Dr. Ivan Frantz, famously said “we were just so disappointed in the way they turned out.”
The FDA recently authorized a second round of COVID bivalent vaccines for people over the age of 65, with no supporting clinical data. The authorization came a month after the FDA leaked to the press their intention to do so. This is the Biden administration’s new way of running the FDA. Leak something to the media, gauge public backlash, and fast track authorization of the drug without the supporting data typically required.
Is the COVID vaccine safe in pregnancy? Probably. But cutting corners on research and pushing vaccines without data is dangerous. It’s probably why 58% of women under age 50 say they do not trust public health officials when they say that the COVID vaccine is safe and effective in pregnancy, according to a University of Pennsylvania study published last month. Overall trust in the CDC is down from 69% pre-pandemic to 44% today. Dishonesty has consequences.
Even if the vaccine’s benefit outweighs the risks in healthy pregnant women, a review of 65 studies published in The Lancet in February concluded that natural immunity is at least as effective as vaccinated immunity, and probably more effective. So why is the medical establishment blowing through so much political capital on a blanket campaign to immunize those already immune?
For those who think the boondoggle of COVID policy has ended, consider the fact that just two months ago, public health officials beclowned themselves by insisting Novak Djokovic could not enter the U.S. to play tennis outdoors because he’s not vaccinated. This position, known as Biden’s “Djokovic doctrine,” embodies persistent errors in public health groupthink today, from ignoring natural immunity to downplaying vaccine induced myocarditis in young males to overlooking data on how extremely low risk the virus is for healthy young people to segregating people by vaccine status.
And just this week, the Biden White House required college athletes who won national championships visiting the White House to mask and stay six-feet apart if they are not vaccinated. Even if they have natural immunity. What does Mandy Cohen have to say about this standing policy still in place today?
To rebuild trust, the medical establishment—including physician associations and academic leaders—should be honest about what is known and unknown, rather than lock arms and broadcast its dogmas as science. For every subgroup in the population, medical science has long held high the principle of requiring data before making strong recommendations. Women should not be treated any differently.
https://www.tabletmag.com/sections/news/articles/was-covid-vaccine-safe-pregnant-women
*******************************************************All-Cause Mortality Up after Mass COVID-19 Vaccination
Data from Japan and Germany display disturbing trend
Governments around the globe put a huge amount of faith in COVID-19 vaccines as their only intervention to reduce mortality. Yet, no prospective randomized, double-blind placebo-controlled trial has demonstrated a reduction in death with COVID-19 vaccines. On the contrary, every single data system around the globe has reported increased mortality coinciding with the roll-out of the vaccines.
Scherb and Hayashi used Japan and Germany for study of temporal trends in mortality. Both countries have excellent reporting systems. For Japan (125.7 M) and Germany (83.2 M), the WHO indicates as of 18, June 2023, and 14 May 2023, a total of 392,346,325 and 193,232,623 vaccine doses, respectively have been administered. This equates to 2-3 doses per person.
The authors found a disturbing jump in mortality coinciding with the start of mass vaccination. At the end of a pandemic, since the frail and elderly have suffered disproportionate casualties, there is usually a culling effect and mortality should go down. If the vaccines were effective, then certainly they should have dropped the death rate even more. The figures from Japan and Germany tell a different story.
https://www.trialsitenews.com/a/all-cause-mortality-up-after-mass-covid-19-vaccination-c5aaa4f2
********************************************************22 June, 2023
SARS-CoV-2 Mass Vaccination Likely Accelerates Viral Mutation—Time to Upgrade COVID-19 Vaccines?
The lead scientist at Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Saint-Petersburg, Russia, and an expert infectious disease modeler at University Medical Center, Utrecht, Julius Center, Epidemiology & Health Economics in the Netherlands combined their intellectual prowess to investigate SARS-CoV-2 immune selection pressures, ultimately producing an important, published analysis titled “Evolutionary implications of SARS-COV-2 vaccination for the future design of vaccination strategies.” Mass vaccination was the “pillar of the public health response to the COVID-19 pandemic.”
But critics such as Geert Vanden Bossche, a TrialSite contributor, warned that mass vaccination might trigger mass evolutionary pressures, thus accelerating pathogen mutations. The Belgian virologist was summarily dismissed by mainstream science and its media channels as an overreacting crank. However, here, an intellectually gifted duo based in Russia and Holland raise the specter that based on their modeling “mass vaccination might accelerate SARS-CoV-2 evolution in antibody-binding regions compared to natural infection at the population level.”
In what should be a must read for decision makers in vaccination, the authors both review the most important factors shaping vaccination strategies during the COVID-19 crisis, while also probing the implications of SARS-CoV-2 vaccination on virus evolution in light of accumulated knowledge and in the context of viral evolutionary theory.
Their analysis raises the specter of a reality involving the evolution of rapidly mutating antibody-binding regions. Finally, the pair acknowledge the need for their own assumptions to be validated, while also pointing to the need for the research necessary to design potential future advancements in both vaccination and broader vaccination strategy.
The basis for mass vaccination
The formidable pair introduce the reader to vaccination strategies in the context of COVID-19, educating that primary tools employed during the pandemic were predictions based on robust epidemiological models tailored to the available data. Called “dynamic transmission models” or “infectious disease models”, they were used to simulate the transmission of a virus across a specific population, introducing and evaluating potential software simulated control measures.
It was, after all, transmission models for the virus, including mutation and how vaccination would respond, that were used to develop vaccination schemes during COVID-19: many national strategies were based on these models.
Key assumptions
Embracing material evidence of robust genetic variation in antibody-binding regions of SARS-CoV-2, the authors both capitalize on the similarity involving both the envelope proteins of SARS-CoV-2 as well as influenza, the pair make a key assumption: “That immune selection pressure acting on these regions” of both COVID-19 and the flu are comparable.
The authors, hardening their data including assumptions, analyze and discuss implications for SARS-CoV-2 evolution based on a mathematical model developed initially for influenza. The duo, if their analyses are accurate, most certainly impacts the future design of SARS-CoV-2 vaccination strategies.
While mass vaccination helped reduce morbidity and mortality, in many cases, that was a temporal public health gain, due to the combination of both an evolving pathogen and what TrialSite has argued are limitations with the initial vaccination products (e.g., durability, breadth challenges, lack of sterilizing powers, etc.).
Chinks in the mass vaccination armor?
Both Rouzine and Ganna raise the specter of limitation to the current mass vaccination approach. They raise the critical concern that “vaccination can also have implications for SARS-CoV-2 evolution in antibody-binding regions, located in the spike protein that is targeted by the available vaccines. SARS-CoV-2 perpetually evolves due to its escape from the immune response in individuals induced by both natural infection and vaccination.”
In fact, the authors remind the reader that irrespective of vaccination, when it comes to a pathogen like SARS-Cov-2 accumulating mutations in T-cell epitopes and antibody-binding regions powers selection pressure to escape natural immunity.
The authors demonstrate via modeling that mass vaccination can in fact, increase this inherent pressure, thus accelerating SARS-CoV-2 evolution in spike epitopes when compared to natural infection. The authors model this, thus conveying the distinct possibility that the arguments of Vanden Bossche have some merit.
Future research
The authors’ time and effort into this investigation evidence ongoing concern. “If SARS-CoV-2 continues to cause the substantial burden of severe disease in vulnerable individuals, we should either design a type of vaccine that does not carry any potential danger of accelerating virus evolution in epitopes but is still effective against severe disease or find other methods of reducing virus circulation.”
Rouzine and Ganna introduce several research pathways to consider for ongoing investigation into better options. Will apex research institutes, national public health agencies and major centers of biomedical research be receptive?
Summary
While the authors contribute their customary kudos to the current response to COVID-19 mass vaccination scheme, completely bypassing the topic of serious safety signals, they acknowledge that the pathogen that caused the COVID-19 pandemic continues to evolve, escaping in many cases from both natural and vaccine-induced immunity.
Demonstrating the distinct possibility that mass vaccination schemes in the context of the SARS-CoV-2 pathogen may serve to accelerate its evolution in rapidly mutating antibody-binding regions when comparing to natural infection, Rouzine and Ganna point out that their conclusion rests upon fundamental assumptions, including A) that the immune selection pressure exerted on antibody-binding regions of SARS-CoV-2 are in fact similar to those of influenza and B) on existing multi-locus models of influenza evolution.
Capitalizing on similarities between the envelope proteins of both SARS-CoV-2 and influenza in antibody epitopes, they further acknowledge that their model’s assumptions must be tested and potentially hardened. But in these author’s favor—they’ve proven to be correct with influenza—they have a serious track record.
Emphasizing what are limitations with the current COVID-19 mass vaccination approach, the authors carefully warn public health leaders that the role of mass vaccination on SARS-CoV-2 evolution “should be acknowledged for future vaccination strategies that target most at-risk populations, especially if vaccination campaigns will cover a substantial part of the population.”
Key considerations in the next round of COVID-19 vaccine development: “Mutations in immunologically relevant genomic regions, viral recombination, virulence and fitness evolution.”
The authors conclude by validating the current approach as likely the best considering all the factors involved (emergency pandemic, etc.).
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Covid heartburn on Twitter
It’s incredible how soft some people are on social media. And I’m not even talking about overly political people right now. A mass exodus of scientists and medical professionals appears to be leaving Twitter because they can’t handle the trolls. Do they know of these fantastic features called the “mute” and “block” buttons that drown out the clowns? Some are annoying, but if they’re asking questions and looking for a debate, you can choose to or not to engage with them. Those with too much time on their hands focusing only on ad hominem attacks should be blocked. It’s not complicated.
Conservative women, especially, have been subjected to heinous harassment by progressives, who are, at their core—just miserable people. Incapable of accepting differing views and the people who hold them for some reason. They have an addiction to harassing people to cower to their political opinions. While not religious, left-wingers do carry the same evangelist zeal, stunningly intolerant that some people think differently than they do. We’re supposedly on the "wrong side of history"—how often have you heard that phrase— and they can’t sleep at night knowing everyone doesn’t think alike under the authoritarian ethos of progressivism.
And yet, scientists decide to leave the battlefield because some no-name trolls decide to call out these people about vaccines. Galileo was tortured and didn’t bend. Eppur si muove has lost its meaning. The fireworks began when Dr. Peter Hotez appeared on Joe Rogan’s podcast (via Axios):
A feud broke out on Twitter over the weekend between popular podcaster Joe Rogan and prominent vaccine researcher Peter Hotez, with the podcaster challenging the scientist to a debate about vaccines in an online skirmish that drew fire from a few billionaires.
Why it matters: The incident — which ultimately resulted in individuals approaching the scientist outside his home — highlighted the potential risks for researchers and medical professionals using the platform, which saw a rise in hate speech after its acquisition by billionaire Elon Musk.
[…]
The Twitter battle over the weekend started after Rogan hosted Democratic presidential candidate Robert F. Kennedy Jr. on his show for three hours, spending much of the time talking about anti-vaccine views.
In response, Hotez, part of a Nobel Prize-nominated team that created an affordable, patent-free COVID vaccine for use in poorer countries, retweeted a Vice article with the headline "Spotify Has Stopped Even Sort of Trying to Stem Joe Rogan's Vaccine Misinformation."
The show spread "nonsense," Hotez tweeted.
That prompted a challenge from Rogan to Hotez: "Peter, if you claim what RFKjr is saying is 'misinformation' I am offering you $100,000.00 to the charity of your choice if you're willing to debate him on my show with no time limit."
What happened next: Rogan's challenge sparked an internet pile-on against Hotez, accusing him of being a "pharma shill," as well as a back-and-forth between some of Twitter's most influential, including Musk and billionaire investor Mark Cuban.
[…]
What they're saying: Twitter is "no longer a tool that's accelerating science. On the contrary," said Michael Mina, chief science officer at eMed and a pediatric immunologist who regularly used Twitter during the pandemic to talk about COVID. He still uses Twitter, but sparingly, and expects he'll leave completely within the next six months, he said.
"It allowed me to effectively and efficiently sift through the noise of this massive explosion of new publishers and journals and papers that were published," Mina told Axios.
[…]
In comments to Axios as well as online, scientists and medical researchers have said they're increasingly finding it difficult to find relevant information on Twitter. A recent study found Twitter's new algorithms are amplifying anger more since Musk took over the platform.
Hotez told Axios he's seen a clear shift in anti-vaccine views as part of a well-organized, well-financed anti-science movement, and that's playing out on the platform.
Of course, Axios finds a way to thread a swipe at Elon Musk’s takeover of Twitter. There are ways to moderate your communities, as mentioned above. The publications added that scientists are posting elsewhere, like Substack. Still, the fires of outrage over vaccines could be addressed if the medical community owned up to the misinformation about the COVID vaccine and the pandemic. We were told to get the shot, take off the mask. The efficacy rates were touted as the main selling points. And then the vaccinated got COVID during the Omicron wave.
There have been shiploads of people dying from cardiovascular episodes, many under 44. And now, we’ve learned that those who have contracted and survived infection had an antibody response that was just as good as those vaccinated with two doses of the mRNA vaccine. The reality of the vaccine is that it might prevent death, but there’s no protection against infection. It’s very much like the flu shot, which has an efficacy of less than 60 percent, but it does increase the odds of you not dying from the virus that kills tens of thousands of Americans every winter.
But that fact dilutes the panic and fear the COVID regime sold to us for months over a virus with a 99-plus percent survival rate. People got vaccinated and still contracted COVID, with some dying from infection, especially older Americans. And now, with boosters, we’re learning that it weakens the immune system. Until these philosopher kings admit they blew it on COVID, expect more angry folks to confront them.
The online shenanigans still pale compared to what Galileo and other scientists of his era endured when presenting their scientific findings. Imagine being tortured for suggesting the Earth revolves around the sun. He stood firm while today’s Dr. Hotez mulls leaving because it’s too heated on Twitter. Yikes.
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21 June, 2023
Analysing a vaccine critic's claims
Should there be a Royal Commission conducted as part of the Australian government’s COVID-19 emergency response? That’s the opening question media personality professor David Flint David asks Malcolm Roberts, an Australian politician on the “Save the Nation” show.
Roberts, a member of right-leaning populist One Nation and a Queensland senator since 2019, replied “Absolutely.” In an interview on the “malfeasance” associated with the Australian government’s response to COVID-19, Malcolm Roberts speaks some truth, but at some points in the conversation conveys points that aren’t necessarily true or conclusively proven as fact.
COVID-19 shines a spotlight on the politicization of medicine across the board, from right to left, from so-called “old” industry to so-called new green industry advocates—they all are using the unfolding science to make their convenient point. But some of what Roberts has to say cannot be ignored. Of the more controversial stances, it’s proven that the 30,000 excess deaths in Australia in 2022 were caused by the mass COVID-19 vaccination countermeasure response to the SARS-COV-2 pandemic.
Roberts told Professor David Flint that in March 2021, as the mass COVID-19 vaccination campaign got underway, he asked both the Chief Medical Officer (CMO) of Australia and the head of the Therapeutic Goods Administration (TGA), the nation’s drug regulator, if the vaccines were 100% safe.
The Australian senator shared, “The immediate answer was, no they are not.” TrialSite reminds all that no vaccines are 100% safe. There are no perfect solutions to public health. There are instead tradeoffs where hopefully smart, objective biomedical scientists, physicians, regulators and other relevant experts in their respective fields determine the risk-benefit analysis—do the benefits of such vaccines markedly outweigh risks at a population/societal level? But that’s the reality of how vaccination works. Thus, Robert’s first question to the heads of Australia’s vaccine response was just not based on a notion of reality.
But Roberts' second question to the CMO and head of TGA was more on point, a question grounded in real-world reality. He asked, “Will they stop someone from getting the virus?" He told the interviewer that these top medical and regulatory heads in Australia declared, “No they will not.”
So, this was an honest answer. By March 2021, TrialSite was already learning of breakthrough infections due to the Delta variant, meaning that these COVID-19 vaccines were not of the sterilizing type. They could not stop all infectious transmission meaning that they could not be counted on to control the pandemic.
Nearly all developed nations produced public health data showing how the jabs did help reduce the incidence of morbidity and mortality associated with COVID-19 and although critics don’t believe those numbers, they don’t take time either to prove why they are incorrect.
However, the durability of the mRNA products became a serious question early on—by the spring of 2021. A significant issue was mRNA vaccine durability, so ultimately, three boosters were necessary in a period of just over a dozen months after the first primary series. While the RNA virus was mutating, this was a well-known topic. But it remained politically incorrect to even critique the vaccines for fear of creating vaccine hesitancy---something was terribly wrong.
Back to the interview, Roberts told the Save the Nation host he then asked the top medical and regulatory brass of Australia, “What dosage will you be administering the vaccines, the injections?" The Senator told Professor Flint that these powerful overseers of COVID-19 vaccine response declared, “We don’t know.”
The Australian senator summarized, “So they don’t know the dose, they know that it's not effective, they know that it won’t stop transmission, and they know that it's not 100% safe.” He paused and continued, “There is no benefit from these things, none whatsoever.”
Roberts then said, “In fact, efficacy goes into the negative after some time with people who have had these injections because it destroys the immune system.”
Mandates down under?
What about injection mandates in Australia? The Senator told the Save the Nation host that the head of the county at the time, Scott Morrison, would go on television and repeatedly lie to the Australian public that there were no such mandates.
According to Roberts, “Scott Morrison bought the injections, he gave them to the states, he then indemnified the states for their use, he then gave them access to the National Health Data, which enabled the injection to be mandated, because otherwise, the states couldn’t have enforced the mandate.”
Roberts continued, “Then we had the state premiers at the same time telling us that the reason they wanted mandates was to comply with the national cabinet.” He continued, “Well, the head of the national cabinet, which is a bogus entity as you know, was Scott Morrison.”
His point—“Scott Morrison drove the whole thing in this country.”
As part of the national Australian emergency Roberts emphasized that Morrison "redistributed taxpayer money to states for COVID-19 lockdowns (Australia was notorious in the Western world for these) and other inhuman restrictions, ineffective, damaging restrictions that weren’t effective in managing COVID.”
A correction, as TrialSite reported during the pandemic, Australia to some extent embraced the Chinese zero-tolerance COVID policy which meant strict enforcement of rules and regulations to prevent the spread of the virus. It implies that any violation of these rules would not be tolerated, and appropriate action will be taken to enforce compliance.
The specifics of zero tolerance policy for COVID-19 vary depending on the nation, context of jurisdiction, and the like. But some common elements were embraced by the Australian national and state government. This in fact, did stop the spread of COVID-19 (Australia wasn’t hit early on nearly as hard as places like America), but the policy in reality only delays the eventual spread of the pathogen, at great cost to human psychology, cultural vitality and economy we might add.
What’s Senator Roberts’ takeaway on the Australian gov response to COVID-19?
The pandemic response was “completely mismanaged, deceitful, it killed thousands of people…” Roberts intensifies his criticism of the government introducing the phenomenon of excess deaths.
Declaring that there are now 30,000 excess deaths in Australia for the year 2022 alone, this elicited an immediate response from host Professor David Flint who interrupted the Senator, “Could you explain to viewers what an excess death is?”
The Senator responded, “Every year in Australia there are an expected number of deaths, and they vary slightly but because no two years are identification, there is slight variation… and there is a range above and below the mean [number] so it varies,” and the senator demonstrated how a certain number of deaths are expected with some variation above or below the mean number.
So, the point is that the number typically occurs within an expected range, but since COVID-19 and the mass vaccination program the expected death numbers have skyrocketed across much of the developed world.
TrialSite has reported on this number. In fact, this media chronicled in early 2022, that the death rates surged just as the nation’s population became heavily vaccinated which defied expectations.
For example, TrialSite reported in late April 2022 in “Heavily Vaxxed Australia: First 3.5 Months of 2022 has Doubled the COVID-19 Deaths from 2020-2021 Combined.”
Back to the interview, Roberts said, “What we know is that provisional death data shows an excess of 30,000 or more in 2022.”
On the interest of these deaths among the leadership of Australia? Roberts said these people who head TGA, the CMO the secretary of the federal health department “don’t give a damn, there is no inquiry going on as to what is causing these excess deaths. We know, we know from overseas experts, from peer-reviewed scientific papers that it is the injections causing these [excess] deaths. And an alarming level of deaths.”
Why don’t they care? Roberts declared, “I think they are worried about being found culpable for the injections that they have pushed on people and killed people with.”
But contrary to Roberts’ claim there has not been one peer review, scientific study published in a mainstream journal that connects the mounting excess deaths crisis and the mass vaccination program.
Speculation has included COVID-19 itself, and all the problems that come after lockdowns, tight access to healthcare, and the like. But the vaccines are suspect, and Roberts is correct in his assessment that generally, governments are avoiding the topic. That avoidance most certainly signals a set of priorities and values.
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Pfizer mRNA Vaccine Appeared to Trigger Stroke-like symptoms in one patient
Physicians from multiple health centers in Paris, France including Percy Army Training Hospital in Clamart, France in the southwestern suburbs of Paris report on a case series involving a case of subacute lumbosacral NA after the patient received the Pfizer-BioNTech COVID-19 vaccine, called Comirnaty (BNT162b2).
After a thorough diagnosis the French providers concluded that there was no “triggering factor” injuring the 48-year-old patient other than the mRNA-based COVID-19 vaccine—the doctors could not confirm the suspected causation however exhibiting a common trend. Does this reflect a real hesitancy to identify when the vaccine causes harm? Luckily, the patient went into full recovery after treatment with intravenous immunoglobulin.
The French doctor’s report in the journal Revue Neurologique that the individual patient has a recorded history of obstructive sleep apnea syndrome which had been treated with mandibular advancement orthotic with no history of diabetes and no medication.
Summary
The patient was infected by SARS-CoV-2 by March 2020, and later received his first jab of the Comirnaty vaccine on January 20, 2021. Just six days later on January 26, 2021, the authors report:
“The patient experienced a sudden onset of paresthesia in the anterior part of his lower right limb. The symptoms rapidly worsened throughout the day, with anesthesia starting at mid-thigh and extending to the right ankle. These deficits were then followed by neuropathic pain of the right lower limb, for which the patient was put on Pregabalin therapy by his general practitioner and a hospitalization in neurology was programmed. The patient had difficulty walking with weakness of the right lower limb.
On February 11, 2021, the patient received a second dose of Comirnaty© vaccine.”
By April 13, the patient was hospitalized in the hospital’s neurology department. Doctors reported he had “sensory symptoms” plus had difficulty walking which persisted since the jab.
A series of diagnostic measures were taken, along with tests discovering neurogenic aspect when assessing the right vastus medialis and vastus lateralis muscle with electromyography.
Considering multiple conditions including Guillain Barre syndrome, the eventual diagnosis was subacute lumbosacral NA, following a Pfizer SARS-Cov-2 vaccine in a 48-year-old patient.
The diagnosed condition is an issue related to the lower back and sacral region that has a subacute course. Lumbosacral is the region in the lower back where the lumbar spine meets the sacrum whereas subacute means a condition that is intermediate in nature—falling between acute (sudden onset, severe) and chronic (long-lasting) conditions.
The authors report that this 48-year-old patient fully recovered after receiving a regimen of intravenous immunoglobulins. While it would appear that the vaccine is the cause, the authors cannot conclusively state so.
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20 June, 2023
Time to Launch Government-funded Investigations Into the COVID-19 Vaccines
While the COVID-19 vaccines, particularly the mRNA base product developed by both Pfizer-BioNTech and Moderna, became vital tools and countermeasures as part of a global emergency response to the SARS-CoV-2 (COVID-19) pandemic, a lot of problems have been suppressed by a confluence of government, industry and health establishments.
Yes, the Phase 3 mRNA studies showed a remarkable benefit as measured in efficacy, and documents accessed via the Freedom of Information Act (FOIA) suggest a significant surge in vaccine-related side effects. We must remember the COVID-19 vaccines were non-sterilizing and possess questionable durability and breadth. The vaccines were helpful tools during COVID variant surges and overall, the safety record has been decent for most people. The vast majority of these side effects are mild and go away within a few hours to a few days.
However, life is rarely so simple and convenient, and COVID-19 is no exception. A significant number of rare, but real adverse events (AEs) have led to vaccine injury. In fact, TrialSite has tracked enough studies pointing to some connection of the mRNA vaccines to inflammatory actions possibly associated with lipid nanoparticles, used to help deliver the mRNA (payload).
The other culprit for vaccine-related AEs comes as a consequence of the production of the spike (S) protein as well as related subunits and peptide fragments manufacturing across human tissue or organ(s). Much research to date focused on lab tests at the cell or model organism level.
A growing body of evidence points to AEs associated with the COVID-19 vaccines linked to the spike protein, likely associated with molecular mimicry with human proteins or via ACE2 ligand according to some researchers. It's perfectly OK and in fact, part of the scientific tradition to be open, critical and upfront with concerns.
The official medical establishment narrative is as follows: the mRNA vaccines are safe and effective, and that’s the end of the story. Like any vaccine or medication they can have side effects, but these are mostly mild and temporary. But the reality is that no medicine or vaccine is perfect, and in fact, there are no solutions but only tradeoffs, based on multiple considerations such as overall public health.
Serious side effects, however, associated with the mRNA jabs can and do occur. They have been associated with myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) and recently validated in a Korean national cohort study, sudden death in a few extremely rare cases. The most at-risk cohort for these cardiovascular-related risks is young men, typically from the teens up to 30.
Other side effects associated with the mRNA vaccines, although rare, can and do occur and include the presentation of acute myocardial infarction, Bell’s palsy, cerebral venous sinus thrombosis, Guillain–Barré syndrome, myocarditis/pericarditis (mostly in younger ages), pulmonary embolism, stroke, thrombosis with thrombocytopenia syndrome, lymphadenopathy, appendicitis, herpes zoster reactivation, neurological complications and autoimmunity (e.g., autoimmune hepatitis and autoimmune peripheral neuropathies.
Anti-Vaccine activists point to the exponential increase in reported cases of AEs in the Vaccine Adverse Event Reporting System (VAERS), however, the logging of these reports doesn’t automatically prove that the AEs are vaccine-related. Historically, VAERS counts, which are managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration, are undercounted. This means that the actual number of serious adverse events associated with the mass COVID-19 vaccine response in America (270 million primary series in just a couple years) could be far higher than represented in VAERS. But we cannot be sure. As of March 1, 2023, 19,476 deaths are logged in VAERS. Again, this doesn't mean that these deaths are linked to the COVID-19 vaccines (again the vast majority were vaccinated with mRNA-based products).
However, some anti-vaccine activists point out that over 50% are reported within a week or so of the jab, meaning a likely temporal connection. Regardless, over 19,000 deaths represent a lot of deaths possibly linked to vaccines logged in the very system that’s supposed to track incidences. Moreover, VAERS is historically undercounted. But again, as fact-checkers point out in VAERS, correlation does not imply causation — just because an adverse event is reported as having occurred does not mean that a vaccine was the cause.
But based on our ongoing tracking of research around the globe we believe sufficient safety signals are sufficiently present for government investment in specific research to identify the true risks associated with these novel products.
I say novel here because the mRNA vaccines were accelerated due to the declared emergency and completed in 10 months. Importantly, while mRNA research has been going on for a couple of decades, actual commercialization efforts are far newer. For example, Moderna’s own investor disclosures as recent as the end of 2019 acknowledge that these products have never been commercialized and significant risk is consequently attached to the entire research, development and manufacturing initiative. See the link.
TrialSite secured evidence from leaked European Medicines Agency (EMA) emails that at least some prominent employees there were bothered by the pressure to rush the products. Sonia Elijah has reported on this in detail.
We also reported on the avoidance of all required pre-IND enabled studies; biodistribution data accessed via a Japanese FOIA which was given to use by Canadian researchers early in the pandemic.
Additionally, variation in lot quality reported in TrialSite by Sasha Latypova points to potential quality issues in the production of the mRNA vaccines. Sonia Elijah tracked multiple packages of documents released as a result of FOIA. Potential issues are identified.
We are aware of problems directly in the Pfizer clinical trials based on the Brook Jackson lawsuit. While that lawsuit has been tossed by the judge, this author reviewed internal documentation directly involved with that litigation which points to severe quality problems at the Texas-based trial site network (Ventavia).
Any normal study would have been put on hold based on what we reviewed. Multiple media point to grossly inadequate FDA oversight of the mRNA vaccine trials.
While pregnant women were told to get the vaccine by the summer of 2021, they were done so before any regulatory edict. This was seemingly orchestrated between CDC observational data and physician societies focusing on women’s health. Both were concerned with a risk-benefit equation favoring vaccination, but adequate safety data was never produced.
While female rats are a start, it's absolutely outrageous that this class of data was used as evidence to justify the injection of a novel product into a highly vulnerable class of humans. To this day, the FDA package inserts for both Pfizer and Moderna are troubling to say the least. For example, the FDA package inserts for Pfizer’s mRNA Comirnaty as of this writing explicitly declare a lack of data to know whether it's safe or not. See the link. The FDA declares:
“Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”
For studies involving vaccination of pregnant women follow the link to the following TrialSite piece “ACIP Vote Unanimously to Add mRNA-based COVID-19 Vaccine Shots for Children Program.”
We have delineated a timeline of exactly what group recommended vaccination for pregnant women and when. We don’t argue for a conspiracy, but we do argue that herd mentality was at play. Now only investigational products (boosters) are recommended by the FDA. Although, there is an argument that the Pfizer and Moderna mRNA platforms are validated.
Access to other documentation via FOIA such as the CDC’s V-Safe database (thanks to attorney Aaron Siri) pointed to up to 7% of the population receiving the COVID-19 vaccines experiencing an adverse event requiring medical attention. We have acknowledged that the data source can’t prove anything but we don’t summarily discount the data either. While anti-vaccination activists point to the 7% figure as a proxy for vaccine-injured numbers, TrialSite doesn’t agree with this assessment. Our estimation of COVID-19 vaccine injured is far less than anti-vaccine activists. While the latter argues for tens of millions, our estimates at TrialSite suggest anywhere from half a million to 2 million people have been impacted by adverse events which in some way impact quality of life.
Those actually permanently debilitated by the COVID-19 vaccines we believe are a number under 50,000. But this would still be an unacceptable number, demanding not only a government-funded investigation but also a change in vaccine injury compensation policy. Currently, only a handful of people have even been compensated under the government’s Countermeasures Injury Compensation Program (CICP). The average award is under $2,000 dollars and the whole affair is a national disgrace in this author’s opinion. How can there be a mandated policy for a novel medical product (countermeasure in emergency terms) and no viable mechanism to care for people hurt by such a product? What kind of society accepts this? Governments in places like Taiwan and Singapore do a far better job than the United States on this front.
While the majority of investigators in academic medicine line up and report overwhelming safety and efficacy data there are exceptions. We at TrialSite track National Institutes of Health (NIH) awards and record research payments over the past couple of years are allocated to major academic medical centers.
In one study looking at the problem more critically Peter Doshi, and colleagues, all serious physician-scientists, demonstrate based on an extensive review of clinical trials that the mRNA vaccines are “associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI ?0.4 to 20.6 and ?3.6 to 33.8), respectively.
Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI ?3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).”
Does the mRNA spike protein stay in the body or is it expeditiously flushed out of the human body?
According to conventional medical establishment, the mRNA vaccines do not cause the spike protein to say in the body indefinitely. This is generally the case as the mRNA vaccine provides instructions to cells in the body to produce a harmless piece of the spike protein found on the surface of the SARS-CoV-2 virus. This spike protein is then displayed on the surface of the cells temporarily.
The wisdom tells us that the immune system recognizes the spike protein as foreign and mounts an immune response to it. This response includes the production of antibodies and the activation of immune cells. Once the immune response is triggered and the spike protein is recognized, it is broken down and eliminated from the body.
As the logic goes mRNA is a transient molecule that is rapidly degraded within cells. After the spike protein is produced and the immune response is activated, the mRNA from the vaccine is also broken down and eliminated.
Although mRNA is considered a gene therapy, it's not of the type, according to the medical establishment, that alters a person’s DNA or integrates into the genome. The mRNA is supposed to remain in the cytoplasm of the cell, as there it is used as a template to generate the spike protein. Key to the medical establishment’s declaration that the vaccine is not a traditional gene therapy: it doesn’t breach the nucleus of the cell where DNA is based. But make no mistake, TrialSite has verified it's classified as gene therapy by the manufacturers themselves in investor disclosures, directly from the proverbial “horse's mouth.”
While the standard medical establishment understanding means that the spike protein only remains in the body for a temporary period of time, and the mRNA associated with the jabs is rapidly degraded and eliminated, there are plenty of exceptions that are frankly suppressed by the media.
TrialSite supports vaccine injured group React19 to organize the largest data repository of post-COVID-19 vaccine serious adverse event case series, observational and randomized studies. Follow the link for the repository. This is something the federal government should have financed. See the link to access over 3,400 studies.
We have studied enough to know better. There was enormous pressure to not spook consumer markets during the COVID-19 pandemic across local, state and national governments in the U.S, and across other nations around the world. That pressure started in the Trump admin—the POTUS at the time admitted in the Woodward interview that he downplayed the seriousness of SARS-CoV-2, likely for political purposes. Among other problems, this created a cult of COVID-19 denial.
On the other hand, Biden declared a COVID-19 mandate when the science was absolutely clear that the mRNA COVID-19 vaccines were not of the sterilizing variety—meaning they could not reliably stop viral transmission, even though at least in surges of 3 to 12 months they could reduce the probability of morbidity and mortality.
The mandate was clearly unethical, representing some form of power play, and a clear example of executive overreach that the courts recognized in part. We at TrialSite suggest that both Republicans and Democrats politicized the pandemic for their own aims and that the American people are the pawns in a bigger socio-political and economic game. This is one reason for ever more intensive divisive politics—they want us divided and at each other’s throats.
So as long as we have enough readers/subscribers that demand actual objective, unbiased (or as unbiased as possible) news and analysis, we at TrialSite will continue to bring as much transparency and clarity to biomedical and health-related research as possible—our original and only mission, started when we founded and launched the site in late 2018, focused on the translation of complex biomedical research for busy professionals and other consumers interested in research. That mission continues on.
And based on all of the data and analyses we have accumulated over the past two-and-a-half years, not to mention extensive discourse with intelligent experts around the world, we do believe formal investigations must be launched to better understand the true risks associated with the COVID-19 vaccines.
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19 June, 2023
COVID-Vaccinated MORE Likely to Be Hospitalized: CDC Data
There are some problems with inferences here but a complete reversal of the expected result is extreme and seems unlikely to be explained by confounds etc. We may have to allow that the vaccines are more harmful than helpful in the medium term
COVID-19 vaccine effectiveness against hospitalization turned negative over time, according to U.S. Centers for Disease Control and Prevention (CDC) data presented on June 15.
The effectiveness against hospitalization plummeted to negative 8 percent for people who received one of the old COVID-19 vaccines, according to data from a CDC-run hospital network.
A dose of one of the updated bivalent vaccines moved the protection above zero, to 29 percent, but the protection fell back to negative 8 percent beyond 89 days, the data show.
The protection estimates were for adults without a compromised immune system from Jan. 23 to May 24, when the XBB strain was dominant in the United States. The data came from people hospitalized at one of 25 hospitals across 20 states that are part of the Investigating Respiratory Viruses in the Acutely Ill network. Both cases and controls were hospitalized with COVID-like illness but the cases tested positive for COVID-19 and the controls tested negative for COVID-19.
“We see a pattern of waning against hospitalization,” Dr. Ruth Link-Gelles of the CDC said while presenting the data to a U.S. Food and Drug Administration (FDA) panel as they consider updating the composition of the vaccines.
Link-Gelles didn’t specifically comment on how the effectiveness turned negative but noted the wide confidence intervals for some of the effectiveness estimates.
The bivalent vaccines, made by Moderna and Pfizer, were introduced in the fall of 2022 with the hopes of improving protection against hospitalization and death after the old vaccines proved increasingly incapable of providing sustained shielding.
Dr. Robert Malone, who helped invent the messenger RNA technology utilized by the vaccine companies in their vaccines, said that the negative effectiveness is consistent with prior data such as a study from the Cleveland Clinic that found each successive vaccine dose increased the risk of infection.
Other papers have also estimated that protection against infection turns negative over time. Some datasets have indicated that vaccinated people were at higher risk of hospitalization, long seen as a surrogate for severe disease.
Researchers in one recent paper said that repeated vaccination—some Americans have received a half-dozen COVID-19 shots in under three years—weakens immune systems, potentially making people susceptible to life-threatening conditions such as cancer.
The estimates were negative even after CDC officials made adjustments for factors such as age, sex, and ethnicity. The median time since the last dose for the people who only received one or more doses of an old vaccine was 464 days. For the group who received a bivalent vaccine but saw effectiveness turn negative, the median time was 137 days.
Other Data
Data from another network found that protection neared zero over time.
Among adults deemed immunocompetent after XBB became dominant, the protection from the old vaccines against hospitalization was measured at 9 percent in the CDC’s VISION network. A shot of a bivalent vaccine increased protection to 51 percent, but the shielding plunged to 20 percent 90 to 179 days after the shot.
From September 2022 to May 2023, immunocompromised adults in the same network who only received an old vaccine had just 3 percent protection against hospitalization.
A bivalent shot increased the protection to 39 percent, although the shielding was reduced to 11 percent beyond 119 days.
VISION includes sites across 11 states, including Kaiser Permanente Northern California and Columbia University in New York.
Under half of each age group in the United States has received a bivalent dose, including 43 percent of those age 65 and older and 0.6 percent of 2- to 4-year-olds.
The CDC didn’t present data on the effectiveness against infection.
XBB became dominant in the United States in January, displacing BA.5 and its subvariants. The bivalents contain a BA.4/BA.5 component in addition to the Wuhan component. The FDA plans to update the vaccines to target XBB and its sublineages for a renewed vaccine campaign in late 2023 and early 2024.
“We’re concerned that we may have another wave of COVID-19 during the time when the virus has further evolved, immunity of the population has waned further, and we move indoors for wintertime,” Dr. Peter Marks, an FDA official, said during the meeting.
Turn to ‘Critical Illness’
Officials have increasingly been focusing on protection against so-called critical illness, or intensive care unit admission or death, as protection against hospitalization drops lower and lower.
Protection against critical illness from a bivalent was 58 percent initially and only dropped to 48 percent, according to data from VISION during XBB’s predominance.
There weren’t enough critical cases in the Investigating Respiratory Viruses in the Acutely Ill network to provide estimates of protection against critical illness, Link-Gelles said.
She said that patterns of waning with the bivalent vaccines “have been very similar to what we knew from the monovalent vaccine” and that U.S. officials don’t make vaccine policy decisions “based solely on vaccine effectiveness data.”
Limitations of the data include the high levels of prior infection, or natural immunity, and potential differences between unvaccinated and vaccinated people, officials said.
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Chinese Researchers Demonstrate in Lab D-glucosamine Inhibits SARS-CoV-2 and other Coronaviruses
Researchers from the Beijing Institute of Microbiology and Epidemiology, China report in the peer-reviewed journal Nature on the urgent need for the development of broad-spectrum antiviral therapies targeting not only SARS-CoV-2 but also all other coronaviruses, which may either reemerge or emerge for the first time, not to mention mutant variants that can cause so much trouble as humanity discovered during the COVID-19 pandemic.
For example, in China, directed by top-down command and control ethos, this led to extremely costly (both in terms of human health and economy) societal lockdowns, finally changing the so-called “zero tolerance COVID policy” toward the end of the pandemic. In this study involving both infected cells and mice, a dietary supplement with 50 years of use as a regimen against osteoarthritis could possibly, as a supplement administered at daily doses help reduce the impacts of SARS-CoV-2. Of course, more research, including human trials, is needed to investigate the potential of D-glucosamine (GlcN) as a regimen against COVID-19, but the output from this study demonstrates promise.
This research, represented by corresponding authors Chengfeng Qin and Xiaotao Daun, both employed at the Beijing Institute of Microbiology and Epidemiology identified a possible target for broad-spectrum antiviral therapy centering on O-GlcNAcylation, a posttranslational modification derived from hexosamine biosynthetic pathway (HBP), and essential for virus-induced MAVS activation and IFN signaling.
In the lab, the team from the People’s Republic of China identified that a common dietary supplement known as D-glucosamine (GlcN), “enhanced MAVS-mediated IFN signaling, meaning that this low-cost accessible supplement exhibits a broad-spectrum antiviral activity.”
What about applied coronaviruses, however? Before answering that question, a brief overview of D-glucosamine.
What is D-glucosamine?
A naturally occurring amino sugar, D-glucosamine is a building block for various important molecules in the body. It’s a derivative of glucose and is commonly found in the exoskeletons of shellfish, as well as in the tissues of some fungi and microorganisms.
It’s often used as a dietary supplement in support of joint health.
Any studies in humans to date?
Yes. These authors point to a recent clinical study (ClinicalTrials.gov: NCT04706416) reporting that orally administrated N-acetyl glucosamine (NAG), a downstream metabolite of GlcN, decreases the mortality rate and improves clinical outcomes of SARS-CoV-2 infected patients. That was a phase 1 study sponsored by Quantinosis.ai LLC. See the link.
A total of five studies involving D-glucosamine are registered in Clincialtials.gov. They include three complete studies and two active studies. The two active studies include the use of a drug sulodexide which is a mixture of glycosaminoglycans (GAGs) composed of dermatan sulfate (DS) and fast-moving heparin.
The study
The investigational team set up a model for infection based on human lung epithelial cells like Calu-3 and human liver cancer cell line Huh7. The study team used GlcN ultimately at 20mM for 3 h on the Calu-3 or Huh7 cells infected with SARS-CoV-2 at a multiplicity of infection (MOI) of 1.
At 24 hours of infection, the team “observed that SARS-CoV-2 infected cells showed a significantly enhanced intensity of cellular O-GlcNAcylation compared to the non-infected group.”
According to Qin, Duan and their colleagues as conveyed in Nature this observation indicated that SARS-CoV-2 does promote HBP metabolism and protein O-GlcNAcylation in host cells.
Similar to other observations in RSV virus-based infections (e.g., IAV and VSV) they report, “As expected, we found that GlcN significantly increased the cellular level of O-GlcNAcylation and substantially suppressed SARS-CoV-2 replication in infected lung epithelial cells as measured by SARS-CoV-2 spike protein expression.”
The authors further report, “Virus titers in the supernatant were significantly reduced (P < 0.01) in GlcN treatment group.” Additionally, Qin, Duan and colleagues write in their study, “Time course measurements (6 to 24 h post-infection) further confirmed our observation, GlcN treatment significantly inhibited replication of SARS-CoV-2, consistent with titer reduction.”
Moving on, the authors further report the median effective concentration (EC50) value of GlcN against SARS-CoV-2: “GlcN inhibited SARS-CoV-2 infection in Calu-3 cells with a EC50 value of 11.82 mM.”
The authors also conducted an investigation to better understand the viral mechanism of GlcN against the novel coronavirus showcasing intriguing observations that the supplement led to “a considerable increase of both phosphorylated IRF3 and phosphorylated TBK1 and thereby promoted IFN signaling in response to SARS-CoV-2. This in turn decreased the expression of SARS-CoV-2 spike protein in the GlcN treatment group.”
What about the antiviral effect of GlcN against SARS-CoV-2 in vivo? The authors used mice that were infected and treated with the targeted regimen. While the body weight of the orally GlcN-based treatment of mice remained normal, a review of the impact of GlcN against samples of the mice lungs, spleens and livers showed no inducement of systemic IFN response.
The regimen demonstrated potential against at least a couple of other coronaviruses suggesting the potential for application against a broad spectrum of coronaviruses as well.
Overall, the authors report:
“Taken together, this study demonstrated that GlcN enhances SARS-CoV-2 induced IFNs signaling and restricts SARS-CoV-2 replication in multiple human cell lines. In the SARS-CoV-2 infected mouse model, prophylactic administration of GlcN at a clinical-relevant dose significantly reduces the viral load in lung and trachea, and considerably alleviates lung inflammation.”
Summary
This lab study in China demonstrates that GlcN shows potential efficacy against multiple coronaviruses including SARS-CoV-2 in both cell-based and mouse infection models.
The authors remind us:
“GlcN has been clinically applied for the treatment of osteoarthritis for more than 50 years. As a nutrient supplement, orally administered GlcN at daily doses ranging from 750 to 3500 mg is well tolerated in human subjects. Given the safety profile and its broad-spectrum anti-HCoVs activity, GlcN may serve as a promising drug for preventing the spread of SARS-CoV-2 and its emerging variants in healthy populations.”
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18 June, 2023
The Nail in the COVID Coffin
We can now say definitively that the virus came from the Wuhan lab because three named workers were the earliest to become infected.
Granted, the American people have mostly moved beyond COVID-19, both literally and figuratively. But there are still some vital housekeeping matters to take care of — and as of this week, one less of them: We now know definitively, not speculatively, from whence it came. As independent journalists Michael Shellenberger, Matt Taibbi, and Alex Gutentag write on Substack:
After years of official pronouncements to the contrary, significant new evidence has emerged that strengthens the case that the SARS-CoV-2 virus accidentally escaped from the Wuhan Institute of Virology.
According to multiple U.S. government officials interviewed as part of a lengthy investigation by Public and Racket, the first people infected by the virus, “patients zero,” included Ben Hu, a researcher who led the WIV’s “gain-of-function” research on SARS-like coronaviruses, which increases the infectiousness of viruses.
“Strengthens the case”? These gents are being too modest. This closes the case and puts a nail in its coffin, to mix our metaphors. It’s one thing to identify the Wuhan lab as the source of the deadly scourge, but it’s another thing entirely to name individual names, which is what this new report does: the aforementioned Ben Hu, and Yu Ping, and Yan Zhu. These are three of the earliest people to become infected with SARS-CoV-2, and they all worked at the Wuhan Institute of Virology.
B-b-b-but, but, they could’ve all been shopping for some fresh dog or pangolin at that nearby wet market!
Yeah, right.
This, of course, isn’t the first time that anyone has claimed COVID-19 came from a lab. Heck, this humble correspondent has been claiming it for years. And doubling down on it.
As for those apologies, we aren’t holding our breath. Still, it’s instructive to remember just how wrong these people have been proven to be. Even lefty Jon Stewart, who came out of retirement to address his people’s Krazy Glue adherence to the theory that a bat flew into the cloaca of a turkey and resulted in the deaths of — depending on who’s counting — more than 1.1 million deaths in the U.S. and nearly seven million deaths worldwide.
It’s also worth remembering the evolution of the blame. As first, everyone was calling it “the Wuhan coronavirus.” But then the ChiComs put the arm on their leftist fellow travelers here in the U.S., and pretty soon it became racist to imply that the Wuhan coronavirus was in fact the Wuhan coronavirus. Take a look.
But merely identifying the Wuhan lab and its earliest victims isn’t the end of it. There’s also the matter of the Chinese military’s involvement. As Shellenberger writes elsewhere on Substack: “You may recall that The New York Times called Robert F. Kennedy a ‘conspiracy theorist’ for saying Covid resulted from a bio-weapons program. And yet one of the State Department cables [which were recently obtained via a FOIA request] shows a connection between China’s biotechnology sector and the Chinese military (People’s Liberation Army), which included its construction of the Wuhan lab.”
The ChiComs’ military involvement in COVID-19 gained momentum earlier this week, when the UK’s Sunday Times published a bombshell report about it. As our Nate Jackson wrote:
Researchers “were combining the world’s most deadly coronaviruses to create a new mutant virus,” the Times says. This gain-of-function research using viruses collected from bats was funded in part with U.S. taxpayer money funneled from the National Institutes of Health (NIH) through EcoHealth Alliance, which almost certainly lied to keep the funding coming, and conducted by “researchers from the Chinese military” who were “pursuing bioweapons.”
We wonder: Will the commie apologists affix the “RACIST!” label to those of us who are now suggesting, with ever-increasing evidence, that the Red Chinese military is behind all this? Time will tell. And time will tell whether the ChiComs will pay any real price for what they’ve done. (By the way: How is it racist to think that the Chinese are both intelligent enough to develop a deadly virus and stupid enough to accidentally leak it, but it’s not racist to accuse them of shopping at these weird wet markets and eating dogs and bats and pangolins and hedgehogs?)
National Review’s Jim Geraghty reminds us what happened to an honest Chinese doctor who tried to alert the rest of the world to what was happening back when it could’ve saved millions of lives:
The problem was that when those doctors tried to pull the alarm, the local, regional, and national Chinese government authorities above them kept shutting down their efforts until it was too late. Dr. Li Wenliang got dragged into a police station and was berated for “rumormongering” and for “publishing untrue statements,” and threatened with prosecution. A little more than a month later, the virus that he had desperately tried to warn his countrymen and the world about killed him.
Earlier in the week, Geraghty noted an exhaustive Times of London piece which leads folks to a single inevitable conclusion — or one of two conclusions, if you’re a dead-ender who can’t agree with Donald Trump under any circumstances: “Either Covid-19 plagued the globe because of an accident at the Wuhan Institute of Virology in late 2019, or an absolutely remarkable series of coincidences, against overwhelming odds, led to a virus that has never been found in nature infecting a human being just down the road where the WIV was doing gain-of-function research on the virus in nature that is most similar to SARS-CoV-2.”
The question now is: What are we going to do about it — not only with respect to the Chinese, who have yet to atone for it, but also regarding those here in the U.S. who went to such extraordinary lengths to defend the purveyors, to hide the truth, and to rewrite history?
As blogger and public health expert Michael Hanna writes, “The most troubling part for me is knowing that this will likely happen again, and again — unless some very nasty consequences are brought to bear for those who knowingly or unknowingly enabled this unmitigated disaster in funding and oversight of biohazardous research.”
https://patriotpost.us/articles/98113
****************************************************US presidency through the Covid lens
We stand at a Covid cross-roads. On one side, there is by now a wealth of studies demonstrating the negligible benefits of the key pandemic interventions. In May the US finally ended its ban on unvaccinated foreigners’ entry into the country. A study by Kevin Bardosch looked at 600 publications using a ‘harm framework’ to conclude that ‘the collateral damage of the pandemic response was substantial, wide-ranging and will leave behind a legacy of harm for hundreds of millions of people in the years ahead’, exactly as many of us warned from the beginning. In June a major peer-reviewed meta-analysis of 20,000 studies from the Institute of Economic Affairs by US, Swedish and Danish researchers concluded that, regarding stringent lockdowns, in the words of co-author Steve Hanke, ‘the lives saved were a drop in the bucket compared to the staggering collateral costs imposed’.
On the other hand, there remain many disquieting indicators of the continuing hold that the failed and discredited narratives have on policymakers and publics to suggest that the insanity could be repeated at short notice. For example, Biden’s pick as the new CDC director, Mandy Cohen, is a lockdown, mask and vaccine fanatic. On 14 August 2020 she tweeted a photo of herself wearing a mask imprinted with a portrait of the execrable Anthony Fauci. Many of the worst offenders on lockdown, masks and vaccines have been honoured with gongs while the likes of Oxford University’s Carl Heneghan and Stanford’s Jay Bhattacharya were monitored by the government’s Counter-Disinformation Unit and heavily censored on social media. Governments remain stubbornly resistant to investigating the concerning phenomenon of excess deaths. The WHO and the European Commission have launched a digital health initiative for creating global vaccine passports. The WHO effort at expanded powers to rule over the world through a new treaty and/or amended international health regulations remains on track.
President Dwight Eisenhower’s warning, in his farewell address of 17 January 1961, of ‘the military-industrial complex’ is one of the most quoted phrases of any US president. In the same speech, he also warned of another danger: ‘The prospect of domination of the nation’s scholars by Federal employment, project allocations, and the power of money’ such that ‘public policy could… become the captive of a scientific-technological elite’. The lens of how various leaders managed the pandemic therefore helps us to frame the contest in terms of their respective culpability in enabling and facilitating the grave attacks on freedoms, versus their capacity and willingness to resist and reverse the blanket of authoritarianism that has suffocated liberal democracies since 2020.
Because of the dominant influence of America on the rest of the democratic world, the US presidential contest has unique global resonance. Lord Sumption, the former UK Supreme Court justice, said in May 2020 that ‘the lockdown is without doubt the greatest interference with personal liberty in our history’. On 18 May US Supreme Court Justice Neil Gorsuch echoed Sumption: ‘Since March 2020, we may have experienced the greatest intrusions on civil liberties in the peacetime history of this country’.
In this perspective, the ideal Republican and Democratic champions would be Ron DeSantis and Robert F. Kennedy Jr. No one else comes close in the two parties to their record in forceful opposition to lockdowns, masks and vaccines. For them to triumph in the primaries would mean the campaign will be a referendum on Covid, the resistance heroes win the public debate, and the new president has a clear mandate to revert to pre-Covid normality. At present both are miles behind the two front-runners Trump and Biden in the RealClearPolitics poll of polls and betting averages. However, both DeSantis and Kennedy are well clear of other candidates. Considering both have only recently declared, this is an impressive solid base on which to build.
Democrats have been unsettled by the high profile and surging support for Kennedy. On many character and judgment attributes, voters rate Kennedy higher than Biden. In the Echelon poll in May Kennedy scored a massive 40 per cent net favourability advantage over Biden. Little wonder Republican political consultant Douglas MacKinnon believes that Kennedy will be the Democratic nominee. Of course, the media continues to smear Kennedy for kooky conspiracy theories even as many have come true. But he has name recognition, speaks with passion and gravitas and as an experienced trial lawyer, has good debating skills.
In DeSantis, Trump faces the most successful, best funded and best prepared intra-party opponent of his political career. DeSantis gained national profile for turning a marginal victory in 2018 into a landslide in 2022, colouring America’s biggest swing state from rosé to ruby red. Many Americans applaud DeSantis for the fightback against the metastasising woke ideology. He famously declared ‘Florida is where woke goes to die’. Good leaders pick highly capable aides and work well with them over many years. Trump is notable for the rapid churn of most of his hand-picked senior aides. He demands total loyalty but gives none in return. For most of this year, the focus of Trump’s ire and schoolyard insults has been DeSantis. The Republican base loves DeSantis, if less than Trump, and reviles former New York governor Andrew Cuomo. In his desperation to wound DeSantis on Covid management, Trump has gone full-on Cuomosexual, besties with benefits. Because Cuomo is toxic among diehard Republicans, Trump risks damaging his own standing with them.
In a one-minute video rant, Trump accused Florida of having the third-worst Covid death rate in the US. ‘Even [former New York governor Andrew] Cuomo did better, he was number 4’. Put aside the fact that Trump himself moved to Florida. On the raw figures, the US national average is 352.5 Covid deaths per 100,000 people. Florida is tenth-worst with 412.1 deaths/100k and New York ranks 16 with 399.1 deaths/100k. But the CDC’s state-by-state analysis of age-adjusted Covid mortality (a more accurate mortality metric) gives the national average as 282.9. Florida ranks a lowly 36 among the 50 mainland states with 245.2 compared to New York’s 311.7 that put it at number 17. Trump’s instincts may have been libertarian but he allowed himself to be manipulated into policies that have produced disastrous consequences. DeSantis attacked Trump for turning over the country to Fauci in Match 2020 that ‘destroyed millions of peoples’ lives’.
Trump’s federal indictment on 9 June for holding classified documents throws a wrench into all calculations: will it derail his candidacy or solidify support in anger at the Democrats’ weaponisation of the criminal justice system?
https://www.spectator.com.au/2023/06/us-presidency-through-the-covid-lens/
********************************************************16 June, 2023
mRNA vaccines fast-tracked for Australian agriculture
After the spectacular failure of mRNA vaccines in human trials, the agricultural industry is pushing ahead with mRNA vaccines for livestock engaged in the food industry.
Whispers of stock ‘dying suddenly’ will no doubt become a complaint of farmers in the future, summarily ignored by government in the same way officials refuse to listen to serious concerns about dam-building restrictions, price hikes on Ag products, ridiculous fees and charges, incomprehensible red and green tape, biosecurity regulations that do nothing, and – fresh out of Western Australia – expensive negotiations with Indigenous groups who have never set foot on the land they claim to ‘own’.
In one example that mRNA is on its way Down Under, on May 2, 2023, Meat and Livestock Australia (MLA) announced funding for a project to ‘test mRNA vaccines that can be rapidly mass-produced in Australia in the event of a lumpy skin disease or other exotic disease outbreak’.
The Manager for Animal Wellbeing, released a statement saying:
‘This project will develop a mRNA vaccine pipeline initially for LSD, but potentially for other emergency diseases. This will enable capacity for rapid mass production of a vaccine for LSD in the event of an outbreak. No LSD vaccines are registered for use in Australia yet. While some vaccines exist overseas, the path to registration in Australia for traditionally-produced [vaccines] is longer than that of an mRNA vaccine.’
Why are traditional vaccines, which have safety records that outstrip mRNA vaccines, subject to longer approval periods than mRNA vaccines? That sounds like a significant structural failure within Australia’s health body that, instead of being fixed, has the potential to be exploited by manufacturers looking to cash in on mRNA.
mRNA vaccines are quick to produce and ‘nimble’, which is why pharmaceutical companies like them – but that doesn’t mean that they are safe, effective, or suitable for consumers whether those are humans or livestock.
A 2022 article in PubMed Central notes: ‘Recently, the successful application of mRNA vaccines against Covid has further validated the platform and opened the floodgates to mRNA vaccine’s potential in infectious disease prevention, especially in the veterinary field.’
No doubt this is why we keep hearing bleatings of ‘emergency’ and ‘outbreak’ in the same breath as mRNA, as if to remind us of the mantra used during the Covid era to embark on what the former Health Minister referred to as the ‘largest clinical trial – the largest global vaccine trial ever’. Look how that turned out.
The fall-out of Covid mRNA vaccines is likely to continue for the best part of a century as a percentage of vaccinated individuals ‘die suddenly’ or suffer from long-term debilitating illnesses. These are quickly becoming a burden for the health industry and state finances after vaccine manufacturers hand-waved responsibility because it was an ‘emergency’. Most nations are setting up compensation pools of cash to cope with the growing list of individuals who claim to have been harmed.
Another excuse used to feather the nest of mRNA vaccines is that they are thought to provide the solution for influenza-style viruses which traditional vaccines have proven ineffective against. Everyone wants to see an effective vaccine against respiratory viruses, but it’s almost as if the doe-eyed vaccine industry has put on a blindfold for the last three years. mRNA Covid vaccines did next to nothing to combat or control the influenza-style Covid and do not, based on what we have seen, offer any advantage to traditional vaccines for this problem beyond the feel-good marketing headlines. There is a strong argument that for the majority of the population, they did more harm than good.
Instead of suspending all mRNA vaccines until we understand what went wrong, they are being given priority treatment by regulators and championed by manufacturers who love the competitive edge of speed their production offers. Governments, particularly the (broke?) Victorian state government, are funnelling tens of millions into mRNA development to keep capitalising on the political popularity they enjoyed during the Covid era.
MLA note that mRNA vaccines should be ready for use within two years and while everyone is busy stressing that this will be a ‘voluntary’ option for the farming community, vaccines inside the agricultural industry rarely are if a producer wishes to sell their product into domestic and international markets. If we go down the mRNA vaccine production line, it is extremely likely that Australians will be eating mRNA-vaccinated livestock within a couple of years with very little understanding of what this will mean health-wise.
Anyone who criticises mRNA vaccines or their potential future within the agricultural industry are paraded through the press as ‘conspiracy theorists’ with publications quick to send out the fact-checkers to insist that it’s pure fear-mongering to suggest fragments of these vaccines will end up in the food chain.
Except, it was a ‘conspiracy theory’ to suggest that the human body would continue making Covid mRNA vaccines long after the injection, or to raise concerns that it would leave the site of the injection. Not only did the fears described as ‘conspiracy’ prove to be true, the behaviour and side effects of Covid mRNA vaccines are reaching well beyond what anyone predicted.
How sure are we that in the rush to saturate the market with mRNA vaccines, that proper long-term testing will be conducted, particularly when it comes to lingering in meat and milk? Will it impact high-risk activities such as calving, given there is a strong suspicion that Covid vaccines are responsible for a spike in human miscarriages?
Keep in mind that we are still being told Covid vaccines are ‘safe and effective’. The Australian government, sitting on a pile of unwanted vaccines, is spending public money on marketing campaigns, encouraging Australians to go and get their booster shots at the same time other countries have removed Covid vaccines.
At least some States in the US are taking note, rushing to pass legislation to ban the use of mRNA vaccines for animals involved in the food industry whose meat or milk is produced for human consumption. Idaho is one example where it will be a misdemeanour to use mRNA vaccines – and that includes the Covid vaccines.
Australians need to be aware that mRNA vaccines are coming for the agricultural industry and they will likely be compulsory. America is having a serious conversation about whether this should be allowed, and Australia needs to do the same thing. It is perfectly reasonable to require extensive long-term safety data before we revolutionise agriculture.
This conversation will not happen on its own. Australia’s agricultural elite resemble a body of yes-men nodding furiously toward mRNA. Family farmers – disempowered, constrained, and demoralised – have no voice in this matter. Their wishes will be bulldozed by a small collection of billion-dollar farming entities, several of which are foreign-owned.
If Australians care about what they eat, it’s time to start making a racket.
https://www.spectator.com.au/2023/06/mrna-vaccines-fast-tracked-for-australian-agriculture
************************************Vaccine advisory group to meet, including vaccine critics
Current vaccines of little use
TrialSite has reported that this week, the Food and Drug Administration (FDA) Vaccines and Biological Products Advisory Committee (VRBPAC), a group of independent experts in the fields of virology and vaccinology, will meet tomorrow, Thursday June 15 from 8:30AM to 5:00PM ET, accessible via YouTube.
Among other presenters and speakers will be David Wiseman, Ph.D., a frequent TrialSite contributor and critique as to how government agencies such as the FDA have conducted its affairs during the pandemic. TrialSite has reported how both the World Health Organization (WHO) and the European Medicines Agency (EMA) and the European Centers for Disease Prevention and Control (ECDC) have made the call to accelerate the move away from the current COVID-19 vaccine formulations to more relevant Omicron strains such as those associated with XBB lineages.
TrialSite wrote and warned frequently during the early parts of the mass countermeasure roll out that it would be difficult to impossible to control SARS-CoV-2 with vaccines. A dynamic, mutating RNA virus, the pathogen drastically changed over the last couple years, emerging as not only more transmissible but also less severe. The pathogen increasingly evaded the defensive powers of the COVID-19 vaccines.
The FDA’s briefing artifacts point to a comparable direction for the American vaccine regulator. TrialSite reviewed the artifacts, finding that Pfizer, Moderna and Novavax need to advance formulations, becoming monovalent again, targeting the Omicron XBB sublineages with an emphasis on XBB.1.5, XBB.1.6 or XBB.2.3. The FDA now embraces a process comparable to how the specific annual influenza vaccine is selected.
The current COVID-19 vaccine in use in America, the bivalent booster (index strain plus Omicron BA.4/BA.5), has emerged as the only vaccine product recommended by the FDA. But there is just one problem: The strains that this vaccine targets are basically extinct. The quality of this product as measured by durability and breadth of effectiveness is questionable---at least this is the case according to TrialSite. Also as TrialSite’s founder recently argues for in an opinion piece, the government should invest in more detailed safety reviews.
So, expected at tomorrow’s meeting is that a strain will be selected, and then the pharmaceutical companies of Pfizer-BioNTech, Moderna and Novavax will be expected to update their platforms with the targeted updated strains. Importantly, as is the case with WHO, EMA and CDC, the pharmaceutical vaccine makers will not have to revalidate their platforms. This means that human clinical trials data will likely not be required assuming a sufficient collection of prespecified data meeting key targets are provided by the vaccine makers before authorization by the agency. However, this process has detractors, such as Dr. David Wiseman, who argues changes to formulation have included material modifications to the vaccines necessitating validation—meaning extensive clinical trials to verify efficacy and safety.
The current bivalent BA.4/BA.5 vaccine now streamlined as the only option in America based on a handful of studies affords only nominal to slightly improved neutralizing antibody protection against current predominant SARS-CoV-2 Omicron strains such as XBB and XBB.1 than compared to three doses of the original monovalent jab.
Moreover, the bivalent jabs met significant hesitance among the American healthcare market, COVID-19 or not. Americans were increasingly hesitant due to a confluence of factors including concerns about vaccine quality and safety. Under 20% of the eligible population opted to even receive the jab.
By February of 2023, the CDC reported that the XBB 1.5, an Omicron lineage, emerged as the predominant SARS-CoV-2 pathogen in circulation. First detected in October 2022, by May 2023, the University of Nebraska reported XBB.1.5 emerged with 53.8% of all cases, followed by XBB.1.16 with 15.1% of cases, and XBB.1.8.1 with 11.8 of cases. According to Dr. Mark Rupp, “The original omicron variant is gone now.”
The FDA has noted in the past that “intrinsic viral factors” such as rate of mutation and recombination potential suggest greater transmissibility and adaptation to the human host while host immune response and a confluence of other forces may contribute to selection of variants. An outspoken critic, Belgium vaccine specialist Geert vanden Bossche has gone on the record that it was a mistake to conduct a mass vaccination in the middle of a pandemic. While the conventional wisdom of medical and scientific establishments, often unduly influenced by industry, points to the vaccines saving millions of lives.
********************************************************
15 June, 2023
Wuhan lab engineered dangerous mutant coronaviruses, worked with Chinese military to develop bioweapons and pre-pandemic COVID vaccines, according to eye-opening report
Scientists at the Wuhan Institute of Virology in China were intentionally merging dangerous coronaviruses to create new mutant viruses just before the COVID-19 pandemic began, according to a new report. At the same time, the Chinese military was pursuing biological weapons while also funding researchers at the Wuhan lab, investigators reportedly said.
"As the world emerged from lockdown, U.S. State Department investigators were given access to secret intelligence on what had been happening in China in the months and years before COVID emerged," the report read. "More than a dozen investigators were given unparalleled access to 'metadata, phone information and internet information' from intercepts collected by the U.S. intelligence services."
The Sunday Times spoke with three members of the investigative team, which determined: "Wuhan scientists were conducting experiments on RaTG13 from the Moijang mine, and that covert military research, including laboratory animal experiments, was being done at the institute before the pandemic."
The source claimed that scientists at the Wuhan lab were working on nine different COVID variants.
In 2012, six men clearing an abandoned copper mine in the Mojiang region of south China were infected with a mystery illness, that had symptoms of fever, coughs, and pneumonia. Three of the men required treatment at a hospital and later died. The men did not test positive for any known illnesses, but did have antibodies for an unknown coronavirus.
The cave in Mojiang had a large bat colony, and the cave was littered with guano – bat feces.
A virus was recovered from the cave in the remote mountains of Yunnan province in southern China. The discovery was made by the team led by Dr. Shi Zhengli – a top Chinese researcher at the Wuhan Institute of Virology, who was known as China's "bat woman."
Around 2018, the Wuhan Institute of Virology reportedly began combining SARS-like viruses with the cave virus labeled as "WIV1," using the Wuhan lab's initials. Rutgers University Professor of Chemical Biology Richard Ebright described the project as the most dangerous coronavirus experiment ever undertaken.
The combination of viruses killed 75% of the albino mice with human-like lungs that were infected with – three times as lethal as the original WIV1.
The Sunday Times stated, "The scientists had created a highly infectious super-coronavirus with a terrifying kill-rate that in all probability would never have emerged in nature. The new genetically modified virus was not COVID-19 but it might have been even more deadly if it had leaked."
The gain-of-function experiment was partially funded by EcoHealth Alliance's grant money. However, documents obtained by the Freedom of Information Act show that the deaths of the infected mice were not mentioned in an April 2018 progress report to the NIH by EcoHealth Alliance's president Peter Daszak.
Daszak reportedly applied for more funding, and asked for $14 million over three years from the Defense Advanced Research Projects Agency. However, DARPA rejected the application to fund the research.
"The application, entitled Defuse — which names Daszak, Shi and Baric — proposed the Wuhan laboratory find large numbers of new SARS viruses and mix some of them with their two deadly strains from the Shitou cave — WIV1 and SHC014 — to see what would happen," the Sunday Times said.
In November 2019, several researchers at the Wuhan Institute of Virology purportedly got sick and were taken to a hospital with symptoms similar to COVID. A relative of one of the laboratory workers allegedly died from the same mystery illness.
"We were rock-solid confident that this was likely COVID-19 because they were working on advanced coronavirus research in the laboratory," an investigator said. "They’re trained biologists in their thirties and forties. Thirty-five-year-old scientists don’t get very sick with influenza.”
At the time of the outbreak, which was a month before the West was made aware of the mystery virus, researchers at the Wuhan lab were conducting dangerous experiments, according to the Sunday Times, citing two U.S. researchers who collaborated with the Wuhan Institute of Virology.
The investigators also saw evidence that the institute was conducting “serial passaging” experiments on at least one of the mine viruses. This is a process in which lab animals are infected with viruses and monitored to see which strain is harmful to their health. The most damaging strain is selected for repeat experiments to encourage the pathogens to mutate into something more deadly.
The investigators spoke to a Wuhan institute insider who alleged serial passaging experiments were being carried out on RaTG13. “Humanized mice with the serial passaging is a toxic combination,” said a source. “It speeds up the natural mutation process. So instead of taking years to mutate, it can take weeks or months. It guarantees that you accelerate the natural process."
Dr. Steven Quay, a U.S. scientist who advised the State Department on its investigation, said, "There has never been an example of a bat virus directly infecting humans and killing."
Quay believes COVID-19 was created by inserting a furin cleavage site into one of the mine viruses and then serial passaging it through humanized mice. He submitted a statement to the U.S. Senate explaining the process. “You infect the mice, wait a week or so, and then recover the virus from the sickest mice. Then you repeat. In a matter of weeks this directed evolution will produce a virus that can kill every humanized mouse.” This explains why from the beginning of the outbreak, he says, the pandemic virus was so remarkably well adapted to infect humans.
The Sunday Times noted that there is no published information about the experiments because it was a top-secret program funded by the Chinese military. U.S. State Department investigators determined that the Wuhan Institute of Virology had conducted experiments on behalf of the Chinese military since at least 2017.
The report stated, "The investigators believe the Chinese military had taken an interest in developing a vaccine for the viruses so they could be used as potential bioweapons. If a country could inoculate its population against its own secret virus, it might have a weapon to shift the balance of world power."
A U.S. investigator told the British outlet, "My view is that the reason Mojiang was covered up was due to military secrecy related to [the army’s] pursuit of dual use capabilities in virological biological weapons and vaccines."
The Sunday Times reported:
The PLA had its own vaccine specialist, Zhou Yusen, a decorated military scientist at the academy, who had collaborated with the Wuhan scientists on a study of the MERS coronavirus and was working with them at the time of the outbreak. Suspicion fell on him after the pandemic because he produced a patent for a COVID vaccine with remarkable speed in February 2020, little more than a month after the outbreak of the virus had first been admitted to the world by China.
A report published in April, co-authored by Dr Robert Kadlec, who was responsible for the U.S.’s vaccine development program, concluded that Zhou’s team must have been working on a vaccine no later than November 2019 — just as the pandemic began.
Zhou died in May 2020, at age 54.
https://www.theblaze.com/news/wuhan-lab-leak-chinese-military-covid
**************************************************Back to the Future of COVID-19--Event at White House Requires Unvaxxed to Don a Mask
Yes, the pandemic and its corresponding emergency ended last month. Yes, the Omicron variant of SARS-COV-2, overall, has far less severe impacts as measured in number of hospitalization and mortality cases than previous COVID-19 surges. And yes, the science is quite clear at this point that the COVID-19 vaccines are not sterilizing, meaning they do not stop viral transmission in any predictable manner and hence, do not control the pathogen’s spread in any expected way. The jabs are associated with reduced morbidity and mortality. No, the news, apparently, hasn’t hit the Biden White House. Evidencing such a reality, according to multiple reports, a group of NCAA athletes were invited to the White House by President Joe Biden, accompanied by first lady Jill Biden to attend “College Athlete Day” on June 12. In association with this event, members of Congress were invited to attend by the White House’s Office of Legislative Affairs. The lawmakers had to get a COVID-19 test in advance of the event and if they were unvaccinated, they were required to wear a mask, according to a Fox News account.
This news allegation brought back the spring of 2021. During that time, while TrialSite was already reporting on studies evidencing the prospect of breakthrough infection due to the combination of a mutating pathogen and COVID-19 vaccine durability challenges, the Centers for Disease Control and Prevention (CDC) director Rochelle Walensky told Americans that if they got vaccinated with one of the COVID-19 vaccines they could lose their masks—vaccinated persons no longer would be required to wear the mask indoors or outdoors in a majority of circumstances.
Yet by late July, the CDC reversed that decision, declaring again that fully vaccinated people in the U.S would need to wear a mask against, at least in doors in locations where COVID-19 transmission rates were high. Why the reversal? Among other things, the durability challenges associated with the vaccines were now apparent in the unfolding science.
Fast forward to June 12, 2023, and regardless of the facts delineated at the top of this article, while the members of Congress attending the event don’t need to take a COVID-19 test, they do need to come masked and prepared to socially distance themselves.
According to Fox News, the email invitation declared:
“Masking Guidance: Fully vaccinated guests are not required to wear a mask on the White House grounds. Guests who are not fully vaccinated must wear a mask at all times and maintain at least 6 feet distance from others while on the White House grounds.”
This decision represents a political one for the most part. While some fear of COVID-19 lingers, the organizers of this event, or some influential group within the White House, wants to reinforce the value of the COVID-19 vaccines.
SARS-CoV-2 emerges as a pathogen comparable to influenza. This comparison is now made by both the World Health Organization as well as the CDC when it comes to planning ongoing vaccination schedule planning. During flu season, is it normal at all to segregate those persons that received their flu shot from those that did not—and demanding that the latter wear masks. When will people wake up to the ludicrous, divisive nature of these actions?
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13 June, 2023
The Clash of Truth and Power: Exposing the Underbelly of COVID-19 Censorship
While Twitter’s Yoel Roth was reluctant to shut down accounts on the basis of a false Russian disinformation narrative, those kinds of hurdles were no longer a problem when COVID arrived. If it was in the name of COVID, anything went, no questions asked.
In fact, in some cases, the government did not even have to ask. For instance, it wasn’t Anthony Fauci who reached out to Facebook. It was Facebook that reached out to Fauci.
On March 15, 2020, one day before “15 days to slow” the spread was announced, Facebook’s Mark Zuckerberg emailed Fauci to propose collaboration between Fauci and Facebook on putting out what Zuckerberg called “authoritative information from reliable sources.”
Fauci responded favorably and so Facebook’s COVID censorship regime in coordination with Fauci was born.
That regime entailed “not allow[ing] false claims about the vaccines or vaccination programs which public health experts have advised us could lead to COVID-19 vaccine rejection”
And it wasn’t just vaccines. Posts about hydroxychloroquine were also censored by Facebook, not because it was best practice but because that was the government line supported by Fauci. The same happened with Ivermectin.
Recall that getting the mRNA vaccines approved in fast track mode was only legally possible if there were no other treatments available. It is no wonder then that government actors such as Fauci and social media giants such as Facebook made sure that even just talking about alternative treatments was effectively forbidden.
The censorship regime grew so quickly and so wide that preeminent epidemiologists such as Jay Bhattacharya were not only silenced for their views but called “fringe epidemiologists”– by the head of the National Institutes of Health no less.
What was it that Bhattacharya said that got him and his colleagues that label? It was the Great Barrington Declaration which, as we know now—and many knew back then—merely stated mainstream epidemiological doctrine. There was nothing fringe about it whatsoever.
But the label worked and Bhattacharya and his colleagues Martin Kulldorff and Sunetra Gupta were ostracized from the scientific community and by the media.
Ironically, the Great Barrington Declaration is now widely accepted as the common sense approach to COVID. But when it mattered, the government, the media, and social media censored any mention of it.
We at The Epoch Times strongly rejected this and went in the other direction. We were among the first to give alternative voices a platform to be heard.
We had some experience with this from the Russia collusion saga where we were also among the first media outlets to pursue the real facts and not the Washington, D.C. narrative. Everything we wrote at that time has now been vindicated by the Durham Report which was published earlier this week.
The same can be said with respect to COVID. We were the first to report on many stories that were being censored by the corporate media. Lockdowns, masks, vaccines, and so on. I did not know Jay Bhattacharya and Martin Kulldorff before COVID. We got to know each other because they resisted the censorship and Epoch was open to their ideas.
The Epoch Times also produced a documentary on the origin of COVID which was first broadcast on April 7, 2020, just as Anthony Fauci had started pushing his natural origin narrative.
I’ve just rewatched our documentary and looking back, we got almost everything right about the Wuhan lab. In fact two days after we first broadcast the documentary, the director of Anthony Fauci’s stateside lab at Galveston, a man called James Le Duc, who also happened to have personally trained Wuhan lab staff, started privately discussing our documentary with colleagues. They were all very much aware that the pandemic likely started at the lab.
So while Epoch was being chastised as a conspiracy theory outlet, the people at the center of the affair were privately discussing that Epoch was putting out the facts. It took years of FOIA litigation to obtain the emails of these public health officials which is how we know that their private views were the opposite of their public views.
Sadly, it was during this time that we were demonetized by YouTube—which is another indicator of the huge toolkit that tech giants have in controlling speech.
While I’m on the topic of YouTube, I can also share with you that we used to upload rough cuts of some of our upcoming shows on YouTube as a convenient way to collect comments from contributors. These videos were unlisted and not public. Only a few people had access. Yet when the videos talked about vaccines or masks, YouTube would take them down.
I don’t think we had a personal censor, it’s just that the algorithm scanned these videos, found that it contained certain forbidden words and so they were taken down. That’s the pernicious impact of technology.
Which brings us back to the First Amendment. A hundred years of American jurisprudence has maintained that in a free society speech must be free, even if it is untruthful.
As recently as 2012, Justice Anthony Kennedy—in United States v. Alvarez—affirmed that “The remedy for speech that is false is speech that is true …. This is the ordinary course in a free society. The response to the unreasoned is the rational; to the uninformed, the enlightened; to the straight-out lie, the simple truth.”
If the Great Barrington Declaration was unreasoned and uninformed, well, then free speech would have exposed its defects.
But there were no defects, which is why it had to be aggressively suppressed instead. That is the lesson here. Speech is not suppressed because it is wrong, it is suppressed because it interferes with someone’s agenda.
So what was the agenda and why did the government, the media, and social media rally around this one agenda rather than let alternative voices on COVID be heard?
There are of course many factors and many theories. Take Fauci for instance. He had many reasons to push a false narrative on COVID. For one thing, he knew there was a strong likelihood that his funding of the Wuhan Institute of Virology had caused the pandemic in the first place.
But he had other reasons too. Fauci’s entire career had been centered on discovering universal vaccines. This is why he was pushing gain-of-function experiments. COVID was a once in a lifetime opportunity to fast track an entirely new genre of vaccines and to do it on a global scale. Correctly pointing out that COVID was not particularly dangerous for large swathes of the population, or highlighting the existence of alternative remedies, stood in the way of Fauci’s universal vaccine ambitions.
But that’s just Fauci. Why did everyone else jump on the bandwagon, casting aside a hundred years of not only medical science but also of hard earned civil liberties?
I think to answer that, we have to go back to Trump. When I talked about the beginnings of the government censorship regime, I did not only do so for historical context but also to show how Trump—specifically a deep dislike of Trump among the Washington, D.C. Beltway crowd—drove these efforts.
And I think it was that same motivation that drove many of the COVID censorship efforts. That’s not to say that there would have been no COVID censorship without Trump but dislike of Trump was certainly the glue that allowed all these various forces to coalesce.
When Trump said the virus came out of the Wuhan lab, there was an instant push toward the opposite narrative. When Trump said to try hydroxychloroquine, there was an instant push to outlaw off-label use of it. When Trump said to reopen the economy, the entire media complex aggressively pushed against that.
You get the point. Again and again, the forces of censorship were united by their dislike of Trump.
So how do we stop it from happening again?
One of the things that the pandemic starkly exposed is that there is a mechanism that can manufacture perceived consensus in our society, even when nothing near a consensus actually exists. It exposed that as human beings, many of us are susceptible to being influenced by that perceived consensus, journalists, scientists, government leaders, bureaucrats, and lay people alike.
We’re susceptible to this “megaphone,” as I like to call it.
The megaphone can influence us to dislike Trump, or dislike him more, or to dislike the person the powers that be anoint as the next Trump. It can influence us to be suspicious of, and even to demonize so-called “fringe epidemiologists” or “the unvaccinated.” It generates in us emotions that become deeply entrenched.
So what can we do?
We can set up and support parallel, truth-seeking organizations like The Chicago Thinker and The Epoch Times, like Hillsdale’s Academy for Science and Freedom that Drs. Arnn, Atlas, Bhattacharya & Kulldorff started to foster truth seeking in science (amazing that I have to say that!), like the Academic Sanity Consortium that is organizing this event.
But I would argue that it’s the censorship regime that has emerged as of 2017 that has particularly supercharged the megaphone.
The only immediate path is the legal path. Now is the time to set clear boundaries in stone, preferably by the Supreme Court.
That is why the case brought against the government by Missouri and Louisiana is so important. The case seeks a declaration that the government cannot get involved in policing speech. The declaration would block all federal government officials from collaborating, coercing, and colluding with media or social media companies to interfere with First Amendment rights.
Although Missouri and Louisiana have won a string of victories, the case will likely end up in the Supreme Court—which we should welcome.
A strong declaration from the Supreme Court that these public-private censorship efforts we saw during COVID are unlawful is probably the best insurance we can hope for right now to prevent future abuses
https://www.theepochtimes.com/the-clash-of-truth-and-power-exposing-the-underbelly-of-covid-19-censorship_5310698.html ?
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12 June, 2023
Mark Zuckerberg admits the establishment censored coronavirus skepticism that ended up being true or debatable: 'It really undermines trust'
Mark Zuckerberg said that the establishment was wrong to censor skepticism during the coronavirus pandemic that ended up being either true or debatable.
Zuckerberg, who is the CEO of Meta, the parent company of Facebook and Instagram, made the comments during an interview on the "Lex Fridman Podcast" while explaining the difficulties of identifying misinformation on social media.
"So misinformation, I think, has been a really tricky one because there are things that are obviously false, right, or they may be factual but may not be harmful. So are you gonna censor someone for just being wrong? If there's no kind of harm implication of what they're doing? There's a bunch of real issues and challenges there," said Zuckerberg.
"Just take some of the stuff around COVID earlier in the pandemic where there were real health implications, but there hadn't been time to fully vet a bunch of the scientific assumptions," he continued.
They don’t want you to see this … Big Tech does its best to limit what news you see. Make sure you see our stories daily — directly to your inbox.
"Unfortunately, I think a lot of the kind of establishment on that kind of waffled on a bunch of facts and asked for a bunch of things to be censored that, in retrospect, ended up being more debatable or true. And that stuff is really tough, right?" he added.
"It really undermines trust," Zuckerberg concluded.
Zuckerberg has been criticized by many on the right, most notably for censoring the Hunter Biden laptop story just ahead of the 2020 presidential election.
In an interview with Joe Rogan in August, Zuckerberg said that Facebook censored the story on the basis that the FBI had previously warned about the possibility of Russian disinformation being released in order to damage the Biden presidential campaign.
"We just kind of thought, hey look, if the FBI, which I still view is a legitimate institution in this country, it's a very professional law enforcement, they come to us and tell us that we need to be on guard about something, then I want to take that seriously," he explained at the time.
Zuckerberg said that they restricted the reach of the story after believing it fit the guidelines of Russian disinformation issued by the FBI. He said he didn't remember whether the FBI specifically singled out the Hunter Biden laptop story as disinformation.
https://www.theblaze.com/news/zuckerberg-misinformation-covid-censor
***********************************************Can Fluvoxamine Help Mitigate Some of the Problems with Long COVID? Dr. Eric Lenze is on a Mission
TrialSite has extensively chronicled fluvoxamine research during the COVID-19 pandemic, including the effort while Dr. David Boulware submitted an emergency use authorization (EUA) request to the Food and Drug Administration (FDA), but unfortunately, the agency rejected the initiative.
Involved early on with the research, Dr. Eric Lenze is at it again. The Washington University School of Medicine St. Louis investigator serves as Principal Investigator of the clinical trial titled “Fluvoxamine as a Treatment for Long COVID-19: A Randomized Placebo-Controlled Trial.”
The study tests the effects of fluvoxamine as a treatment for Long COVID. It’s estimated that anywhere between 10%-30% of persons infected with COVID-19 may be afflicted with the condition. According to some surveys, 14+ million people in the U.S. may struggle with some form of the condition. The investigator-initiated study is made possible by Washington University School of Medicine and a fund for COVID-19 studies called Balvi.
The study drug
An FDA-approved SSRI for Obsessive Compulsive Disorder (OCD), it’s been demonstrated in previous research that it can help prevent hospitalization in patients with COVID-19 (STOP COVID and TOGETHER trials). TrialSite reminds that tech entrepreneur Steve Kirsch put $1 million of his own money into the COVID-19 Early Treatment Fund (CETF) which helps early on investigate the SSRI drug’s efficacy against COVID-19. An early contributor to TrialSite via opinion editorials, Kirsch has become an intense anti-vax activist which was covered by MIT Technology Review.
This trial is testing whether fluvoxamine helps to improve symptoms and the negative impacts of long COVID. Importantly, Dr. Lenze, previously interviewed by TrialSite on the topic of fluvoxamine, leads this study. He has emerged as a leading key opinion leader on the topic of SSRI and SARS-CoV-2.
The study
Targeting 300 long COVID patients, the study investigates the use of fluvoxamine, an economical repurposed, FDA approved drug, as a promising drug for treatment of long COVID.
As far as study participants, they 1) are post-COVID-19 (at least 3 months since initial COVID symptoms and/or test confirming SARS-CoV-2 infection); and 2) have evidence of neurocognitive Long COVID (e.g., "brain fog", trouble concentrating, etc.) which is causing suffering and/or impairment.
Lenze and supporting staff seek in this study to determine whether fluvoxamine (1) reduces long COVID symptoms, 2) improves cognitive performance.
For the current study, Lenze and team at Washington University School of Medicine St. Louis will randomize participants to fluvoxamine, which is initially dosed at their preference, vs. placebo.
In the study, first, each participant will receive an acute dose of fluvoxamine: one dose of 25mg, then one dose of 50mg, then one dose of 100mg. Lenze and team will assess their subjective reaction to these test doses and use the information to randomize them to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
The investigators at this prestigious trial site communicate that the benefits of their study methodology include (1) participants are more likely to accept randomization and continue in the study if randomized to a dose they've already tested and accepted; (2) participants' initial response, if any, to the acute dose may allow future precision-medicine use of fluvoxamine, allowing physicians to give patients a test dose and then a full trial preferentially to participants who are likely to respond.
After the randomized portion of the trial, participants will be given an opportunity to participate in open-label treatment with fluvoxamine for 16 weeks. At the end of treatment, the study medication will be tapered off over an approximate 1–2-week period, depending on the final dose of study medication, and adjusted as appropriate if they experience discontinuation symptoms. Outcome assessments will be a combination of patient-reported assessments, validated neuropsychological tests, and biomarkers of underlying inflammatory pathophysiology.
The study’s primary outcome measure? Number of participants with improvement of long COVID symptoms over an 18-week duration.
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SARS-CoV-2 Mutations Evade manufactured antibodies
Not much use against Omicron
A prestigious team of UK-based scientists at University of Oxford, and the UK Health Security Agency investigate dynamics associated with monoclonal antibodies (mAbs) and SARS-CoV-2, the virus behind COVID-19. mAbs such as casirivimab+imdevimab were administered in combinations to minimize virus escape from neutralization, while other mAbs such as sotrovimab targeted specified conserved regions.
Now according to the Oxford-based scientists unprecedented genomic surveillance of SARS-CoV-2 in England has led to a “genome-first approach to detect emerging drug resistance in Delta and Omicron cases treated with casirivimab+imdevimab and sotrovimab respectively.” The scientists demonstrate using surface plasmon resonance and pseudoviral neutralization assays how SARS-CoV-2 mutations reduce or do away with mAb Aantibody affinity and neutralizing activity.
In this study, the investigators describe how the mutations occur within the antibody epitopes and for the Regeneron-developed casirivimab+imdevimab multiple mutations are identified, simultaneously impacting both components. They also demonstrate how, especially with Omicron, the pathogen evades Sotrovimab.
The study shows how the pathogen evades the neutralizing impacts of both classes of mAb. With Omicron mutation, Sotrovimab demonstrated an approximately sixfold reduction in neutralization.
The team’s experiment employs both plasmon resonance, an optical technique used to measure molecular interactions in real time, and pseudoviral neutralization assays to demonstrate in the lab how the mutations lessen, or completely render the mAbs not useful. The British-based scientists declare that this process is likely driven by immune evasion. Additionally, they showcase selected mutations and their lessening of associated neutralizing activity of COVID-19 mRNA vaccine-induced serum.
https://www.trialsitenews.com/a/sars-cov-2-mutations-evade-mabs-sterilizing-impact-b03340f0
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British cardiologist calls for mRNA vaccines to be suspended due to heart risks
A British cardiologist has called for Covid vaccines to be suspended in Australia due to heart risks, accusing the TGA of a “cover-up”.
A controversial British cardiologist has called for the Pfizer and Moderna Covid shots to be suspended in Australia until the risk of heart complications is better understood, saying prior vaccines “have been pulled for much less”.
Dr Aseem Malhotra, who has emerged as one of the most high-profile figures in the anti-vaccine movement and is currently in Australia on a speaking tour, said it was a “no-brainer” and accused the medicines regulator, the Therapeutic Goods Administration (TGA), of ignoring the clear safety signal from its own reporting system once the rollout was well under way.
“People can be forgiving if new information comes in, we know people make mistakes — but once you get that information back, them not acting on it … the problem is the cover-up is worse than the crime,” he said.
The 45-year-old boasts an impressive resume but has become a polarising figure since last year, when he first called for the suspension of mRNA Covid vaccines and started making claims — which have been disputed by fact checkers — about their dangers.
Professor Marc Dweck, chair of clinical cardiology at the University of Edinburgh, told The Guardian in January that Dr Malhotra’s opinions were “misguided and in fact dangerous”.
“The vast majority of cardiologists do not agree with his views and they are not based upon robust science,” he said. “I would strongly urge patients to disregard his comments, which seem to be more concerned with furthering his profile … rather than the wellbeing of the public.”
Dr Malhotra, a National Health Service-trained consultant cardiologist and prominent public health commentator for many years in the UK — particularly on diet-related illnesses and the pharmaceutical industry — appeared on breakfast TV in 2021 to encourage Britons to get vaccinated.
But last July, his father, Dr Kailash Chand, former deputy chair of the British Medical Association (BMA) died unexpectedly of a cardiac arrest at 73.
“At the time people were trolling me, saying it was the vaccine, and I got really angry and blocked them, because that was not my mindset — but then I started to notice increased incidences in cardiac deaths and I started to wonder,” he told The Telegraph earlier this year.
He would come to attribute the death of his father, who he described as “one of the fittest guys I knew”, to the Covid booster shot six months earlier.
“Previous scans showed he had nothing significant, no underlying conditions,” he said.
Dr Malhotra has since courted controversy with inflammatory statements on social media linking high-profile deaths or injuries to the vaccine, such as the on-field cardiac arrest of American football player Damar Hamlin in January.
In April, Hamlin told reporters that “the diagnosis of what happened to me was commotio cordis”, or a “direct blow at a specific point in your heartbeat that causes cardiac arrest”.
Dr Malhotra has also linked unusually high excess death rates in many developed countries to the vaccination rollout.
That claim has been widely disputed by experts, who instead attribute the rise in deaths to factors including Covid itself, undiagnosed illnesses after lockdowns, and strain on health services.
In January, the BBC was forced to apologise after Dr Malhotra “hijacked” a live TV interview to claim that “Covid mRNA vaccines do carry a cardiovascular risk” and call for the rollout to be suspended pending an inquiry into excess deaths.
But Dr Malhotra is unrepentant.
“Basically, all patients with unexpected heart attacks or cardiac arrests have to be seen as being caused by the vaccine until proven otherwise — even several months later, so even, I would say, up to two years since having the vax,” he said.
“As a cardiologist, it is unusual to see sudden cardiac death. We have a mechanism of action, it would be unscientific not to include it as a potential cause. What the vaccine does is it accelerates the progress of coronary artery disease, so someone who otherwise wouldn’t have is going to present several months or a year later.”
In recent months Dr Malhotra has been on a “world tour of activism”, even making an appearance on The Joe Rogan Experience in April.
The description for his Australian tour says he will be “raising public awareness about vaccine injuries and providing a risk-benefit, evidence-based analysis of the Covid vaccines with special emphasis on cardiovascular complications and solutions”.
Despite speaking at a series of sold-out events in Sydney, Melbourne, Canberra, Adelaide, Perth and the Gold Coast, Dr Malhotra’s Australian tour has been met with a virtual media blackout.
Save for an appearance on Sky News Australia and an article in the small local publication Canberra Weekly about his speech there, most media outlets have steered well clear.
Dr Malhotra said it only highlighted the disconnect between the public and institutions including government, health and media.
“What’s really interesting is everyone comes up to me and is aware, and doctors are seeing stuff, but they are generally afraid to say anything,” he said, adding he was meeting many doctors at his talks.
“You could argue I’m speaking to an echo chamber … [but] the professionals are very supportive — they’re horrified, sad. When you speak to people on the ground, taxi drivers, shopkeepers, everyone is aware of someone they know, either a family member or friend, who suffered a serious adverse event.”
Dr Malhotra said the “objective evidence to support the fact there is a disconnect between the public and the establishment is people are not turning up” to get boosters.
According to the most recent Health Department figures, 16.5 million Australians, or 82 per cent, had their last Covid vaccine more than six months ago, making them “out of date” under the new definition.
Just under 3.1 million, or 15 per cent, have had a vaccine within the last six months.
“There is a massive drop among people who are recommended to have boosters,” he said. “That [loss of trust] is not a good recipe — where does that lead us next?”
Myocarditis and pericarditis — inflammation of the heart or lining around the heart — are known but rare side effects of the mRNA vaccines.
According to the TGA, myocarditis is reported in one to two out of every 100,000 people who receive Pfizer or Moderna, but young men and boys are more at risk.
“These are usually temporary conditions, with most people getting better within a few days,” the TGA says. “Vaccination against Covid-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination far outweigh the potential risks.”
As of May 28, 2023, the TGA has received 138,730 total adverse event reports from 67.4 million doses administered, a rate of 0.2 per cent.
The medicines regulator has identified 14 reports where the cause of death was linked to vaccination, from 986 reports received and reviewed.
But Dr Malhotra is one of a growing number of health professionals arguing the true rate of serious adverse events is far higher than reported.
He accused the TGA of “wilful blindness”.
“Think about it from a psychological perspective — they are responsible in a way for approving and the mandating of these vaccines for all Australian citizens — it’s not easy to suddenly acknowledge what they’ve done is harm people to such a significant degree,” he said.
“It’s much easier to bury your head in the sand. I would be mortified to know what I’d done, even accidentally. But having said that, it is their job — there has to be accountability.”
He stressed he was a supporter of vaccines, and that’s why “people have to believe in the safety of vaccines”.
“Historically, traditional vaccines have a serious adverse event rate of one in one million — other vaccines have been pulled for much less,” he said, citing the 1976 swine flu vaccine which carried a one in 100,000 risk of Guillain-Barré Syndrome, and the 1999 rotavirus vaccine which was linked to bowel obstruction at a rate of one in 10,000.
In December, former AMA president Dr Kerryn Phelps broke her silence about the “devastating” vaccine injury she and her wife suffered after Pfizer.
In a bombshell submission to parliament’s Long Covid inquiry, the former federal MP revealed she had spoken with other doctors “who have themselves experienced a serious and persistent adverse event” but that “vaccine injury is a subject that few in the medical profession have wanted to talk about”.
“Regulators of the medical profession have censored public discussion about adverse events following immunisation, with threats to doctors not to make any public statements about anything that ‘might undermine the government’s vaccine rollout’ or risk suspension or loss of their registration,” she said.
Last week, Dr Phelps lent her tacit support to Dr Malhotra’s visit, sharing the Canberra Weekly article on social media in which he called for an inquiry into mRNA vaccines.
She declined to comment, however, saying she had not attended his talk in person.
Another high-profile physician, 2020 Australian of the Year Dr James Muecke, attended Dr Malhotra’s Adelaide talk over the weekend, happily posing for a photo afterwards.
But Dr Malhotra said there was a “culture of fear” with some people reluctant to even be seen attending his talks.
“All of this is suppression of free speech — Australians need to know their democracy is under attack,” he said.
The speaking tour is being arranged by the Australian Medical Professionals’ Society (AMPS) — one of several splinter organisations born out of opposition to Covid vaccine mandates in 2021 — and sponsored by Gold Coast-based internet radio station TNT Radio, which the website Crikey recently described as “a home for Australia’s fringe political figures and international conspiracy theorists”.
Australian Council of Trade Unions (ACTU) secretary Sally McManus in 2021 branded AMPS and other groups under the umbrella of Queensland-based Red Union as “fake unions run by LNP members and their associates set up to try and divide working people”.
Dr Malhotra countered that the smearing of anyone raising concerns as anti-vaxxers, conspiracy theorists or “cookers” was “part of the playbook” of the drug industry.
“One of the ways is through opposition fragmentation — it involves smearing and deplatforming those who are countering their narrative,” he said.
“This is not unusual. This is deliberate. If there are people who are in opposition, this is how we discredit them, this is how we frame them to other people in society. Big tobacco did it for many years — this is not new.”
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8 June, 2023
Risk Factors Associated With Post?COVID-19 Condition
A Systematic Review and Meta-analysis
TINY benefit from vaccination -- OR 0.57. Long Covid was
basically just as common in vaccinated and unvaccinated people
Vasiliki Tsampasian et al.
Question Which individuals are at risk of developing post?COVID-19 condition (PCC)?
Findings This systematic review and meta-analysis of 41 studies including 860 783 patients found that female sex, older age, higher body mass index, smoking, preexisting comorbidities, and previous hospitalization or ICU admission were risk factors significantly associated with developing PCC, and that SARS-CoV-2 vaccination with 2 doses was associated with lower risk of PCC.
Meanings The findings of this systematic review and meta-analysis provide a profile of the characteristics associated with increased risk of developing PCC and suggest that vaccination may be protective against PCC.
Abstract
Importance Post?COVID-19 condition (PCC) is a complex heterogeneous disorder that has affected the lives of millions of people globally. Identification of potential risk factors to better understand who is at risk of developing PCC is important because it would allow for early and appropriate clinical support.
Objective To evaluate the demographic characteristics and comorbidities that have been found to be associated with an increased risk of developing PCC.
Data sources Medline and Embase databases were systematically searched from inception to December 5, 2022.
Study Selection The meta-analysis included all published studies that investigated the risk factors and/or predictors of PCC in adult (?18 years) patients.
Data Extraction and Synthesis Odds ratios (ORs) for each risk factor were pooled from the selected studies. For each potential risk factor, the random-effects model was used to compare the risk of developing PCC between individuals with and without the risk factor. Data analyses were performed from December 5, 2022, to February 10, 2023.
Main Outcomes and Measures The risk factors for PCC included patient age; sex; body mass index, calculated as weight in kilograms divided by height in meters squared; smoking status; comorbidities, including anxiety and/or depression, asthma, chronic kidney disease, chronic obstructive pulmonary disease, diabetes, immunosuppression, and ischemic heart disease; previous hospitalization or ICU (intensive care unit) admission with COVID-19; and previous vaccination against COVID-19.
Results The initial search yielded 5334 records of which 255 articles underwent full-text evaluation, which identified 41 articles and a total of 860 783 patients that were included. The findings of the meta-analysis showed that female sex (OR, 1.56; 95% CI, 1.41-1.73), age (OR, 1.21; 95% CI, 1.11-1.33), high BMI (OR, 1.15; 95% CI, 1.08-1.23), and smoking (OR, 1.10; 95% CI, 1.07-1.13) were associated with an increased risk of developing PCC. In addition, the presence of comorbidities and previous hospitalization or ICU admission were found to be associated with high risk of PCC (OR, 2.48; 95% CI, 1.97-3.13 and OR, 2.37; 95% CI, 2.18-2.56, respectively). Patients who had been vaccinated against COVID-19 with 2 doses had a significantly lower risk of developing PCC compared with patients who were not vaccinated (OR, 0.57; 95% CI, 0.43-0.76).
Conclusions and Relevance This systematic review and meta-analysis demonstrated that certain demographic characteristics (eg, age and sex), comorbidities, and severe COVID-19 were associated with an increased risk of PCC, whereas vaccination had a protective role against developing PCC sequelae. These findings may enable a better understanding of who may develop PCC and provide additional evidence for the benefits of vaccination.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2802877
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Some Sudden Deaths Caused by COVID-19 Vaccines, Autopsies Confirm
Some sudden deaths were caused by COVID-19 vaccines, autopsies have confirmed.
Eight people who died suddenly after receiving a messenger RNA (mRNA) COVID-19 vaccine died due to a type of vaccine-induced heart inflammation called myocarditis, South Korean authorities said after reviewing the autopsies.
“Vaccine-related myocarditis was the only possible cause of death,” Dr. Kye Hun Kim of the Chonnam National University Hospital and other South Korean researchers said.
All of the sudden cardiac deaths (SCD) occurred in people aged 45 or younger, including a 33-year-old man who died just one day after receiving a second dose of Moderna’s vaccine and a 30-year-old woman who died three days after receiving a first dose of Pfizer’s shot.
Myocarditis wasn’t suspected as a clinical diagnosis or cause of death before the autopsies, researchers said.
Thirteen other deaths were recorded among those who experienced myocarditis after COVID-19 vaccination but no autopsy results were detailed. Some of those who died had received AstraZeneca’s COVID-19 vaccine.
The results show the need for “careful monitoring or warning of SCD as a potentially fatal complication of COVID-19 vaccination, especially in individuals who are ages under 45 years with mRNA vaccination,” according to the researchers, who reported the findings in a study published by the European Heart Journal on June 2.
The study was funded by the South Korean government.
Dr. Andrew Bostom, a retired professor of medicine in the United States who wasn’t involved in the research, said the results emphasize why mandating and promoting vaccines for younger people was wrong.
“These are people who ostensibly did not need the vaccine,” Bostom told The Epoch Times after reviewing the paper. “That’s what adds insult to injury.”
The overall occurrence of myocarditis after COVID-19 vaccination was rare, according to the study, though one of its limitations is that the true number could be higher.
Out of 44.2 million people who received at least one dose of the Pfizer, Moderna, Johnson & Johnson, or AstraZeneca vaccines between Feb. 26, 2021, to Dec. 31, 2021, 1,533 cases of suspected myocarditis were reported to the Korea Disease Control and Prevention Agency. Out of those, an expert adjudication committee confirmed 480 cases of vaccine-induced myocarditis.
The cases primarily happened in males and people under 40. All but 18 were caused by an mRNA vaccine.
The overall rate was one case per 100,000 vaccinated persons. The highest rates were in 12- to 17-year-olds, with 3.7 cases per 100,000 and 5.2 cases per 100,000 males.
The numbers weren’t broken down by vaccine type and age, meaning the rates were diluted because they included non-mRNA vaccine recipients. Excluding non-mRNA shots has led to the estimation of higher rates in other places, such as 75.9 cases per one million second Pfizer doses in 16- and 17-year-old American males.
Both those numbers and the Korean figures are prone to underreporting. In Korea, authorities automatically excluded any cases involving myocarditis developed 43 days or more after vaccination as well as any cases that included a positive COVID-19 test, despite some experts asserting there’s stronger evidence for vaccine-caused myocarditis than COVID-19-induced heart inflammation.
“We have kids showing up, young adults showing up with chest pain, and most of them end up in the hospital for 24, 48, 72 hours and they go home. But are we missing people that are dying before they get to the hospital?” Dr. Anish Koka, an American cardiologist, told The Epoch Times after reviewing the study.
“Now, just because we live in the real world and we’re not seeing avalanches of kids dying, we know that it’s a rare signal, but how rare is it? Is it happening?” he added. “The new study clearly shows that it’s happening. No doubt we’ve had deaths happen in the U.S. post-vaccine that have just not been attributed correctly.”
Myocarditis is a known side effect of the mRNA COVID-19 vaccines and can cause death, according to previous research and medical examiners. Symptoms included chest pain, trouble sleeping, and fever. While many people who experience myocarditis after vaccination are discharged from the hospital within a day or two, they can still suffer from long-term problems.
The new study classified 1 in 5 vaccine-induced myocarditis cases as severe. Those cases involved one or more of the following: intensive care unit admission, fulminant myocarditis, usage of extracorporeal membrane oxygenation, heart transplantation, and death.
“A fifth of the cases were determined to be serious,” Bostom said. “It’s disturbing.”
Reporting System
South Korea’s government established a reporting system for all adverse events following vaccination before COVID-19 vaccines were rolled out, tying it to a national compensation system that pays for medical expenses related to the adverse events.
The system even provides compensation to people who cannot establish causality to a vaccine but provide evidence such as temporal association, or the event happening soon after vaccination. Authorities also grant money to people who suffer mild effects.
More than 20,000 people were compensated through the program as of August 2022.
In contrast, the system in the United States has compensated just four people as of May 1, and rejected a number whose doctors diagnosed them with vaccine injuries.
Both countries require health care workers to report certain events after vaccination, such as myocarditis, though not all cases have been reported, at least in the United States.
U.S. officials have reviewed autopsies done on people who died after receiving COVID-19 vaccines but have refused to release them. In an update in February, officials said they would provide some information from the autopsy reports but to date have not done so.
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7 June, 2023
Why do, even now, so few accept that lockdown was like burning down your home to destroy a wasp's nest?
By PETER HITCHENS
We will never know exactly how foolish it was to close down the country in the spring of 2020.
It is beginning to dawn on some people that it might actually have been an error. But will it ever be broadly agreed that it was so?
A report published yesterday — hundreds of pages of devastating detail from experts at Johns Hopkins University in the U.S. and Lund University in Sweden — concluded the supposed benefits of lockdown were 'a drop in the bucket' when compared to the costs. Or, as I would put it, they were like burning down your house to get rid of a wasps' nest.
This report (in fact a revised version of an earlier document first issued in May 2022) will shock many Lockdown enthusiasts by saying that closing the country saved as few as 1,700 lives in England and Wales in spring 2020.
It ought to weigh heavily on the anti-panic side of the scales. I hope it will. But will it resolve anything? I have my doubts.
I still meet plenty of people who insist that our only national mistake was not to lock down harder and sooner than we did. This is why I am quite sure many of those who supported these moves will never abandon their position.
Those of us who, like me, took the other view, are unlikely to shift either. Why is this?
I have come to the conclusion that it is really about whether people like being bossed about for their own good, or whether they do not. A surprising number of us turn out to love Big Brother. Not only could these illiberal types not get enough of doom-packed propaganda, decrees urging them to stay at home, keep their distance and wear masks, but they were sorry when it ended.
Those who think that statistics and reason will resolve this are likely to be disappointed.
Here are some riddles that I doubt will ever be solved. What did we mean by a 'Covid death'? Someone who died solely of Covid, somebody who died partly of something else but had Covid at the time, or someone who died almost wholly of something else but had Covid at the time?
I do not think it was ever clear then and so it cannot be clear now. Then there is the cost. Is there any accurate, precise way of counting how many cancer patients died because Covid restrictions postponed urgent treatment?
How will we ever measure precisely how many people had their schooling or university courses wrecked?
Will the price of closing the economy, in inflation, taxes, destroyed businesses and lost jobs, ever be computed?
And what about the old people whose health was damaged by being forced to stay at home and abandon their active existences?
You might as well try to weigh a thunderstorm.
The facts are incredibly difficult to set out precisely and always will be. Behind them all lies an unverifiable claim that doing little or nothing would have killed thousands more.
I would say the example of Sweden shows this is not true. Sweden got by well without closing down. But they will be met by others who say its more restrictive Nordic neighbours did better, and it was saved by its position far from the main travel routes of the world.
Even what seems to me to be clear evidence that masks were futile is disputed by others who insist they were effective. So those who wish to believe this was a good idea are difficult to persuade otherwise.
While I have my own opinions, and am very glad I expressed them, my heart sinks at the prospect of years of reports and counter-reports. Everything in this debate moves just out of our reach, like a mirage, as you try to grab it.
Though my own view is pretty much the same as that of the report, will it persuade you? And will Lady Hallett's official Covid Inquiry solve the problem? I rather doubt it.
There is one good thing, which yesterday's document confirms. Debate was justified.
It was reasonable for me to raise objections at the time. It is increasingly respectable to suspect something went badly wrong, that at least we might have gone too far, that smart scientific and medical voices such as Sunetra Gupta and Carl Heneghan were justified and responsible when they raised doubts; and that Jonathan Sumption, the retired Supreme Court judge, was also acting responsibly when he protested against the suppression of liberty by ill-made and excessive laws.
After all, common sense should have warned us that the spring 2020 restrictions were an astonishing departure from normal practice.
An average of about 11,000 people a week die in England and Wales in normal circumstances. I remember producing such figures on the average deaths per week or per day to try to calm things down as the shutdown frenzy gathered pace.
People die all the time. It is very sad, and often avoidable, but it was not — at the scale we were experiencing — a reason to close society and the economy.
It was fascinating how little effect it had. Almost everyone I knew actively preferred to be terrified, as if they longed for Big Brother to enfold them in his strong and loving arms.
Terrifying accounts of overloaded Covid wards circulated. And then there were the TV reports from northern Italy. I would love to see those reports calmly re-analysed now. But the impression they gave was, on the face of it, horrifying. Pictures of great piles of coffins — something everyone involved would once have striven to keep off the air because it was so macabre — probably clinched it.
Lockdown's godfather, British epidemiologist Professor Neil Ferguson, has since explained how the spectacle of a health crisis in Italy persuaded British authorities to follow the Chinese model instead. He described how Sage, the Government's scientific advisory group, had watched as China's despots embarked on an unheard-of form of disease control by shutting down an entire province.
'They claimed to have flattened the curve. I was sceptical at first. I thought it was a massive cover-up by the Chinese. But as the data accrued it became clear it was an effective policy.
'Then, as infections seeded across the world, springing up like angry boils on the map, Sage debated whether, nevertheless, it would be effective here. 'It's a Communist one-party state,' we said. 'We couldn't get away with it in Europe,' we thought. In February one of those boils raged just below the Alps.
'And then Italy did it. And we realised we could.'
What he meant by 'get away with it', I am not quite sure.
'Effective' still seems to me to be an unjustified claim. Why would anyone see such things in these terms? But an internal Government document from around the same time spoke openly of fanning fear, advising officials: 'A substantial number of people still do not feel sufficiently personally threatened . . . The perceived level of personal threat needs to be increased among those who are complacent, using hard-hitting emotional messaging.'
In my view it was this, the acceptance of Chinese totalitarian methods as normal, the use of fear to isolate and crush opposition, that were plainly wrong and should never ever be allowed to happen again.
There should have been free, two-sided debate. Whatever you think about the effectiveness of lockdowns, we must not allow ourselves to be frightened into the strong arms of Big Brother. Next time, he may be more reluctant to let us go free again.
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COVID-19 Vaccine Effectiveness Degrades to 9% After Nine Months
Researchers affiliated with Northern Italian academic medical centers in Tento and Milan analyzed 40 studies in a systematic meta-analysis chronicling vaccination status and subsequent COVID-19 infection confirmed by standard testing. Covering periods during circulation of both the Delta and Omicron variants, the study was published in the peer-reviewed journal JAMA Network Open.
On average vaccine effectiveness after 30 days was 53%.when it comes to protection against symptomatic COVID-19. This was regardless of COVID-19 vaccine, whether the mRNA vaccines (Pfizer-BioNTech, Moderna) or other COVID-19 jabs from AstraZeneca or Sinovac. The researchers represented by corresponding author Piero Poletti, PhD, Bruno Kessler Foundation reports that the investigators did detect variances among different vaccines. For example, on the higher end of performance, Moderna’s mRNA jab averaged 62% effective against symptomatic disease 30 days after vaccination; that performance waned considerably when looking at the Sinovac vaccine performance (32%) after 30 days.
After six months vaccine performance is abhorrent, equaling 14% on average for all the vaccines, dropping further to 9% after nine months. Not surprisingly, the durability of the vaccines worsened during the Omicron stage versus the time when Delta was predominantly in circulation. While as with other studies, this meta-analysis revealed that administration of a booster dose of COVID-19 vaccine surge protection again to primary vaccination levels (60% at 30 days), unfortunately, and not surprisingly, this protection degraded rapidly (13% at nine months).
This study included numerous limitations. For example, the study team didn’t look into levels of protection associated with severe disease, hospitalization and death associated with COVID-19. TrialSite has reviewed numerous studies and the COVID-19 vaccines tend to perform somewhat better for longer periods of time against more serious, severe cases, but their performance does wane as well.
Limitations
The authors report that vaccine effectiveness differences across age groups were only partially assessed. Original vaccine effectiveness estimates against Omicron symptomatic disease and laboratory-confirmed infection associated to sublineages BA.1 and BA.2. Although a similar waning of vaccine immunity was found between these 2 sublineages, uncertainty remains on the effect of booster doses against more recent sublineages and the temporal patterns of VE associated with bivalent vaccines. The authors report that estimates of vaccine effectiveness against laboratory-confirmed infection must be cautiously interpreted. Several other limitations are delineated.
Summary
The Italian led team evaluated the duration of vaccine-induced protection against symptomatic and laboratory-confirmed infection against the Delta and Omicron variants. The authors report:
“The estimates provided in this study can be instrumental to evaluate the susceptibility profile of populations with different levels of vaccinations, uptake by age, and vaccine products. This work could foster discussion on appropriate targets and timing for future vaccination programs.”
Importantly all of the COVID-19 vaccines waned in effectiveness, evidencing “a marked immune escape is associated with Omicron infection and symptomatic disease, with similar waning rates after the primary vaccination cycle and the booster dose.”
While a booster dose can be immune-inducing, and thus a “restoration of the vaccine protection against symptomatic disease to levels comparable to those estimated soon after completion of the primary cycle” these rates decline fast as well. Although primary series and boosters based on other studies do offer a more robust durability against severe disease, hospitalization and death. But it’s not quantifiably clear how robust this protection is either.
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6 June, 2023
Vaccine Critic Banned by Major Social Media Site, Campaign Pages Blocked
Twitter owner Elon Musk invited Democrat presidential candidate Robert F. Kennedy Jr. for a discussion on his Twitter Spaces after Kennedy said his campaign was suspended by Meta-owned Instagram.
“Interesting… when we use our TeamKennedy email address to set up @instagram accounts we get an automatic 180-day ban. Can anyone guess why that’s happening?” he wrote on Twitter. An accompanying image shows that Instagram said it “suspended” his “Team Kennedy” account and that there “are 180 days remaining to disagree” with the company’s decision.
In response to his post, Musk wrote: “Would you like to do a Spaces discussion with me next week?” Kennedy agreed, saying he would do it Monday at 2 p.m. ET.
Hours later, Kennedy wrote that Instagram “still hasn’t reinstated my account, which was banned years ago with more than 900k followers.” He argued that “to silence a major political candidate is profoundly undemocratic.”
“Social media is the modern equivalent of the town square,” the candidate, who is the nephew of former President John F. Kennedy, wrote. “How can democracy function if only some candidates have access to it?”
It’s not the first time that either Facebook or Instagram has taken action against Kennedy. In 2021, Instagram banned him from posting claims about vaccine safety and COVID-19.
After he was banned by the platform, Kennedy said that his Instagram posts raised legitimate concerns about vaccines and were backed by research. His account was banned just days after Facebook and Instagram announced they would block the spread of what they described as misinformation about vaccines, including research saying the shots cause autism, are dangerous, or are ineffective.
“This kind of censorship is counterproductive if our objective is a safe and effective vaccine supply,” he said at the time.
Kennedy, the son of former presidential candidate and Sen. Robert Kennedy, has for years helped to popularize the assertion that vaccines are liked to autism. Kennedy’s Children’s Health Defense, before it was also banned on Facebook and Instagram in 2022, claimed that tetanus vaccines can cause infertility and that polio vaccines are actually responsible for a rise in polio cases worldwide.
However, critics of Big Tech monopolies have said social media companies should not be the arbiters of what can and cannot be posted, saying that some content moderation policies around “misinformation” is tantamount to censorship.
That criticism reached a boiling point in early 2021 after former President Donald Trump was banned on Twitter, Facebook, YouTube, and other Big Tech sites before his accounts were mostly reinstated. A number of other prominent conservatives and individuals who questioned mainstream narratives were also banned in 2021 and 2022.
Because of the widespread bans that were handed down, some alternative social media websites like Trump’s Truth Social, video platform Rumble, Gettr, and others were created. When Musk bought Twitter late last year, he moved to reinstate a number of prominent conservative accounts, including Trump’s page, although the former president hasn’t yet used it and currently posts on Truth Social.
Censored for ’18 Years’
During his 2024 presidential announcement, Kennedy said that he’s been censored “for 18 years,” likely due to his claims about vaccines. “They shouldn’t have shut me up that long,” he said, adding that he’s “really” going to “let loose on them for the next 18 months.”
In an interview with CNN days later, Kennedy was asked about who censored him and why. He responded by saying that at least a dozen Democrat attorney generals recently had contacted social media sites to “censor me” and said that there is now “clear evidence” via the Twitter Files reporting that White House officials colluded with Big Tech to suppress his accounts.
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Low COVID-19 Pediatric Vax Rates: Parents Concerned about Long-Term Effects of mRNA Vaccines & Responsibility
A recent study conducted by the Center for Economic and Social Research (CESR) at the University of Southern California (USC) Dornsife College of Letters, Arts and Sciences investigates why COVID-19 rates among children are so low. The study led by research scientist Ying Liu and colleagues finds that parents worry about long-term risks associated with the COVID-19 vaccines, not to mention the responsibility of being at fault should their children become ill after the inoculation procedure.
Recently published in Pediatrics, the USC Dornsife team surveyed parents in the Understanding America Study during the Omicron variant’s surge between February and March 2022, when pediatric COVID-19 cases peaked. The Southern California-led team covers the topic of lower COVID-19 vaccine rates across the pediatric population.
For example, while 92% of adults have received COVID-19 vaccination, only 39% of children 5 to 11 and 68% of persons 12 to 17 are fully vaccinated.
The study results reveal that 45% of parents believed the vaccine’s long-term risks to their child outweighed the risks of not being vaccinated. 18% of the surveyed parents articulated that they would feel responsible if their child became sick post-vaccination.
According to study lead, Liu, “Parents’ hesitancy may be partly driven by apprehension about the vaccine, stemming from its rapid development and the use of newer techniques.”
"People often exhibit a more cautious approach when making medical decisions for others, including their own children, than for themselves,” Liu said. “Some tend to do nothing rather than vaccinate their child, even though such inaction could result in negative consequences.”
The study authors appear substantially focused on the driving goal of increasing the COVID-19 vaccination rate of young people, less a deeper look into parental concerns.
Parental concerns about the prospect of the COVID-19 vaccine's long-term effects aren’t irrational. The COVID-19 vaccines (the current commercial investigational products) have not been studied long-term. True, mRNA-based vaccines and therapies have been under investigation for a few decades, but actual commercial products are just a few years old. TrialSite has reported before on Moderna in its investor disclosure reports in 2019 and 2020, indicating the totally novel nature of the mRNA vaccine products.
In fact, the current bivalent COVID-19 vaccines now in circulation remain investigational and under emergency use authorization. The versions of the vaccine that were licensed/approved (monovalent primary series of both Pfizer-BioNtech and Moderna) have been scrapped by the Food and Drug Administration (FDA) in favor of the investigational bivalent products.
While some studies suggest the risks of myocarditis/pericarditis associated with mRNA-based COVID-19 vaccines are substantially less than the risk associated with COVID-19 itself, other studies reveal a disturbingly high incidence of cardiovascular-related adverse events associated with the vaccines.
The FDA has authorized the bivalent COVID-19 (original strain and BA.4/BA.5) vaccine now as the only product available for children aged 6 months and up. The overall vaccination rate associated with experimental (investigational) released in September 2022 hovers at about 20% for all eligible Americans. Clearly, some concerns accumulate across society about the COVID-19 vaccines.
Concerns about myocarditis for example should be discussed openly—not discounted while other COVID-19 pediatric risk-benefit factors such as state and severity of the virus, variant, infection rate and natural immunity from previous infection all need to be understood as part of an unfolding pediatric-based` risk-benefit analyses.
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The European left’s fascism fantasy
France, Sweden, Italy, Finland and now Spain. The demise of the left in western Europe continues apace and yet their only solution is to seethe about fascists in a make believe world of their own.
Nine months after Giorgia Meloni was elected Prime Minister – remember the hysterical warnings about her being Mussolini in heels – the only horror the Italian left has experienced is electoral wipeout. At last weekend’s local elections, Meloni’s conservative Brothers of Italy party romped to victory in many towns that were once staunchly Socialist. As a jubilant Meloni crowed: ‘Strongholds [of the left] no longer exist.’
Nine months after Giorgia Meloni was elected Prime Minister, the only horror the Italian left has experienced is electoral wipeout
At the same time Italians were endorsing Meloni, Spanish voters showed what they thought of the ruling Socialist Workers’ party in their local and religion elections. Not much. The big winners were the Popular party and Vox, prompting a rattled Prime Minister Pedro Sánchez to call a snap general election. According to El Pais his Socialist party needs ‘a miracle to halt the conservative wave that has already swept through several European countries’.
Vox have in the past been compared to the Nazi party, though these days the left sees Hitler and Mussolini on every street corner. Querying the wisdom of mass immigration is one short goosestep from fascism, as is sticking up for the traditional family structure or simply waving your country’s flag.
When Meloni was elected Prime Minister of Italy in September the news wasn’t well received by her French counterpart. One might have expected Elisabeth Borne – a Socialist by breeding before she jumped ship to Macron’s centrist party – to be the first on the phone to celebrate Girl Power. Instead Borne gave a masterclass in pomposity, declaring that Meloni better adhere to European ‘values’, or else.
Borne was on her high horse again on Sunday, using an interview to describe Marine Le Pen’s National Rally as the ‘heir to Pétain’, and warning against any ‘normalisation’ of the party.
Borne’s reference to Marshal Philippe Pétain’s wartime Vichy government has infuriated Le Pen’s party, and even irritated Emmanuel Macron. During a Council of Ministers on Tuesday the president upbraided his Prime Minister by stating that ‘you won’t be able to make millions of French people who voted for the far right believe that they are fascists.’
Such tactics might have worked in the 1990s, added the president, ‘but the fight against the far right no longer involves moral arguments.’
Macron is correct. Had Borne, the daughter of a holocaust survivor, made her comments three decades earlier she would have been on firmer ground. When Le Pen’s father, Jean-Marie, founded the National Front in 1972 it contained some very unpleasant individuals, including the vice-president, who served in the Milice, Vichy’s paramilitary wing, and the treasurer, who fought for the French Charlemagne Division in the Waffen SS.
Then again, the Socialist party of the 1970s also contained some dubious characters, such as its leader, Francois Mitterrand. He worked for the Vichy regime in the early years of the war and, during his 14 years as president, he steadfastly refused to apologise for the complicity of France in deporting 74,100 Jews to concentration camps. The Vichy police chief who organised the deportation, Rene Bousquet, was a friend of Mitterrand after the war.
The Vichy period was a complex one for the Republic. As Julian Jackson wrote in France: The Dark Years 1940-1944: ‘The collaborationist world was not homogeneous – it contained pacifists and fascists, Socialists and Catholics… collaborationist politics was a vipers’ nest of hatreds.’
More to the point, that period is in in the past and it is best left alone by 21st century politicians. The same is true in Italy; it’s the present that matters and Meloni’s popularity tells its own story.
So does Le Pen’s, whose party is widely acknowledged to have emerged from the pension reform saga in the best shape. Recent opinion polls indicate that she is enjoying unprecedented levels of approval among the electorate.
The National Rally are also benefiting from the rampant lawlessness engulfing France and the lack of any coherent government strategy to tackle the growing immigration crisis.
These issues explain the recent successes of socially conservative parties throughout most of continental Europe. In truth, however, their popularity has as much to do with voters’ rejection of radical progressivism, the aggressive and divisive dogma that has so intoxicated the left this century.
Politicians like Elisabeth Borne should stop wasting words demonising the opposition and focus their energy on how they can normalise the left.
Too many on the European left have turned their backs on their traditional bases. They have courted middle-class students and urban elites, pandering to their esoteric social justice obsessions while sneering at the working-class respect for faith, flag and family. Nor do they seem particularly bothered about the crises in health, education and social housing.
That is why Meloni is Prime Minister and Marine Le Pen’s National Rally have 88 MPs in the National Assembly; not because they are fascists but because they have replaced the left.
https://www.spectator.com.au/2023/06/the-european-lefts-fascism-fantasy/
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French Research Establishment Intensifies Attack Against Hydroxychloroquine Proponents during COVID-19
A controversial French physician-investigator and hydroxychloroquine proponent continues to find trouble, as it’s now reported in French media that top researchers in an op-ed in a popular media seek to punish Didier Raoult and colleagues given that they designed and conducted the large study investigating the use of hydroxychloroquine targeting COVID-19, what the opponents tout as being described as “the largest ‘unauthorized’ clinical trial ever seen.”
Why the ongoing, continued attacks, given French society has moved beyond the COVID-19 emergency? Just about nothing was more controversial than the use of repurposed drugs targeting COVID-19.
Of course, this news represents the continued controversy of the repurposed generic drug hydroxychloroquine as a possible treatment for COVID-19. Much of the medical establishment has written off this drug, yet the studies have trickled in suggesting some promise regardless of the naysayers. But whom to believe? This is the challenge.
The medical establishment, defined for purposes herein represents the leading opinions emanating from the predominant health care systems, hospitals and clinics, medical research universities and government health agencies from regulators to public health of a nation, region or even worldwide. In the intensive controversy and conflict over key topics during the COVID-19 pandemic, TrialSite observed that nothing can become more politicized than the topic of medicine and broader healthcare. It’s a $1+ trillion economy in America and a lot of smart people with a lot of evidence-backed options, at times on both sides of a polar oppositional equation. But the world can be a complex place, as can be science, and an open mind, with an objective stance is required, along with the wherewithal to continuously scan unfolding data from around the world.
Controversy & politicization
Perhaps, no drug was more politicized than hydroxychloroquine (of course unless its ivermectin), as early on in the pandemic as under the Trump presidency. The Food and Drug Administration in March 2020 reluctantly issued an emergency use authorization for the drug. This action was seen as the Trump administration trying to force a solution on the regulatory agencies, leading to mounting tension, and according to TrialSite accounts, outright information war between different factions of power. Ultimately, according to the National Institutes of Health (NIH), FDA and a majority consensus of the medical and research establishment, the drug was to be avoided for any use involving COVID-19. See the ongoing FDA recommendation to not prescribe the drug.
Similar tensions broke out in other countries, such as Brazil, where their conservative president Jair Bolsonaro also openly supported use of the drug in response to the pandemic. Along the way, strange and even shady situations emerged such as Surgisphere, a Chicago-based analytics company that came under scrutiny by May 2020. The company purportedly provided large datasets of COVID-19 patients, publishing the data in The Lancet and the New England Journal of Medicine by May 2020. TrialSite openly questioned the credibility of the studies based on the highly questionable access to pervasive health data around the world.
TrialSite engaged with the company to elicit questions while the prestigious journals that strangely published the Surgisphere material ultimately retracted those articles.
But why did such prestigious journals publish such questionable material so fast? Was it the urgency of the moment—those early days in the pandemic? Or were more nefarious elements involved? The data suggested a “significantly higher risk of death” associated with hydroxychloroquine. An anti-hydroxychloroquine fervor intensified and even the World Health Organization dropped its clinical trials testing the drug.
The NIH backed off on any positive finding, only to recommend the drug if for a clinical trial. Several studies showed promising results as reported in TrialSite, such as an observational study conducted at Henry Ford Health System.
The situation became so ridiculous in America that at one point during the pandemic if someone raised the topic of hydroxychloroquine, they were immediately labeled a right wing, Trump-loving, MAGA supporter, or loon from the mainstream. And dare to challenge its efficacy to the drug’s proponents, and you were a bought off shill for Big Pharma. The pandemic revealed the worst of our character.
On the one side was an all-encompassing, uniform response that the drug just didn’t work against SARS-CoV-2—ignoring any positive data that may have been generated; while a vocal minority, backed at first by Trump and MAGA, swore the drug could do miracles. Both sides were incorrect.
The French study
TrialSite reported on some of the research led by Dr. Raoult, who used to head the IHU Mediterranee research hospital, and his colleagues who were, especially before the introduction of the COVID vaccines, open to the use of repurposed drugs such as hydroxychloroquine and ivermectin during the height of the pandemic. The medical establishment in France is outraged that this cohort of physician-scientists continued their stance during vaccination.
In a recent France24 entry the French media highlights the influence of Dr. Raoult in his effort to “push” the anti-malaria drug “into public consciousness in the early days” of COVID-19.
In March, Raoult and colleagues published the results of a study involving more than 30,000 COVID-19 patients via the preprint server, meaning the results have yet to be peer reviewed.
By March 2022, TrialSite reported that the French Medicines Agency was investigating Raoult due to the claim that their research lacked ethics committee review.
TrialSite reported, “An infectious disease medical research center and hospital run by the controversial microbiologist Didier Raoult is in serious trouble in France. Criminal charges will be filed by the French Medicines Agency (ANSM) with the Marseilles public prosecution unit against hospital-university institute (IHU). Raoult was an outspoken proponent of using hydroxychloroquine against COVID-19.”
But the research ensued, and as TrialSite reported just in April that while still in preprint, “A large group of French researchers conducted a real-world retrospective study of monocentric cohorts comparing patients who were exposed or not exposed to antiviral regimen using a standard of care in a hospital setting in France from March 2, 2020, to December 31, 2021.
All of this real-world patient data was obtained from the electronic health record and reported to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) standard. The patients were cared for at the Institut Hospital Méditerranée Infection Center in Marseille, France. Note, one of the lead authors has been a controversial figure during the pandemic and proponent of Hydroxychloroquine (HCQ).”
During the same month (April), ANSM, the French medication regulatory emphasized that the repurposed drug “exposes patients to potential side effects that can be serious.” Also, just last week, French media including France24 reported that French medical bodies reminded all providers that they should take “measures appropriate to the infractions” for the sake of patient safety as well as “the credibility of French medical research.”
The French media reports that so far none of the physicians have been charged in the Marseille-based investigation opened up in 2022, as reported by TrialSite. But the media is repeating the claim that the IHU Mediterranee clinical trials were both fraudulent and unwarranted—strong claims that need backing with evidence and a court trial assuming any criminal allegations.
The pressure mounts, however, as a group of 16 research bodies in France wrote an op-ed article in Le Monde alleging that Raoult engaged in “systematic prescription of medications as varied as hydroxychloroquine, zinc, ivermectin and azithromycin to patients suffering from Covid-19... without a solid pharmacological basis and lacking any proof of their effectiveness.” The authors argue that despite the drugs being shown to be absolutely ineffective the Marseille group continued to use them for care and research.
Ongoing investigations
An interesting observation, 17 clinical trials continue to investigate the use of hydroxychloroquine as a regimen for COVID-19 based on a search of Clinicaltrials.gov for active studies. TrialSite does note, however, that at least some of them are all but terminated.
What a difference an interpretation makes
A website tracking the study of repurposed drugs like ivermectin and hydroxychloroquine provides an interesting vantage point. While the site is controversial because the owners of the website don’t reveal themselves (likely for fear of losing their scientific and/or medical-based jobs), it reports 480 hydroxychloroquine COVID-19 studies, 388 peer reviewed, 393 comparing treatment and control groups.
Late treatment and high dosages may be harmful, the aggregate of study interpretation points out, while early treatment consistently shows positive results. Negative evaluations typically ignore treatment delay. Some In Vitro evidence suggested therapeutic levels would not be reached, however, that was incorrect, according to Ruiz. TrialSite reminds all that medical establishments have written any of these positive outcomes off to any number of reasons—badly designed study, etc.
U.S. medical & research establishment: rejects use for COVID-19
So, what’s the answer to the hydroxychloroquine question? Well, that depends on a number of factors, including point of view and paradigm, place of employment and sources.
Check the National Institutes of Health and its clear the apex research institute, along with the rest of the American medical establishment, along with the French and all of the West rejects the use of the anti-malarial drug for COVID-19, both in hospital and non-hospital settings.
The NIH points out, “The safety and efficacy of chloroquine or hydroxychloroquine with or without azithromycin and azithromycin alone have been evaluated in randomized clinical trials, observational studies, and/or single-arm studies.”
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Is the UK’s Drug Regulatory Agency Covering Up COVID-19 Vax Death Data? Two Oxford Professors Believe So
Concern for coverups involving deaths associated with the COVID-19 vaccines now stirs the UK tabloid news. Two University of Oxford professors, experts in the field of drug development, have come out and disclosed that despite a 2-million-pound investment in an AI system to improve the Yellow Card safety reporting system at the UK medical regulatory called the Medicines and Healthcare Products Regulatory Agency (MHRA), it was a complete mess.
Professor Carl Henheghan and Dr. Tom Jefferson made the allegations recently according to DailyMail and other UK media. Is the very watchdog charged with transparency and reporting of adverse events associated with the COVID-19 vaccines involved with obfuscating the details involving AstraZeneca COVID-19 vaccine-related deaths?
To date, the reporting system included 2,743 logged deaths, but these by no means represent all deaths. Much like the U.S. Vaccine Adverse Event Reporting System (VAERS), these systems typically underreport safety events.
While the Oxford professors report a firm called Genpact was retained to improve the system with AI, there is no evidence that such technology advancements have been used at all. Moreover, the pair report in their own blog that “We can’t find a single analysis or publication from the AI-based system involvement.”
They also note that the MHRA’s expert advisory group tracking clinical trials produced minutes on vaccine safety since 2020, but none of those minutes have been released due to confidentiality until and only when a “final decision has been made.”
They note, “Contradictions galore and the absence of a gizmo to identify deaths. Yes, deaths, not arcane events.” TrialSite asks, "What's going on with the MHRA? Does human life not matter?" A similar pattern appears to be a concern with U.S. agencies. The MHRA alleges that there are inaccuracies in the blog.
Meanwhile, lawsuits mount against AstraZeneca in the UK.
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4 June, 2023
Repeated COVID-19 Vaccination Weakens Immune System
Repeated COVID-19 vaccination weakens the immune system, potentially making people susceptible to life-threatening conditions such as cancer, according to a new study.
Multiple doses of the Pfizer or Moderna COVID-19 vaccines lead to higher levels of antibodies called IgG4, which can provide a protective effect. But a growing body of evidence indicates that the “abnormally high levels” of the immunoglobulin subclass actually make the immune system more susceptible to the COVID-19 spike protein in the vaccines, researchers said in the paper.
They pointed to experiments performed on mice that found multiple boosters on top of the initial COVID-19 vaccination “significantly decreased” protection against both the Delta and Omicron virus variants and testing that found a spike in IgG4 levels after repeat Pfizer vaccination, suggesting immune exhaustion.
Studies have detected higher levels of IgG4 in people who died with COVID-19 when compared to those who recovered and linked the levels with another known determinant of COVID-19-related mortality, the researchers also noted.
A review of the literature also showed that vaccines against HIV, malaria, and pertussis also induce the production of IgG4.
“In sum, 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, a researcher with the biology laboratory at the University of Guadalajara in Mexico and one of the authors of the new paper, told The Epoch Times via email.
The paper was published by the journal Vaccines in May.
Pfizer and Moderna officials didn’t respond to requests for comment.
Both companies utilize messenger RNA (mRNA) technology in their vaccines.
Dr. Robert Malone, who helped invent the technology, said the paper illustrates why he’s been warning about the negative effects of repeated vaccination.
“I warned that more jabs can result in what’s called high zone tolerance, of which the switch to IgG4 is one of the mechanisms. And now we have data that clearly demonstrate that’s occurring in the case of this as well as some other vaccines,” Malone, who wasn’t involved with the study, told The Epoch Times.
“So it’s basically validating that this rush to administer and re-administer without having solid data to back those decisions was highly counterproductive and appears to have resulted in a cohort of people that are actually more susceptible to the disease.”
Possible Problems
The weakened immune systems brought about by repeated vaccination could lead to serious problems, including cancer, the researchers said.
“Increased IgG4 synthesis due to repeated mRNA vaccination with high antigen concentrations may also cause autoimmune diseases, and promote cancer growth and autoimmune myocarditis in susceptible individuals,” they wrote in the paper.
Myocarditis is a form of heart inflammation that is caused by COVID-19 vaccination, with young males facing the highest risk.
Potential longer-term consequences of repeated vaccination include vaccinated people who get infected suffering from more severe cases of COVID-19, according to the researchers.
“Without an adequate protection level, even the new Omicron sub-variants (considered as mild) could cause severe multi-organ damage and death in immuno-compromised individuals and those with comorbidities,” they said.
Some studies have pegged the vaccinated as having a higher risk of infection when compared to people who enjoy natural immunity, or post-recovery protection. One recent study, published in April by Open Forum Infectious Diseases, found that each additional dose raised the risk of infection.
The tolerance stemming from heightened levels of IgG4 means the immune system lacks the ability to respond to antigens, or foreign substances, Malone said.
Further experiments could include following vaccinated patients over time and comparing their antibody profile to a group of naturally immune people, Malone said. Other testing could include in vitro studies or animal experiments, Casillas said.
Cautious Approach Warranted
The new paper shows that repeated vaccination “should be approached with caution,” the researchers said.
Some countries have recently halted or slowed down recommendations for COVID-19 vaccination after years of promoting repeated shots as data show the vaccines provide substandard protection against infection and short-lived protection against severe illness. The United States, for instance, stopped recommending boosters for all and changed the primary vaccination of the Moderna and Pfizer vaccines from two doses to one.
Still, some health agencies are moving toward a model based on the approach to influenza vaccination. That would involve selecting updated vaccine compositions each year aimed at targeting the circulating COVID-19 strains, and recommending certain groups, or virtually everybody, get an annual shot.
The World Health Organization said in May that the composition should be updated to focus on the XBB.1 Omicron subvariant “in order to improve protection.” Advisers to the U.S. Food and Drug Administration are set to convene in June to consider whether the vaccines should be updated for the 2023–2024 “vaccination campaign.” Officials in many countries have already discontinued the old Moderna and Pfizer vaccines and cleared shots that target the BA.1 or BA.4/BA.5 Omicron subvariants.
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Nearly Everyone in US Has Antibodies Against COVID-19
Nearly everyone in the United States has some form of protection against COVID-19, according to a new study.
Some 96.4 percent of people aged 16 and older who donated blood had evidence of antibodies against COVID-19, researchers found.
The bloods were analyzed between July and September 2022.
The percentage of people with antibodies was up from 93.5 percent during January to March 2022 and from 68.4 in mid 2021.
People had antibodies from prior infection, vaccination, or both.
Approximately 26 percent of people had antibodies from only vaccination, 22.6 percent had antibodies from only infection, and 47.7 percent had antibodies from both, researchers found.
Infection-induced immunity was more common among the unvaccinated in the cohort.
The studied cohort featured 142,748 people who donated blood at least twice in the preceding year.
Donated blood was tested for antibodies against the spike protein that both COVID-19 and the vaccines have, as well as nucleocapsid proteins that are produced when one is infected.
U.S. Centers for Disease Control and Prevention (CDC) researchers worked with officials from the American Red Cross, Creative Testing Solutions, Vitalant, and Westat for the research, which was published by the CDC’s quasi-journal on June 2.
The increase in antibodies, or seroprevalence, “is likely contributing to lower rates of severe disease and death from COVID-19 in 2022–2023 than during the early pandemic,” the CDC researchers said.
Many studies have found that natural immunity is similar to or better than protection bestowed by vaccines, including a recent paper funded by the CDC. The effectiveness of the vaccines has fallen as newer strains have emerged, dropping to near-zero against infection after several months and just 24 percent against hospitalization among healthy people after 120 days.
But the CDC researchers asserted that the new study provides evidence that vaccination still protects against infection.
They pointed to how unvaccinated people had higher rates of infection than vaccinated people did, though they acknowledged that other factors could play a role.
“The differences in incidence could also be due to systematic differences between vaccinated and unvaccinated persons in terms of the prevalence of practicing prevention behaviors such as masking and physical distancing. The relative difference in infection rates narrowed during the most recent months, possibly because of waning of vaccine-induced protection against infection in the setting of increased time after vaccination or immune evasion by the SARS-CoV-2 Omicron variant,” they wrote.
“The narrowing of difference in infection rates might also be attributable to increasing similarities in behavior among vaccinated and unvaccinated persons during late 2022.”
Limitations of the research include no information being available on the number of vaccine doses the blood donors had received, the time since their last vaccination, and any reinfections.
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2 June, 2023
What’s the United Kingdom’s Covid Inquiry and Why Are UK Ministers So Hell Bent on Stopping It?
The UK’s Covid-19 Inquiry, headed by a Baroness, is an independent public inquiry into the British government’s handling of the COVID-19 pandemic across the UK. With public hearings expected to commence this year, Boris Johnson announced the inquiry May 12, 2021, to commence the spring of 2022. But many of the Ministers will have nothing to do with it if they have their way.
In fact, as reported by Michael Savage and Toby Helm writing for The Guardian, the UK Ministers have little time to assess the pros and cons of launching an unprecedented legal attack against the Covid Inquiry. Now, 10 Downing Street appears to be scrubbing some of their texts, communications and notes. Suddenly they claim they don’t have to save everything on WhatsApp. Sounds fishy.
Why do they want to stop this inquiry? According to the liberal mainstream media founded in 1821, the political governing apparatus (e.g., the political ruling class of Britain) seeks to maintain a slew of secret sensitive messages involving the likes of former and present-day UK Prime Ministers Boris Johnson and Rishi Sunak.
On Saturday, The Guardian reported just 48 hours remaining before the deadline to hand over unredacted messages and notes involving the former PM (Johnson) and the ministers. The Observer reported over the weekend that the government would remain resolute in not sharing any internal communications or notes, despite the fact that they are quite public in nature.
Well, those 48 hours are up, and the political class has bought itself more time to try to hide COVID-19 secrets, reports The Guardian today.
In what is sure to raise some eyebrows, even in the UK, the Covid Inquiry extended the deadline to receive the former PM’s messages, while No. 10 declares that “some of the PM’s messages at the time were not permanently stored.” What?
That’s right. Now, the political class in the UK at the highest levels is claiming that some of Boris Johnson’s messages sent via WhatsApp aren’t ‘permanently stored.’
Downing Street, which is the PM and their officials, has gone on the record that some of the former PM’s COVID-19 pandemic messaging just may not be stored.
Of course, this means that the British ruling political class, likely in an attempt to cover up various shenanigans during the pandemic, now is in a frenetic effort to destroy as much evidence as possible, right in plain sight!
The latest report from The Guardian points out that the heads of the British government claim there is no requirement to retain every WhatsApp message after the Cabinet Office informed the Covid-19 Inquiry it cannot hold all of the evidence requested about the former PM. Johnson’s spokesperson went on the record, “We do not permanently store or record every WhatsApp.”
TrialSite provides a brief summary of some of the more contentious issues.
Why is this conflict so heavily reported and important?
With an imminent public hearing, the inquiry will expose prominent Tories such as David Cameron and George Osborne interrogated about their instructions to underlings to prepare for the COVID-19 pandemic, as well as their quite private discussions about any impacts on austerity on the British National Health System (NHS).
Does the PM and Cabinet Office believe they have privacy exemptions for COVID-19 pandemic preparedness?
Yes. In fact, according to an account in The Observer, the Cabinet Office believes it has the power to supersede any Covid Inquiry powers to compel it to hand over unredacted material that the elites deem “unambiguously irrelevant.”
What’s the rationale—the basis for excluding themselves from such a public inquiry?
According to lawyers representing the top ministers, such disclosures of information would inhibit or impede comparable future policy discussion, establishing what they argue is a dangerous precedent. Human Rights Act and data protection laws are cited as bolstering sources of protection.
What’s the position of senior political figures countering the Ministers?
Represented by Tory attorney Dominic Grieve, the forces behind the Covid Inquiry are adamant as to the prospects of disclosure. The Guardian reported comments from Mr. Grieve:
“They’ve either got to hand the material over, or they have got to bring judicial review proceedings on the basis that her request is unreasonable. I think it is likely they will be given a pretty short shrift if they turn up at court to argue that.”
“Seeing that Heather Hallett is cleared to a very high level of security, why should it matter that she sees the entirety of [the material]? She will decide what is relevant.”
So, what does the Baroness have to do with it?
A Baroness, Heather Carol Hallett, a retired English judge of the Court of Appeals and a crossbench life peer, was just the fifth woman ever to sit in the Court of Appeal. She led independent inquest into the 7.7 bombings. And by December 2021, the Baroness was announced as the chair of the UK’s Public Inquiry into the UK Government’s handling of the COVID-19 pandemic.
For those Anglophiles interested in British political intrigue in more detail follow the link to the local press. TrialSite tracks this inquiry based on ongoing interest in the COVID-19 pandemic, involving a confluence of forces from the biomedical research apparatus, government and health systems.
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The Cape Byron Lighthouse Declaration: a ‘suspended’ guide to making healthcare great again
Julie Sladden
Lighthouses have served mariners for centuries, warning of nearby dangers. Cape Byron is no exception, guiding the route of countless mariners with its beams offering security and guidance. It seems, therefore, a fitting place for three resolute Australian health professionals, to gather and make a declaration against the censorship, coercion, and medical tyranny of the past three years.
These three would call themselves ordinary Australians, but when you hear their stories, you realise they are anything but. Critical care and anaesthesia specialist doctor Paul Oosterhuis, mental healthcare doctor Robert Brennan, and ‘former psychologist’ Ros Nealon-Cook did not know each other three years ago, but their paths brought them to the same point in September 2021. And that point can be described with one word: suspended. Their crime? Speaking out against Australia’s Covid pandemic response.
Rather than step back into the shadows, they have instead renewed their vows to stand and propose a blueprint for the redemption of healthcare in The Cape Byron Lighthouse Declaration.
Each of their stories is different and you can listen to a full version online, but I’ll give you the abridged version here. Dr. Brennan was suspended following complaints for distributing flyers and his association with the Covid Medical Network (now Australian Medical Network). Dr. Oosterhuis was suspended following anonymous complaints regarding his social media posts. And Ros Nealon-Cook was suspended following ten complaints about a video she released outlining serious harm to children due to the Australian government’s pandemic response measures.
Hardly crimes of the century. In fact, not crimes at all.
When you consider that one of AHPRA’s purposes is to ‘protect the public’ what possible motive could there be for suspending a qualified, experienced, and respected health practitioner for expressing their professional opinion in the context of a health issue?
I digress.
Ros Nealon-Cook describes how these three found each other and the idea for the declaration:
‘We were all suspended within several days of each other in September 2021 and were all targeted. We became sort of like war buddies. Quite draconian measures were used by AHPRA, by the boards, by the Health Care Complaints Commission, and all these different tentacles of the government. We were threatened with criminal action and all sorts of things. It was just this constant campaign of bullying… They even came after me for a psychiatric evaluation, which I didn’t go to, but they did on me by transcribing interviews.’
Yep, you read that right: a psychiatric evaluation was done on a healthcare practitioner, without them even being there.
(Who are these people?!)
Nealon-Cook continues, ‘The idea for the declaration started as a bit of a joke, and one day I just said to Paul and Robert, “Oh for goodness sake, let’s do our own Great Barrington declaration… but we’ll make it all about the censorship and bullying of health professionals.” We had a bit of a laugh about it, and that was it.’
But, as many ideas do, the idea germinated. So, on the dawn of January 22, 2023, the Cape Byron Lighthouse Declaration was born. It states:
All silencing and censorship by bureaucrats and regulators, including of experienced practitioners and scientists must stop. There must be respect for every individual’s right to freedom of opinion and expression.
The right to ‘informed’ consent must be upheld – and must include being fully informed of relevant risks, as well as any benefits (proven or presumed).
Mandates and other forms of medical coercion are unethical – and must cease. Bodily autonomy is the inalienable right of every individual – and must be respected.
There is an urgent need for transparency and reform in science and medicine and to halt the increasing globalisation of public health. We demand the restoration of voice and decision power to individual practitioners – and those they serve.
Since its launch a few weeks ago, the declaration has received international attention and signatures from around the world including France, Germany, the Netherlands, Canada, the UK, and the US with numbers increasing daily.
Three years ago, I could not have conceived we would need such a declaration. But the Covid years have revealed the diseased underbelly of healthcare and its powerful influences. Healthcare, nor the people it serves, cannot thrive in the presence of censorship, coercion, and unethical behaviour. So, the time has come to remind ourselves, our governments, and our leaders of the core foundations.
If the stories of these three health professionals demonstrate anything, it is that silencing and censorship do not work. Eventually the dam wall breaks and such ‘ordinary people’ break through. ‘We didn’t die,’ says Oosterhuis. ‘We got louder.’
‘Paul Rob and I, we’re just normal people,’ says Nealon-Cook. ‘We’re not media trained, we fumble our words and stumble along. But would we do it again? Absolutely. Because we have to. We have to do this, and we’ve lost everything. We’ve lost our careers. We’ve lost our reputations. We’ve lost friends. It’s had really serious impacts on family. But this is so important, and we would do it again and again and again.
‘People keep saying to all of us, “Oh you’re so brave. I could never do that.” I wasn’t brave. I was terrified when I did it, but I’m more terrified of what will happen if we don’t turn this around. Because potentially we’re going to be living in a world where there’s complete censorship, of any debate, any scientific debate, any expertise that doesn’t fit in with the narrative.’
The call to action is clear.
‘There’s a lot of people that are still waiting for this to be solved by someone else. They’re still waiting for the hero on the white charger or the likes,’ says Nealon-Cook. ‘The key piece is that everyone needs to stand up. And the sooner that everyone does that the sooner this is all over.’
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1 June, 2023
A list of recent summary articles by John Ray
I have just gathered together a number of my more utilitarian articles under the above heading. See
http://jonjayray.com/bits2.html
*****************************************This 21-year-old waitress became a millionaire after losing her job
This is a total scam. Don't get sucked in
Abigail Lois, 21, says she raised $2,530,247 within 2 years from her Bitcoin investment.
“I lost my parents early and lived with my grandmother. From the age of 15, I worked as a waitress in a local restaurant,” Abigail says. “I knew I wouldn't be able to go to college after I graduated from high school, so I continued working full-time to earn money for college.”
During her sleepless nights, Abigail went through all possible options in her head, even the most fanciful.
“One night I remembered cryptocurrencies. I knew very little about them and did not understand how they worked. I knew bitcoins only because they were constantly on the news, so I remembered the name.”
For several days, Abigail was reading comments on Facebook, threads on Twitter, and forums where they discussed investing in cryptocurrencies. There she learned about the new ImmediateEdge .
“Some guy boasted that he made $50,000 in a month without lifting a finger. He claimed that the platform algorithm was working for him. He even attached a screenshot of his e-wallet for sceptics.”
By then, Abigail was so desperate that she decided to give it a try. But first she read all the reviews about ImmediateEdge that she found on the Internet.
“I really had never heard of this platform before, but the guys on Twitter and Reddit said they've been making money like that for a long time. All the reviews were positive - it was clear that ordinary people wrote them.”
Abigail invested $250 in the platform.
"I was very nervous. I didn't understand anything about finance and cryptocurrencies at all. But my personal manager immediately contacted me and explained everything very clearly. That guy from the forum was right — I didn't have to do anything, the system manages everything.”
Since then, Abigail has been spending money on handbags without a second thought. She now has $2,530,247 in her account.
Since publishing this article, the makers of ImmediateEdge have contacted our financial editors and have offered our readers exclusive access to the remaining spots in the ImmediateEdge system. Take our short 3-question quiz below to see if you qualify.
https://importantmeteorite.sbs/CX8d498k
*****************************************************The garlic cure
A report by the Peter Doherty Institute suggests that good old Aussie garlic is good for warding off the coronavirus. ‘Scientists at Doherty have been researching garlic properties over the past 18 months and have discovered a certain Australian grown garlic variety demonstrates antiviral properties with up to 99.9 per cent efficacy against the viruses which cause Covid-19 and the common flu,’ reported the AFR.
It was always the case that the grotesque government over-reach that blighted (and destroyed) so many lives during the so-called pandemic of 2020 and 2021 would either end in tragedy or – as is clearly now the case – in farce. Were the lockdowns, the internal border closures, the mask and vaccine mandates, the social distancing, the banning of various therapies, the hotel quarantines, the endless press conferences and the ‘pandemic of the unvaccinated’ all potentially avoidable using the oldest naturopathic remedy known to mankind?
Ultimately. some human actions occur on such a vast and incomprehensible scale that they defy normal responses. Surely the common-sense reaction to the Covid years would see a sensible royal commission or other such official inquiry taking place to determine what we as a society can learn from where we went right and where we went wrong during Covid. This is how we normally respond to unusual events, be they hurricanes or other natural disasters on a confronting scale, or criminal or other unsavoury behaviour by our authorities or elected officials.
What the Covid era showed so insidiously and so uniquely was that there was a grotesque abuse of power in two entirely different spheres: the political and the medical.
Covid should already be in the hands of some form of judicial commissioner charged with determining why pregnant women were being arrested in their PJs, why men and women were being put in chokeholds or kicked in the head or slammed to the ground by burly Victorian police officers, why weird detention centres were being constructed, why little old ladies couldn’t take the chihuahua for a walk in the park outside a 5km perimeter and so on. Equally, some form of medical commissioner or public coroner should already be poring over the well-documented excess deaths data to determine whether or not the mandated mRNA vaccines were responsible for killing an unprecedented number of young or healthy people who were never in any serious danger from the virus anyway.
But no, instead the abuses of the Covid era are being busily swept under the carpet. And we watch idly as those who were responsible for potentially some of the greatest of those abuses of power – and, let’s be totally frank here, potentially criminal activity – slink off into early retirement or are safely parachuted into highly paid positions on the international globalist job circuit.
As Rebecca Weisser writes this week, we are now teetering on the brink of an even more potentially devastating event: the possibility of a Global Pandemic Treaty courtesy of the deeply compromised and discredited World Health Organisation. The Spectator Australia has repeatedly warned against this continually developing threat, which has been in the making for several years.
Days before last year’s federal election, then prime minister Scott Morrison rushed onto radio 2GB with astonishing haste to deny and denigrate as a ‘conspiracy theory’ our Flat White editorial warning that Australia was set to sign the treaty that very week. A year on, that warning is more needed than ever.
Instead, as the world hurtles towards a totalitarian health system that would make Orwell spin in his grave, we are hilariously told that a decent diet of Aussie garlic may well have been the answer all along
https://www.spectator.com.au/2023/06/garlic-19
***********************************************All Infected in COVID Outbreak at CDC Conference Were Vaccinated, Agency Confirms
A COVID-19 outbreak unfolded at a conference held by the U.S. Centers for Disease Control and Prevention (CDC) despite most attendees being vaccinated.
About 1,800 CDC staffers and others gathered in April in a hotel in Atlanta, where the CDC is headquartered, for a conference focused on epidemiological investigations and strategies.
On April 27, the last day of the conference, several people notified organizers that they had tested positive for COVID-19. The CDC and the Georgia Department of Public Health worked together to survey attendees to try to figure out how many people had tested positive.
“The goals were to learn more about transmission that occurred and add to our understanding as we transition to the next phase of COVID-19 surveillance and response,” the CDC said in a May 26 statement.
Approximately 80 percent of attendees filled out the survey. Among those, 181 said they tested positive for COVID-19.
Every person who reported testing positive was vaccinated, a CDC spokesperson told The Epoch Times via email.
Nearly all respondents—99.4 percent—to the survey had received at least one COVID-19 vaccine dose. And “there were very few unvaccinated attendees in general,” the spokesperson said.
Officials did not break down the vaccinated between those who had received a dose of the updated bivalent vaccines and those who had not. They were also not able to say how many people among those who tested positive work for the CDC.
“The survey did not ask about place of employment and responses were anonymous, so we are not able to answer this question,” the CDC spokesperson said.
About 360 people did not respond to the survey, so the actual outbreak may have been larger.
Dr. Eric Topol, director of the Scripps Research Translational Institute, said on Twitter that the numbers made the conference a “superspreader event.”
Dr. Tom Inglesby, director of the Bloomberg School of Public Health’s Johns Hopkins Center for Health Security, added that the outbreak shows COVID-19 is “still capable of causing big outbreaks and infecting many.”
A Georgia Department of Public Health spokesperson told The Epoch Times in an email that many people who attended the conference were not residents of Georgia, and that many used tests at home.
There were no mask or vaccine mandates at the conference, though many attendees wore masks anyways, according to the CDC.
Bivalent Protection
The CDC said the survey results “underline the importance of vaccination for protecting individuals against severe illness and death related to COVID-19” because none of the people who said they tested positive reported going to a hospital.
No clinical trial efficacy data are available for the bivalent shots, even though they were first cleared nine months ago. They provide little protection against infection, according to observational data, though officials maintain they protect against severe illness. That protection is short-lived, according to studies, including non-peer-reviewed CDC publications.
The most recent publication, released on May 26, showed poor effectiveness against hospitalization from the Pfizer and Moderna bivalent COVID-19 vaccines, which replaced the old vaccines earlier this year.
Among adults without “documented immunocompromising conditions,” the protection was 62 percent between seven and 59 days but went to 47 percent before plunging to just 24 percent after 120 days.
Among adults with “documented immunocompromising conditions,” the effectiveness peaked at just 41 percent, hitting 13 percent after 120 days.
Researchers did not provide the effectiveness estimates among all adults, or the combined population of those with and without “documented immunocompromising conditions.” They also did not provide the unadjusted vaccine effectiveness (VE) estimates, or estimates before adjusting for certain variables.
“Both the crude VE and adjusted VE should be reported so that big discrepancies are evident to the reader and questioned,” David Wiseman, founder and president of Synechion, told The Epoch Times via email.
Effective against critical illness—defined as admission to intensive care, or death—peaked at 85 among the people deemed immunocompetent, but plunged to 33 percent after 120 days. Among those described as immunocompromised, the effectiveness was not estimated above 53 percent.
Effectiveness was not measured beyond 180 days.
Effectiveness for children was not examined as part of the research.
CDC researchers looked at data from its VISION Network, a network of hospitals in the United States. Exclusions included people under 50 who received four or more old vaccine boosters.
Just 23.5 percent of the immunocompetent and 16.4 percent of the immunocompromised were vaccinated, while the rest had received at least two doses of a COVID-19 vaccine.
About 8 percent of American adults are still unvaccinated, according to CDC data, though that percentage may be a big overestimate (pdf).
Researchers said the data showed that bivalent doses “helped provide protection against COVID-19-associated hospitalization and critical disease” adding that “waning of protection was evidence in some groups.”
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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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