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FDA Vaccine Committee Member Calls For End to Mass Covid Vaccination

“We should stop trying to prevent all symptomatic infections in healthy, young people.”

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Dr. Paul Offit, a member of the U.S. FDA’s vaccine advisory committee, has written in the New England Journal of Medicine, the world’s top medical journal, calling for an end to the mass vaccination of anyone at low risk from the virus.

In an op-ed titled “Bivalent COVID-19 Vaccines – A Cautionary Tale”, Dr. Offit writes that Covid boosters are “probably best reserved for the people most likely to need protection against severe disease”.

“I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later,” he writes.

Dr. Offit, who is Professor of Vaccinology and Professor of Paediatrics at the University of Pennsylvania, goes through in detail the process that led to bivalent vaccines being recommended in the U.S. for everyone over five years of age with no relevant data from humans. He is clearly very unhappy about it.


On June 28th 2022, researchers from Pfizer-BioNTech and Moderna presented data on their bivalent vaccines to the FDA’s Vaccines and Related Biological Products Advisory Committee (of which I am a member). The results were underwhelming. Bivalent boosters resulted in levels of neutralising antibodies against BA.1 that were only 1.5 to 1.75 times as high as those achieved with monovalent boosters. Previous experience with the companies’ vaccines suggested that this difference was unlikely to be clinically significant. Safety data were reassuring. At the time of the FDA presentation, BA.1 was no longer circulating in the United States, having been replaced by more immune-evasive and contagious Omicron subvariants. But winter was around the corner. The FDA advisory committee, sensing the urgency of responding to these immune-evasive strains, voted to authorise bivalent vaccines with an understanding that they would target Omicron subvariants BA.4 and BA.5, which at the time had accounted for more than 95% of circulating strains.

A series of rapid-fire policy decisions followed. On June 29th 2022, the day after the advisory committee meeting, the Biden administration agreed to purchase 105 million doses of Pfizer-BioNTech’s bivalent vaccine containing BA.4 and BA.5 mRNA. One month later, on July 29th 2022, the administration agreed to purchase 66 million doses of Moderna’s bivalent vaccine, intending to offer both vaccines in the fall and winter. On September 1st 2022, the FDA withdrew its emergency use authorisation for monovalent vaccine boosters and the CDC recommended bivalent vaccine boosters for everyone 12 years of age or older. On October 12th 2022, the CDC extended this recommendation to include everyone five years of age or older. At that point, no data from humans, including immunogenicity data, were available for comparing the relative capacities of the monovalent and bivalent vaccines to protect against BA.4 and BA.5.

On October 24th 2022, David Ho and colleagues released the results of a study examining levels of neutralizing antibodies against BA.4 and BA.5 after receipt of a monovalent or bivalent booster dose. They found “no significant difference in neutralisation of any SARS-CoV-2 variant”, including BA.4 and BA.5, between the two groups. One day later, Dan Barouch and colleagues released the results of a similar study, finding that “BA.5 [neutralising-antibody] titers were comparable following monovalent and bivalent mRNA boosters”. Barouch and colleagues also noted no appreciable differences in CD4+ or CD8+ T-cell responses between participants in the monovalent-booster group and those in the bivalent-booster group. Neither research group found the bivalent boosters to elicit superior immune responses. The results are now published in the Journal.

The likely reason the bivalent vaccines failed is immune imprinting, Dr. Offit explains.

The immune systems of people immunised with the bivalent vaccine, all of whom had previously been vaccinated, were primed to respond to the ancestral strain of SARS-CoV-2. They therefore probably responded to epitopes shared by BA.4 and BA.5 and the ancestral strain, rather than to new epitopes on BA.4 and BA.5.

When epidemiological data did become available, they showed very poor protection.

On November 22nd 2022, the CDC published data on the effectiveness of the BA.4 and BA.5 mRNA vaccines for preventing symptomatic infection within two months after receipt of the booster dose. For people who had received a monovalent vaccine two to three months earlier, the extra protection associated with the bivalent booster dose ranged from 28% to 31%. For those who had received a monovalent vaccine more than eight months earlier, the extra protection ranged from 43% to 56%. Given the results of previous studies, it’s likely that this moderate increase in protection against probably generally mild disease will be short lived.

The bivalent vaccine had very poor take-up and the variants it was targeted against were quickly gone.

As of November 15th 2022, only about 10% of the population for whom the bivalent vaccine had been recommended had received it. By December 2022, the BA.4 strain was no longer circulating, and BA.5 accounted for less than 25% of circulating SARS-CoV-2 strains, having been partially replaced by more immune-evasive strains, such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1.

It’s welcome that Dr. Offit is breaking ranks and expressing dismay about the poor process and the lack of data, and calling for the end of the mass vaccination campaign. The intervention is particularly significant because it denotes a failure of the central U.S. biosecurity strategy of trying to use fast-track mRNA vaccines to provide a lightning response to an emerging biological threat. It is thus likely that his conclusions will be strongly resisted by those who are invested – financially, psychologically and politically – in this strategy.

That Dr. Offit is only doing so now, and not with any recognition of any safety problems, is less welcome, of course. Still, he will likely not be thanked by his paymasters, and it is in the right direction, so he should receive credit for that.

We still await the acknowledgement that the benefit of these vaccines was never favourable for people at low risk from the virus, who never needed them, and that their safety profile is far worse than the companies and regulators have led the public to believe.

Stop Press: CNN reports that Dr. Offit is “angry” that Moderna failed to include unfavourable infection data in its submission to the FDA last year. “I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” Dr. Offit said. According to CNN: “The data that was not presented to the experts looked at actual infections: who caught COVID-19 and who did not. It found that 1.9% of the study participants who received the original booster became infected. Among those who got the updated bivalent vaccine – the one that scientists hoped would work better – a higher percentage, 3.2%, became infected.” Does it make you wonder what else they’re not telling you, Dr. Offit?

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Coronavirus

Anger As Biden Admin Hands Another $2.3 Million To EcoHealth Alliance To Research Bat Coronaviruses

What could possibly go wrong… again?

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Steve Watson

Igor Golovniov/SOPA Images/LightRocket and HECTOR RETAMAL/AFP via Getty Images

Republican lawmakers have labeled as “absolutely reckless” a decision to grant a further $2.3 Million to the very same outfit at the centre of the likely coronavirus lab leak that led directly to a the global pandemic.

As reported by The Daily Mail, The Biden Administration, via the National Institutes of Health (NIH), has renewed the taxpayer grant to EcoHealth Alliance to research bat coronaviruses over the next four years, with the proviso that no gain of function activity is carried out.

The funding was previously blocked when it emerged that zoologist Peter Daszak had enabled the funnelling of the money to the Wuhan Institute of Virology, where the research into making the virus more deadly was carried out.

Rep. Morgan Griffith, R-Va., who sits on the House Energy and Commerce Committee said “It’s absolutely reckless that the NIH has renewed a grant for EcoHealth Alliance given their negligence and the breach of their contract with the NIH on the coronavirus research done at the Wuhan Institute of Virology.”

Griffith added that EcoHealth has “not been contrite” about the Wuhan lab connection and has actively refused to cooperate with Congressional investigations.

“Until they can demonstrate a willingness to work with Congress to resolve outstanding questions and fulfill all of the terms of their federal contracts, paid for with American taxpayer dollars, all funding should remain suspended, and no new contracts should be awarded,” Griffith urged.

GOP Senator Joni Ernst of Iowa added that the renewal of the NIH grant “doesn’t pass the COVID smell test,” further noting that “Ecohealth has already betrayed the trust of American taxpayers by funneling funds to China’s Wuhan Institute of Virology for risky experiments on bat coronaviruses that may have unleashed the COVID-19 pandemic on the world.”

“Americans deserve accountability, which is why it’s past time to defund EcoHealth,” she added.

Kentucky Congressman James Comer asserted that “It’s bat crazy that the U.S. National Institutes of Health is resuming a suspended grant and allowing EcoHealth Alliance access to taxpayer dollars to conduct research on bat coronaviruses,” adding that the outfit “funneled taxpayer dollars to the Wuhan lab to conduct mad scientist research on bat coronaviruses that may have started the pandemic.”

“EcoHealth shouldn’t receive another dime from the U.S. government until we fully investigate what happened at the Wuhan lab,” Comer emphasised.

Last month, during a House hearing on the origins of the COVID Pandemic, former Director of National Intelligence John Ratcliffe declared that “a lab leak is the only explanation credibly supported by our intelligence, by science and by common sense.”

A Senate report also concluded that the pandemic most likely came from a lab leak and was the result of a “research-related incident” in Wuhan.

The 300-page document notes that the theory that COVID-19 jumped from animals to humans in a market “no longer deserves the benefit of the doubt, or the presumption of accuracy.”

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    Video: Rand Paul Accuses USAID Administrator Of Stonewalling COVID Origins Investigation

    The Senator grilled Samantha Power during hearing Wednesday

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    Steve Watson

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    Senator Rand Paul grilled Samantha Power, Administrator of the U.S. Agency for International Development (USAID), during a Senate Foreign Relations Hearing Wednesday, accusing Power of working to withhold information requested by Republicans on the origins of COVID-19.

    Paul immediately asked Power if USID had funded coronavirus research in Wuhan, China, prompting her to automatically deny any gain of function research took place.

    “That is not the question,” Paul shot back, before noting that huge grants totalling 200 million dollars, under the PREDICT program, were given to coronavirus researchers in China, some of which were stationed at the Wuhan Institute of Virology.

    Paul continued, “In September of last year, I wrote Ms. Power or USAID a request asking for records from the PREDICT program. These are not classified. These are simply records of scientific research. And we want to read the grants to find out what they were doing and whether the research was dangerous or not. The response I got from your agency was USAID will not be providing any documents at this time.”

    “They’re just unwilling to give documents on scientific grant proposals. We’re paying for it. They’re asking for $745 million more in money, and we get no response,” Paul further explained.

    “20 million people died around the world. You’re supposed to be an agency that cares about the death of people around the world. We, you know, talk about starvation and famine and 20 million people died from a virus. And you won’t give us the basic information about what grants you’re funding around the world and who you’re funding,” the Senator continued.

    “The American people think this, that because you won’t respond because you respond with a non-response, that you have something to hide. I don’t know if you have anything to hide or not. I want to see every grant proposal that had to do with coronaviruses that went to China from the U.S. government, from all facets of the U.S. government and every bit of the Biden administration is stonewalling us and will not give us the information…You are not being honest,” Paul asserted.

    Watch:

    In a press release, Paul further noted “this isn’t just a USAID problem of concealing information, this is a Biden administration-wide problem in which there is a concerted effort to withhold critical information from Congress on the origins of COVID-19.”

    Paul notes that Secretary of State Antony Blinken, Secretary of the Department of Human Health Services Xavier Becerra, Secretary of the Department of Defense Lloyd Austin, Acting Director of the National Institutes of Health Lawrence Tabak, and Administrator of the U.S. Agency for International Development Samantha Power have all failed to reply to requests for information from the Senators.

    Last month Paul, who has vowed to find the paper trail for the origins of the COVID lab leak, grilled Blinken and noted that documents related to funding of coronavirus research have not been provided to him despite repeated requests.

    “My question is, what’s the State Department hiding?” Paul asked, adding “Why won’t you give these records to the American people?”

    “We want to read the research grant proposals. We want to read what the people in Wuhan sent back to the State Department saying they did. Which viruses did they create?” Paul further urged.

    “And yet you won’t help us investigate this. You refuse and it makes — it is reminiscent of the countries we criticize for lack of transparency. And yet you sit there and say you’re still going to continue to refuse,” Paul told Blinken.

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    Video: Former Director of National Intelligence Says ‘Lab Leak The Only Credible Explanation For COVID Pandemic’

    “Were this a trial, the preponderance of circumstantial evidence provided by our intelligence would compel a jury finding of guilt”

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    Win McNamee/Getty Images

    During a House hearing Tuesday on the origins of the COVID Pandemic, former Director of National Intelligence John Ratcliffe declared that “a lab leak is the only explanation credibly supported by our intelligence, by science and by common sense.”

    Ratcliffe told Representatives “from a view inside, if our intelligence and evidence supporting a lab leak was placed side by side with our intelligence and evidence pointing to a natural origin or spillover theory, the lab leak side of the ledger would be long, convincing, and overwhelming. While the spillover side would be nearly empty.”

    “Were this a trial, the preponderance of circumstantial evidence provided by our intelligence would compel a jury finding of guilt,” Ratcliffe added.

    Watch:

    Elsewhere during the hearing, Former Deputy Assistant Secretary of State David Feith noted that officials in the State Department were against investigating U.S. funding gain-of-function research relating to the outbreak, suggesting that it could “open a Pandora’s box”.

    The full hearing is below:

    Meanwhile, in the Senate Rand Paul confronted DHS head Alejandro Mayorkas concerning the origins of COVID. Mayorkas tried to avoid answering any questions on it, instead hyping up DHS’ efforts to set up vaccination centres.

    Paul also noted that “The most significant source of disinformation during the pandemic with the most influence and greatest impact on people’s lives was the U.S. government.”

    Paul later appeared on Fox News, noting that there is a “mountain of evidence” that the virus came from a lab and no proof it came from animals.

    Paul further charged that in his role at the National Institutes of Health, Anthony Fauci made a “COVID judgment error that allowed millions to die.”

    The hearings come after a Senate report concluded that the pandemic most likely came from a lab leak and was the result of a “research-related incident” in Wuhan.

    The 300-page document notes that the theory that COVID-19 jumped from animals to humans in a market “no longer deserves the benefit of the doubt, or the presumption of accuracy.”

    The report also states that Chinese researchers appeared to begin development of at least two Covid vaccines at the Wuhan Institute of Virology (WIV) in November 2019, “before the known outbreak of the pandemic”.

    The report is below:

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