Janet Woodcock's decision to unilaterally push through "boosters for all American adults" last week violated standard FDA protocols that call for review by the VRBPAC
Lacking proper data to justify their decision, the FDA just skipped expert review altogether
On September 17, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) rejected Pfizer’s application for emergency use authorization of a third dose of its mRNA shot for all Americans ages 16 and older. The vote against authorization was unanimous. This was a stunning development.
The VRBPAC is a bunch of hand-picked Yes-men and women. They even bring in a slate of ringers depending on the meeting (so-called Temporary Voting Members) who the FDA knows will vote yes. And they all voted no because there was no data to support the application. This came on the heels of the top two FDA vaccine regulators quitting rather than approve booster shots under pressure from the Biden administration.
So how exactly did the FDA then approve booster doses of both Pfizer and Moderna for all American adults (18 and older) two months later (on November 19, 2021)?
What’s wild is that the VRBPAC did not meet to evaluate these new applications at all. The FDA just skipped that step altogether. Janet Woodcock, who brought us the opioid epidemic, unilaterally approved these “booster” doses as one last gift for the cartel before she is replaced by Robert Califf. Under any circumstances, skipping VRBPAC review would be considered reckless. But in this case, where 1.) there is no proper data supporting this use, 2.) these products have been shown to cause considerable harms, and 3.) these products are being recommended for all Americans — skipping VRBPAC review is unconscionable and criminal.
One might think that the FDA simply did not want to get rejected by their expert committee again. But remember, the VRBPAC is hand-picked for each meeting. They could bring in any 17 people they wanted. All they had to do was call Peter Hotez and tell him to bring 16 of his friends. So why did they skip this step?
From the NY Times:
The agency said that it did not convene its independent vaccine advisory committee because the panel had already had discussed the use of booster shots extensively and “the requests do not raise questions that would benefit from additional discussion.”
To be clear: the panel had already REJECTED the use of booster shots and the booster decision impacts hundreds of millions of Americans so that clearly merits considerable additional discussion. So the FDA is lying once again and we have to go looking for other explanations for their actions.
I’m wondering if the reason the FDA skipped the VRBPAC meeting this time is because they did not want to have to produce another risk-benefit analysis — given that the data showed no clinically significant benefit in preventing severe health outcomes? When the VRBPAC met in October to review Pfizer’s EUA application for children 5 to 11, the FDA’s risk-benefit analysis was widely ridiculed. The Pfizer application for kids showed no health benefits and considerable harms and so the FDA used preposterous tricks to claim benefits that do not exist. It was clear that the emperor has no clothes. Now that the FDA knows that the world is watching and everyone is onto their unethical statistical gimmicks, they could not bear further public scrutiny, so they just decided to skip that step altogether.
This was the “data” the FDA relied upon in making the “booster” decision:
For Moderna, regulators said, the data showed that 149 clinical trial participants who received a booster dose had higher antibody levels compared with 1,055 study volunteers who received only two doses. They said Pfizer’s data for 200 participants in a clinical trial showed the booster shot raised antibody levels compared to one month after a second shot.
Really? The Moderna treatment group had 149 participants in the treatment group and the Pfizer “clinical trial” had 200 “participants” (were the 200 participants divided between 3-dose treatment group and 2-dose “control”)? Is this a joke? There was no unvaccinated control group. Increases in antibodies tell us nothing about health impacts. They did not measure adverse events. These grotesquely undersized “trials” made no mention of preventing a single case of COVID (so presumably the mRNA shots produced no actual health impact or they would have mentioned it), no mention of absolute risk reduction in the population, and no mention of the Number Needed to Vaccinate to prevent a single hospitalization or death. No wonder the top two FDA vaccine regulators quit rather than approve this useless toxic junk.
My how the “Because Science™️” crowd has fallen! The FDA’s and CDC’s actions in approving these dangerous products in the absence of proper data is shameful and criminal. When we take power, all of their current leadership will face prosecution at the Nuremberg 2.0 trials.