FDA Defends Approval of New Boosters Without Human Trials

FDA Defends Approval of New Boosters Without Human Trials
Food and Drug Administration (FDA) signage is seen through a bus stop at the U.S. Department of Health and Human Services, in Silver Spring, Md., on Thursday, Aug. 2, 2018. (Jacquelyn Martin/AP)

The leadership of the U.S. Food and Drug Administration is defending its approvals of new booster vaccines for COVID-19 without completed human trials.

“This is a type of vaccine that has now been given to billions of people and we have a good understanding of how it works, so it’s not like something just coming out of the hopper with just animal studies,” FDA Commissioner Robert Califf said on Aug. 31 during a virtual press conference on the authorization of the new boosters.

He said he took “exception” to a suggestion that “only animal studies” were used to evaluate the safety and efficacy of the vaccines.

The announcement of the FDA’s approval of the new boosters from Moderna and Pfizer/BioNTech follows several news reports that the boosters would be authorized by the FDA without testing on human subjects completed, with the FDA relying in part on trials using mice.

Dr. Peter Marks, the FDA’s top vaccine expert, insisted that the agency knows how the mRNA vaccines work and can use the data it has from other boosters to “predict how well the vaccine will be working.”

The new boosters will target the original COVID-19 virus and will also target the newest subvariants of the omicron strain known as BA.4 and BA.5.

“It is matched to what is currently circulating,” said Marks, “and the hope here is that by increasing the amount of antibodies that we have to that particular variant we will restore the kind of protection that we had when we first saw these vaccines launched in the late part of 2020, early part of 2021, when we had very good protection against symptomatic disease.”

He added that the FDA doesn’t “know for a fact” whether the new boosters will afford this level of protection, but says it’s the agency’s goal.

“Obviously we’ll be conducting vaccine surveillance to see how closely we’ve gotten to this,” he added.

Califf said the FDA simply could not wait for human trials to be completed.

“We have to be a step ahead, or at least we have to try to be a step ahead, because if we waited for all the proof to come in the wave will have already passed us by and the damage will have already been done,” he said.

“It’s fair for people to raise questions, but this really is the best consensus that we have among the experts that this is the best way to go. And in particular, watching, it’s just painful to see people dying unnecessarily when there’s a free treatment that would prevent their deaths.”

The FDA is authorizing the new Moderna booster for people age 18 and up, and the Pfizer booster for people age 12 and up.

It’s recommending people get them at least two months following either a primary dose of the vaccine or a booster.

But the agency is facing headwinds in its campaign to encourage continued vaccination for COVID-19, as less than half of Americans have gotten a booster after getting a primary dose of one of the vaccines.

It also appears to be losing ground in the battle over information, with an increasing number of physicians and researchers warning that a vast amount of data shows that the vaccines may be doing more harm than good.

One of them is Dr. Dan Stock, a family practice doctor in Indiana and a member of the Global Covid Summit Group.

“The FDA has been ignoring all the signals of harm,“ he said. ”And one of the reasons they do that is they say it’s the CDC’s job to do VAERS.  And the CDC has even greater financial conflicts of interest, and so they bacically screw things up even worse.”

VAERS, the Vaccine Adverse Event Reporting System, shows more than 30,000 deaths following vaccination with one of the COVID-19 vaccines, and more than 1 million reported adverse events, with adverse event being defined as a possible side effect.

The VAERS system is operated jointly by the FDA and CDC. Anyone, including healthcare providers, patients and family members, can submit a report to the VAERS system. VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.

The VAERS data showing the extraordinarily high number of deaths and possible side effects related to the COVID-19 vaccines was not mentioned in the Aug. 31 virtual FDA press conference, and it’s unknown what vaccine surveillance will be conducted by the FDA to monitor the safety of the new vaccines.

The only results of safety monitoring on the FDA’s website appear to be from July 12, 2021, when the FDA announced that real-time surveillance of Medicare claims for people 65 and up showed four potential side effects of the Pfizer-BioNTech vaccine: pulmonary embolism (blood clot in the lung), acute myocardial infarction (heart attack), immune thrombocytopenia (low platelet levels that can lead to excessive bleeding) and disseminated intravascular coagulation (abnormal blood clotting).

The new boosters constitute the fourth dose of the Moderna and Pfizer vaccines, and are aimed to address the latest variant, omicron.

But how many more variants could there be? How does this end?

“For multiple reasons, it will never end,” says Stock. “The virus was going to always mutate from the day it got out of that lab, because that virus mutates.”

Dr. Pierry Kory, one of the founders of the Front Line COVID-19 Critical Care Alliance and the former head of critical care for the University of Wisconsin hospital, told The Epoch Times on Aug. 29 that the omicron variant is no more lethal than the common cold.

“You’re vaccinating against a cold,” he said, calling the FDA’s authorization of the new boosters an “absurdity.”

“To even pretend there’s a rationale… It leaves me speechless,” he said.