FDA forces out top vaccine official

The Food and Drug Administration (FDA) has forced Dr. Peter Marks to resign as director of the Center for Biologics Evaluation and Research (CBER).

Marks played a key role in Operation Warp Speed, the first Trump administration’s initiative to develop the experimental mRNA shots. He was part of the team that rushed the authorization for the injections, which have cratered public trust in vaccines and public health officials. CBER, which Marks will leave on April 5th, is the FDA unit that oversees vaccines, gene therapies, and blood products.

According to the Wall Street Journal, Marks stepped down on Friday after he was told to resign or face termination. 

“If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy,” an official from the Department of Health and Human Services (HHS) said.

In a bitter resignation letter addressed to acting FDA Commissioner Sara Brenner, Marks accused HHS Secretary Robert F. Kennedy, Jr. of “misinformation.”

“It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” he wrote. “My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end,” he added.

The vaccine is causing myocarditis, but maybe it isn’t

In June 2022, Marks acknowledged a fivefold increase in myocarditis among vaccinated children 12-17 but downplayed the danger by suggesting the vaccine was not to blame. 

“[Myocarditis] is a known phenomena in the 12-17 year-old age range,” said the CBER director. “And the rate that it was seen in the 12-17 year-olds who are vaccinated seem to be fivefold higher than the baseline rate that we would expect. And that’s why this is not a slam dunk.” 

“Here, it’s very challenging. When something’s only three to five times more common in a vaccinated population, you don’t know whether it’s cases that would have been there, that aren’t really associated with the vaccine that have come up, or how much actually the vaccine has increased that risk,” he added.

Marks emphasized that he was not denying that the vaccine has a myocarditis safety signal, but he also tried to suggest that the jump in myocarditis was normal. 

“I’m not trying to deny that there’s some signal here. I’m just trying to say the magnitude of this over what we might be seeing is baseline, summertime, viral myocarditis is hard to know exactly. But just to give you an idea of the order of magnitude, we’re seeing about fivefold more than you might expect if this were normal summertime.”