29 Mar 2025

Top vaccine official forced out of US FDA

7:44 pm on 29 March 2025

By Nora Gaul, John Bonifield and Meg Tirrell, for CNN

Dr Peter Marks, US director of the Centre for Biologics Evaluation and Research at the Food and Drug Administration (FDA), testifies during a Senate committee hearing on the on-going response to Covid-19,  at the US Capitol, on 11 May, 2021.

Dr Peter Marks was reportedly forced to resign from his position as a US public health leader, as head of the Centre for Biologics Evaluation and Research at the Food and Drug Administration (FDA) (shown during a Senate committee hearing into the Covid-19 response, in 2021). Photo: AFP/ pool - Jim Lo Scalzo

The head of the US Food and Drug Administration department responsible for assuring the safety and effectiveness of vaccines has resigned, according to a resignation letter obtained by CNN.

Dr Peter Marks, director of the FDA's Centre for Biologics Evaluation and Research, was given the choice to resign or be fired. Marks' resignation takes effect 5 April.

The news of Marks' forced resignation was first reported Friday by The Wall Street Journal.

"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," Marks wrote in his letter, referring to US Health and Human Services (HHS) Secretary Robert F Kennedy Jr.

In an email, an HHS official told CNN, "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."

FDA's Centre for Biologics Evaluation and Research is responsible for the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue and gene therapies.

Independent presidential candidate Robert F. Kennedy Jr. speaks at the Libertarian National Convention on May 24, 2024 in Washington, DC.

Robert F. Kennedy Jr. Photo: Kevin Dietsch / Getty Images / AFP

Marks was instrumental in carrying out Operation Warp Speed, the federal government's Covid-19 vaccine development program. He has overseen the approval of more recent vaccines, including the first influenza vaccine for self- or caregiver-administration, providing a new option for protection against seasonal flu.

Marks' forced resignation and other recent moves by HHS drew a wave of warnings from health experts.

"This is what happens when you hire a 20 year virulent anti-vaccine activist who continues to deny the science that vaccines don't cause autism, and put him in a position of influence," Dr Paul Offit, director of the Vaccine Education Centre at Children's Hospital of Philadelphia and a vaccine adviser to the FDA, told CNN, referring to Kennedy.

"So what you're about to see is studies done, presumably under the imprimatur of the CDC, showing that vaccines cause autism. That's what you're about to see, because he will put in place people who will shoehorn data to make it look that way, which will create more fear, will create likely more people who will choose not to be vaccinated, and you'll just see more and more in the way of these outbreaks."

Earlier in March, HHS asked the CDC to study vaccines and autism, despite strong evidence that vaccines do not cause autism.

Dr Ashish Jha, dean of the Brown University School of Public Health and Covid-19 response coordinator during the Biden administration, said on X that Marks is a brilliant scientist who "helped usher in scientific rigor and transparency into the FDA."

Pushing him out makes "the FDA dramatically weaker, less effective," Jha wrote. "This is not how we make America healthy."

- CNN

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