FDA’s top vaccine chief Peter Marks is out the door!
Amid vaccine safety disputes and looming legal challenges, the agency's vaccine chief Peter Marks exits under intense pressure.
The US Food and Drug Administration’s (FDA) top vaccine regulator, Peter Marks, has abruptly resigned from his post as director of the Center for Biologics Evaluation and Research (CBER), reportedly having been “forced out.”
In his resignation letter, Marks made it clear that he did not leave willingly. He blamed the newly minted Health Secretary, Robert F. Kennedy Jr, for his exit.
“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. He also warned of an “unprecedented assault on scientific truth.”
So what actually happened?
I don’t have inside knowledge of the exact circumstances, but it’s evident there was a significant clash over vaccine safety.
Marks specifically mentioned that vaccines do not cause autism, taking aim at Kennedy’s push for further investigation into the safety of the MMR vaccine.
“Though rarely followed by a single fever-related seizure, or very rarely by allergic reactions or blood clotting disorders, the vaccine very simply does not cause autism, nor is it associated with encephalitis or death,” Marks asserted in his letter.
Marks' troubled legacy at the FDA
Frankly, I don’t see Marks’ resignation as a loss for the agency. If anything, it may be an opportunity for the FDA to refocus on its mission of protecting public health rather than rubber-stamping new vaccine approvals.
Throughout the Covid-19 pandemic, Marks proved himself to be an unwavering champion of Operation Warp Speed—a project that fast-tracked vaccine trials, cut corners on safety testing, and bypassed essential trial site and manufacturing inspections.
Despite mounting evidence of mRNA vaccine-related harms, Marks remained steadfast in dismissing these concerns as “misinformation.”
He repeatedly pointed to the Vaccine Adverse Event Reporting System (VAERS) as proof of rigorous safety monitoring, yet failed to improve its efficiency.
He authorised Covid-19 mRNA vaccines for young people without testing for meaningful clinical outcomes—basing the decision on immunobridging data of antibody titres, which even he admitted was a poor correlate of protection against Covid.
Marks also blurred the line between regulation and promotion, featuring in FDA videos advocating for vaccines—an act far outside the agency’s regulatory remit.
Internal power struggles at the FDA
Marks’ departure also brings to mind his history of internal clashes at the FDA. He had a tense relationship with Dr. Marion Gruber, who led the Office of Vaccines Research and Review (OVRR).
Gruber and her deputy, Dr. Philip Krause, resisted pressure to license Pfizer’s Covid mRNA vaccine, saying they felt pressured by the “hyper-accelerated” timeline and feared it would backfire.
In July 2021, Gruber raised concerns with then-FDA Commissioner Janet Woodcock about being pushed to accelerate the process to accommodate the Biden administration’s vaccine mandate agenda.
In a Freedom of Information Act (FOIA) release, Marks expressed his frustration to Woodcock, criticising Gruber’s reluctance to compress the already tight deadlines.
“The lack of urgency and responsiveness to the public health imperative to save lives that seems to be felt by some in leadership of the Office of Vaccines [referring to Gruber here] is highly disappointing to me,” Marks wrote in his email.
Then, when Gruber planned to be out of the office temporarily, she expected her deputy to assume the acting role in her absence, as was standard protocol. Instead, Woodcock overrode this and put Marks in charge. Gruber was furious.
Soon after, Gruber and Krause resigned.
The Citizen Petition that cannot be ignored
Marks’ sudden exit may also be tied to a growing legal challenge against the FDA—one that could have become a major issue for him had he remained in his role, but will now fall to his colleagues to handle.
A Citizen Petition filed on 20 January 2025 calls for the outright revocation of the Pfizer and Moderna Covid-19 vaccines, arguing that the FDA violated regulatory steps by failing to classify them as “gene therapies.”
The FDA is accused of “wrongfully and illegally” permitting Pfizer and Moderna to bypass the required Environmental Assessments (EAs) under 21 CFR Part 25—a crucial regulatory step for biologics.
If the FDA acknowledges that mRNA vaccines are indeed gene therapies, as the petition contends, the agency could face serious legal and regulatory repercussions.
Marks, who has decades of expertise in gene therapy development, has been one of the strongest proponents of mRNA technology—despite widespread concerns that it was an immature platform rushed into global deployment.
Will the revolving door spin again?
While Marks’ departure may seem like a dramatic shake-up, history suggests he won’t be out of work for long.
The pharmaceutical industry has long served as a cushy landing pad for former regulators. Given the revolving door between the FDA and Big Pharma, it’s highly likely he will soon take a well-paid position at a biotech or pharmaceutical firm.
During his 2023 presidential campaign, Kennedy told me he wanted to fix this very issue.
“We will institute new rules extending the waiting period before former officials can enter industry, consulting, and lobbying. We want real public servants in positions of public trust,” Kennedy told me at the time.
Now, as Health Secretary, Kennedy may have the chance to follow through.
Peter Marks’ resignation letter:
i cannot refrain from commenting
.. Peter Marks is a despicable human being who exemplified wilful blindness and unquestioning allegiance to his pharmaceutical overlords
news of his departure earlier today lifted one of the great Covid weights from me
at least he had enough intelligence to jump before being pushed for his misinformation and lies
.. but we are waiting for him .. in the water
The use of the word "misinformation", particularly by a health professional, is the last refuge of a scoundrel.
Similar to the smears "antivaxxer", "fascist", et al.
A secondary school science student should understand that science is a process and not a consensus.
Marks parked his scientific acumen at the front door and deserves opprobrium for his ill-informed views.