In a long-anticipated reckoning at the U.S. Food and Drug Administration (FDA), Dr. Peter Marks, the embattled vaccine chief who oversaw the COVID-19 rollout, was ousted following pressure from Health and Human Services Secretary Robert F. Kennedy Jr.
Marks, who led the FDA’s Center for Biologics Evaluation and Research (CBER) for nearly a decade, submitted his resignation on March 28 following weeks of internal conflict with Kennedy, whose push for transparency and accountability within federal health agencies has rattled the pharmaceutical establishment.
“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 HHS spokesperson told NBC News.
Marks’ resignation, effective April 5, comes at a pivotal time as Kennedy seeks to overhaul the FDA’s vaccine safety protocols and address longstanding allegations of regulatory capture. In a letter to Acting FDA Commissioner Dr. Sara Brenner, Marks said he was “willing to work” with Kennedy to address concerns about vaccine safety—but ultimately deemed the working relationship untenable.
“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, according to a copy of the letter obtained by the Associated Press.
According to a former FDA official familiar with the matter, Marks was given a choice: resign or be fired.
Dr. Marks played a key role in granting Emergency Use Authorization for COVID-19 vaccines despite limited long-term safety data. Under his leadership, CBER downplayed early safety signals and failed to act on a growing body of evidence pointing to serious adverse events, including myocarditis, blood clotting disorders, and neurological complications.
During multiple public hearings and press events, Marks repeatedly assured the public that the benefits of COVID-19 vaccines “far outweigh the risks,” even as reports of post-vaccine injuries mounted in the Vaccine Adverse Event Reporting System and other safety databases.
In an effort to protect the shots at all costs, Marks routinely dismissed or ignored data that conflicted with the administration’s narrative and resisted calls for independent safety reviews. In 2022, for example, his office opted not to convene an external advisory committee before authorizing updated COVID-19 booster shots—a move that drew backlash from both scientists and watchdog groups.
“Peter Marks has been a key enabler of one of the most misleading public health campaigns in modern history,” said a senior HHS official who requested anonymity. “Under his leadership, the FDA became a rubber stamp for industry rather than a guardian of public health.”
Industry Turmoil and Investor Fallout
The announcement of Mark’s resignation triggered immediate turmoil on Wall Street. Biotech stocks, particularly those tied to gene therapies and vaccine development, tumbled sharply on Monday. Shares of Moderna, Beam Therapeutics, and Sarepta Therapeutics all posted significant losses, with investors spooked by what some see as a seismic shift in regulatory posture under Kennedy.
The Biotechnology Innovation Organization (BIO), the industry’s largest lobbying group, issued a rare rebuke, warning that Marks’ departure could “erode scientific standards” and undermine confidence in FDA decision-making. Meanwhile, analysts at Cantor Fitzgerald urged the administration to reconsider Kennedy’s position, calling his influence “dangerously disruptive.”
But Kennedy’s supporters argue that a reckoning is long overdue.
“For too long, federal health agencies have operated with zero accountability, enabled by people like Peter Marks,” said Mary Holland, president of Children’s Health Defense. “This resignation is just the beginning of cleaning house.”
More Changes Ahead
Marks is the third high-ranking official to depart the FDA in 2025, following the exits of Dr. Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research, and Jim Jones, head of the agency’s food division. The string of resignations reflects deepening fractures within the agency and signals that more upheaval may lie ahead.
Kennedy has not publicly commented on Marks’ exit, but insiders say the Secretary is expected to announce additional personnel changes in the coming weeks as part of his sweeping reform agenda.
With Marks out, questions remain about who will fill the leadership vacuum at CBER—and whether the agency can regain public trust after years of controversy surrounding its disastrous handling of COVID-19 vaccines.
