FDA Vaccine Chief Resigns, Shares of Drugmakers Plummet

BENGALURU, India — Shares of U.S. drug manufacturers declined sharply on Monday following the resignation of the Food and Drug Administration‘s (FDA) top vaccine official, Dr. Peter Marks. His exit comes during a pivotal moment as the Trump administration initiates significant changes across federal health agencies.

The biotechnology sector faced added pressure amid concerns surrounding President Donald Trump’s newly proposed tariffs, which may now include pharmaceuticals, an area previously exempt. The announcement contributed to a drop in shares, with the S&P 500 biotech ETF plummeting 4.9%, compounding a roughly 6% decline this year.

Dr. Marks, who played a crucial role in the development of COVID-19 vaccines during Trump’s first term, will officially leave the FDA on April 5. His resignation was detailed in a letter, which noted his disapproval of the perspectives on vaccine safety from the new Secretary of Health and Human Services, Robert F. Kennedy Jr.

“It’s no secret that biotech has been under immense pressure recently given broader macro issues. This unfortunate update does nothing to reassure investors,” stated Evan Seigerman, an analyst at BMO Capital Markets.

In response to the news, major vaccine manufacturers such as Novavax and BioNTech saw their stock prices drop between 6% and 8%. Meanwhile, gene therapy companies were hit even harder: Taysha Gene Therapies plummeted 30%, Solid Biosciences fell 14%, and Sarepta Therapeutics decreased by 10%.

Kennedy, who has gained notoriety for his controversial views on vaccines, aims to restructure federal health agencies, potentially resulting in significant workforce reductions. Reports from Friday indicated that Marks was given an ultimatum to either resign or face termination from a Health and Human Services official.

Marks has publicly supported expedited development programs for rare diseases and gene therapies during his tenure. His departure comes shortly after the resignation of Patrizia Cavazzoni, head of the FDA’s drug evaluation unit.

“Given Dr. Marks’ influence on the development of biologics and uncertainty about his successor, his leaving will create a significant near-term overhang for the market,” observed William Blair analyst Matt Phipps.

Although HHS declined to comment on the situation, comments from Marks suggested deep discontent with the current administration’s approach. In his resignation letter, he remarked, “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.”

While the search for a replacement continues, analysts express concern that the new appointee may share Kennedy’s views, complicating the future of vaccine regulation and public health. The FDA and Trump administration representatives did not respond to requests for comments.