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FDA Vaccine Regulator Vacates Role

March 10, 2026
Elisa Ma

Dr. Vinay Prasad of the Food and Drug Administration (FDA) is set to resign as the head of the vaccine regulatory center in April 2026. FDA Commissioner Dr. Marty Makary appointed Dr. Prasad in May 2025. Prior to that, Dr. Prasad was placed on a week-long leave of absence last July-August after Laura Loomer, a right-wing activist and influencer, clipped an audio depicting Dr. Prasad as anti-Trump. Dr. Prasad was reinstated into his role by Commissioner Makary, who just announced the agency will find a replacement.

Who is Dr. Vinay Prasad?

Dr. Vinayak “Vinay” Prasad serves as the Chief Medical and Scientific Officer for the Center for Biologics Evaluation and Research (CBER) at the FDA. The CBER is the primary regulatory entity for vaccines in the United States.

Dr. Prasad received his MD (Doctor of Medicine) from the University of Chicago Pritzker School of Medicine, completed residency at Northwestern University, and got his MPH (Master of Public Health) from the Johns Hopkins University Bloomberg School of Public Health.

Before working at the FDA, Dr. Prasad worked as a Professor in the Epidemiology and Biostatistics at the University of California, San Francisco (UCSF) School of Medicine.

Work at the FDA

Dr. Prasad has sparked controversy for striking down approvals, like Moderna’s application for an mRNA flu vaccine. His proposed, intensive regulatory framework for vaccines, alongside his vaccine distrust and public telling disagreers to resign, has also drawn criticism from twelve former FDA commissioners who served under Democratic and Republican presidencies.

In February, Commissioner Makary and Dr. Prasad changed regulation to only require one rigorous study for a new drug approval. In 2011, Dr. Prasad and Dr. Adam Seth Cifu from the University of Chicago published a book and paper titled Medical Reversal: Why We Must Raise the Bar Before Adopting New Technologies, warning how the lack of upfront clinical trials jeopardizes patient lives and trust.

Leaving the FDA

Commissioner Makary’s tweet regarding Dr. Prasad’s departure indicates he will be returning to UCSF after his one-year academic sabbatical.

However, his co-author, Dr. Cifu, recommended a Substack, indicating this resignation may not have been as voluntary or planned as it seems. Just days before the announcement of Dr. Prasad’s resignation, an “anonymous” (following the description of Dr. Prasad) FDA official answered how long they would stay at the FDA. The official said, “I would say that I serve at the pleasure of the [FDA] commissioner and the [health] secretary and the president, and as long as we’re all in alignment — that me serving is in the best interest of the American people — I will continue to serve happily”.

It is also important to note that the FDA and broader Department of Health and Human Services are experiencing a “revolving door” phenomenon, where government workers move to private sector jobs in the fields they once regulated, and vice versa. Health Secretary Robert F. Kennedy Jr. championed the move to “slam shut the revolving door”, but has also appointed key roles to people from industry.

Cracking down on the “revolving door” is difficult across government, but in healthcare and biotech, it is also the move federal workers are making for self-preservation. Scott Gottlieb, FDA Commissioner from 2017 to 2019, now a board member of Pfizer, estimated that proposed and actual layoffs and funding cuts have led to 600 FDA drug reviewers excusing themselves from cases because they are actively applying for industry jobs.

While Dr. Prasad has not remarked on his future endeavors, in 2016, he published findings about the “revolving door” at the FDA, where (albeit with a small sample size) 57% of ex-FDA reviewers ended up working for the pharmaceutical industry. In a discussion with NPR, he commented that this potential conflict of interest could influence regulator behavior, especially as the FDA is often the only way the public can know to trust new drugs.

What’s Next?

The FDA can find a replacement, and likely one who is also keen on fast-tracking approvals, per President Trump’s agenda. But for everyone impacted by public health, Dr. Prasad’s departure likely isn’t just about vaccine policy, but rather indicative of the broader politics of the FDA.