The US Food and Drug Administration is facing a major leadership shake-up, as its polarising top vaccine official, Dr Vinay Prasad, is once again leaving the agency. This marks the second time in less than a year that the Indian-origin researcher has parted ways with the agency’s division that approves vaccines and biotech drugs. The latest development indicates that Prasad will depart at the end of April 2026, according to FDA Commissioner Dr Marty Makary’s social media confirmation.
“A year ago, Dr. Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified covid vaccine framework, & the new plausible mechanism framework for ultra rare diseases which we launched last week,” Dr Makary wrote on X on Friday (US time). “Under his leadership, his center hit a record number of approvals in Dec. He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month.”
As opposed to his previous brief exit from the FDA, Prasad’s resignation hasn’t been fuelled by any bitter terms this time. Much like his admission in the recent tweet, Makary said in an interview that the American health researcher had always intended to remain at the agency as long as his one-year leave of absence from the University of California, San Francisco, the Wall Street Journal reported.
With Prasad heading back to his academic job, Makary affirmed that his replacement would be announced before he leaves in April.
Who is Dr Vinay Prasad?
According to the Wall Street Journal, Prasad is a podcaster and an academic who gained notoriety during the Covid-19 pandemic for opposing online the way public-health officials handled Covid-19 vaccines and other health policies. He studied drug pricing and critically called out the FDA for approving too many drugs that did little to help increase cancer patient’s lives.
A year ago, Dr. Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified covid vaccine framework, & the new plausible mechanism framework for ultra rare diseases which we launched last week.…
— Dr. Marty Makary (@DrMakaryFDA) March 6, 2026
He took over as the leader of the FDA’s vaccines and biotech drugs division after Dr Peter Marks resigned in March 2025 after being offered the choice to resign or be fired by a Health and Human Services (HHS) department official.
Prior to taking on his post at FDA, Prasad was a professor of epidemiology and biostatistics and medicine at UCSF. He has previously also worked at the National Cancer Institute and National Institutes of Health. Moreover, some may also recognise him as the author o the books “Ending Medical Reversal” and “Malignant.”
He even “ran the VKPrasad lab (www.vkprasadlab.com) at OHSU and UCSF (2015-2025), which studied cancer drugs, health policy, clinical trials and better decision making,” according to his LinkedIn profile.
As per a 2017 profile by OregonLive.com, Prasad’s parents immigrated from India to the US. He was eventually raised along with his younger brother in a suburb of Cleveland and then in northern Indiana. In 2005, he graduated summa cum laude from Michigan State University with a double major in philosophy and physiology.
Down the line, he ended up becoming a doctor “almost by accident,” as his college roommate, an aspiring physician, encouraged him to take the medical school entrance exam. After doing so and excelling at it, Prasad went to medical school at the University of Chicago following his graduation from Michigan State University with a Bachelor of Science in Physiology and Philosophy.
FDA’s vaccines chief Vinay Prasad’s controversies explored
Having been a longtime critic of the FDA’s standards for drug reviews, Prasad’s name has been embroiled in a web of high-profile controversies. In July 2025, the director of the FDA’s Center for Biologics Evaluation and Research (CBER) was briefly forced to step away from his job on a bitter note.
At the time, Prasad abruply resigned after less than three months in his position, claiming that he did not want to “become a distraction to the important work of the FDA under the Trump administration.” Back then, his exit was fuelled by political backlash and a high-profile dispute with Sarepta Therapeutics over the gene therapy delandistrogene moxeparvovec (Elevidys; Sarepta Therapeutics) for Duchenne muscular dystrophy (DMD), according to Contagion.
He ultimately returned to his role in August 2025, just two weeks after resigning. This decision was put into a motion at the request of the FDA and with the support of Health Secretary Robert F Kennedy Jr following a White House review of the political backlash targeting him.
Far-right influencer Laura Loomer especially led the charge against him at the time, as she highlighted Prasad’s old statements about US President Donald Trump and his praise for progressive US Senator Bernie Sanders.
Over the past few months, he also came under fire from pharmaceutical executives, investors and members of Congress for his decisions at the agency. He previously refused to allow the FDA to review a much-anticipated flu vaccine from drugmaker Moderna made with mRNA technology. The unexpected development prompted the company to publicly out Prasad’s decision and assert its commitment to formally challenging it.
A week after Prasad’s rejection made headlines, the FDA retracted its decision and said it would accept the vaccine for review, pending a study from Moderna. Prasad and Makary have repeatedly announced measures to facilitate faster drug reviews for companies. Contradicting his own ways, he often end up imposing new warnings and study requirements for some vaccines, especially Covid-19 shots.