Top FDA Vaccine Official Removed Under Trump Amid Conservative Backlash

Leadership Changes at the FDA

Vinay Prasad, a prominent critic of widespread coronavirus vaccination efforts and former head of the Food and Drug Administration’s (FDA) vaccine and gene therapy division, was recently removed from his position. According to two sources familiar with the situation, Prasad was ousted in late May. The decision comes amid growing controversy over his leadership and decisions related to drug approvals.

Prasad had faced criticism from various quarters, including some Republicans and conservative activists. Notably, far-right activist Laura Loomer accused him of being “The Progressive Leftist Saboteur Undermining President Trump’s FDA.” She also claimed he was “anti-Trump,” further fueling the political tension surrounding his role at the agency.

The FDA division Prasad led is responsible for overseeing biological medical products, including treatments for rare diseases. This division has been under scrutiny following reports of patient deaths linked to a drug made by Sarepta Therapeutics, which treats Duchenne muscular dystrophy. The controversy around this drug and its approval process added to the pressure on Prasad during his tenure.

Despite the lack of official explanation for his departure, the Department of Health and Human Services (HHS) confirmed that Prasad left his position. A statement from HHS spokesperson Andrew Nixon said, “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family.” He added that the agency thanks Prasad for his service and the reforms he implemented.

Prasad, who previously served as a professor at the University of California, San Francisco, and an epidemiologist, did not immediately respond to requests for comment. However, his career has been marked by a critical stance toward the regulatory processes used to approve medications, particularly cancer drugs. His research has highlighted concerns about the use of surrogate endpoints—early indicators of drug effectiveness—that may not necessarily translate into longer life expectancy.

His removal coincided with a shift in the FDA's approach to certain therapies. For instance, the agency lifted a hold on shipments of Sarepta’s gene therapy for Duchenne muscular dystrophy after three potential deaths were linked to the treatment. The decision allowed patients who are still able to walk to continue receiving the therapy.

The ouster of Prasad has sparked reactions from Wall Street analysts, who believe it could benefit companies like Sarepta that develop cell and gene therapies. These firms often seek accelerated approval through pathways that Prasad had previously criticized.

Before joining the Trump administration, Prasad gained recognition for his critiques of the public health response to the pandemic, including vaccine mandates and annual vaccinations for children. In May 2023, he replaced Peter Marks, who had been instrumental in promoting coronavirus vaccines, as the head of the FDA’s Center for Biologics Evaluation and Research.

Marks was forced out in late March by Health and Human Services Secretary Robert F. Kennedy Jr. Prasad was later appointed as the FDA’s chief medical and scientific officer, giving him a broad role within the agency. He frequently appeared on a new FDA podcast launched by Commissioner Marty Makary, whom Prasad had supported as a strong leader for the agency.

Together, Prasad and Makary developed a framework for updating coronavirus vaccines, focusing on adults 65 and older and those at high risk for severe disease. Makary has publicly defended Prasad, stating in an interview with Politico, “There’s not a political bone to his body. He’s an impeccable scientist, I think one of the greatest scientific minds of our generation.”

As the FDA continues to navigate complex regulatory challenges, the departure of Prasad marks a significant shift in leadership and policy direction.