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Dr. Vinay Prasad is returning to his job as the U.S. Food and Drug Administration’s (FDA) top vaccine regulator, less than two weeks after stepping down amid pressure from vocal critics.
Prasad will lead the Center for Biologics Evaluation and Research (CBER) at the FDA’s request, the U.S. Department of Health and Human Services (HHS) confirmed Saturday.
“Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration,” HHS Communications Director Andrew Nixon said in a statement to The Defender.
Prasad’s rehiring in the face of stark criticism suggests that U.S. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary remain influential in the White House, The New York Times reported. Kennedy and Makary defended Prasad against mounting attacks in the days before his resignation.
Makary told reporters Aug. 4 that he was working to persuade Prasad to return to the agency.
Prasad did not comment publicly on his resignation, but a spokesperson said, “Prasad did not want to be a distraction” to the FDA or the Trump administration.
Prasad resigned on July 29, amid controversy over his decision to pull Elevidys, a profitable gene therapy for Duchenne muscular dystrophy, from the market following the deaths of three clinical trial participants. The drug is made by Sarepta Therapeutics.
On July 18, FDA leadership met with Sarepta, instructed the company to halt all clinical trials and asked it to voluntarily stop all shipments. The company initially refused to halt shipments, according to the FDA, but eventually stopped shipping Elevidys on July 22.
The move provoked editorials from Allysia Finley at The Wall Street Journal, Bob Goldberg at Real Clear Health and STAT News, which all denounced Prasad for pausing distribution of the drug.
The STAT News piece was authored by two mothers — Jennifer Handt, who founded Charlie’s Cure, and Kelly Maynard, who started the Little Hercules Foundation — investigative journalist Paul D. Thacker reported.
“Sarepta funds Little Hercules and Charlie’s Cure seems quite cozy with the company,” Thacker said.
On July 28, the FDA ended the temporary hold on Elevidys, allowing Sarepta to resume shipments for patients who can walk.
It is unclear whether Prasad’s return will affect that decision.
Shares in biotech firms soared when Prasad’s departure was announced. They tumbled at the news of his return, Bloomberg reported.
Loomer vows to ‘ramp up’ her pressure campaign
In July, various influential voices critical of Prasad encouraged President Donald Trump to oust him.
Right-wing social media personality Laura Loomer called Prasad a “progressive leftist saboteur,” said his appointment was a “catastrophic vetting failure” within the Trump administration, and called for him to be fired.
Several lawmakers also reached out to Trump, urging him to remove Prasad.
In an Aug. 9 post on X, Loomer called Prasad’s return “another egregious personnel decision.” Vowing to “ramp up” her pressure campaign, Loomer wrote:
“In the coming weeks, I will be ramping up my exposés of officials within HHS and FDA so the American people can see more of the pay for play rot themselves and how rabid Trump haters continue to be hired in the Trump administration.
“There are several Senate Confirmation hearings coming up and I have multiple oppo books ready for distribution! Should be a good time.”
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Prasad known for ‘contrarian’ views
In May, Prasad replaced Peter Marks, M.D., Ph.D., as head of CBER. Marks, who oversaw Operation Warp Speed and the rapid development and approval of the COVID-19 vaccines, resigned in March under pressure from Kennedy.
Before his time at the FDA, Prasad was a professor of epidemiology and biostatistics at the University of California, San Francisco, where he was outspoken on social media outlets, including YouTube, Substack and X, about his views on scientific research and public health policies.
Mainstream media outlets, including The Associated Press and The Seattle Times, referred to his views as “contrarian.”
During the COVID-19 pandemic, Prasad publicly opposed masking toddlers and voiced concerns about myocarditis risks for young men who received mRNA COVID-19 vaccines.
While at the FDA, he and Makary limited approvals for updated COVID-19 vaccines to people over age 65 and people with one or more health conditions that put them at high risk for the virus.
However, Prasad and Makary’s framework, which they outlined in an article published in the New England Journal of Medicine, did not completely take COVID-19 shots off the table for healthy people between the ages of 6 months and 64 years.
Instead, it required vaccine makers to conduct randomized clinical trials that have clinical outcomes — preventing symptomatic COVID-19, hospitalization or death — on the drugs before the FDA would sign off on the vaccines.
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