Top US vaccine official Vinay Prasad leaves agency 3 months after being appointed

India Today

20 hours ago

The US Food and Drug Administration's (FDA) top vaccine official, Vinay Prasad, has left the agency after just three months as Director of the Centre for Biologics Evaluation and Research, a government spokesperson said.Prasad, an oncologist who was a fierce critic of the US COVID-19 vaccine and mask mandates, was appointed in May by FDA Commissioner Marty Makary. Together they promised to speed regulatory action and pilot new review pathways.advertisementIn recent days, criticism of Prasad's tenure has intensified around the agency's handling of a gene therapy for Duchenne muscular dystrophy from Sarepta Therapeutics.
The FDA-approved therapy played a role in the death of two teens who had advanced disease, and after a third death in a separate experimental gene therapy from the company, the FDA on July 18 asked Sarepta to stop all shipments of the approved DMD therapy, saying it had safety concerns.Laura Loomer, a far-right activist and President Donald Trump ally, on July 20 posted a blog in which she called Prasad a "progressive leftist saboteur" who was undermining the agency's work. Loomer's critiques earlier this year led to the ouster of national security officials.On Monday, the Wall Street Journal's opinion section ran two pieces criticising Prasad, one of which called him a Bernie Sanders acolyte in MAHA drag, referring to the Trump administration's "Make America Healthy Again" movement. Both said he was not basing regulatory decisions on whether drugs helped patients, but on price."When he saw some of these sort of smear pieces, he didn't want to be a distraction," Makary said of Prasad's departure in an interview with CNBC on Wednesday.George Tidmarsh, a former pharmaceutical executive who was recently appointed to lead the FDA's Center for Drug Evaluation and Research (CBER), will also be the acting CBER director, according to the agency's website.The Department of Health and Human Services, which oversees the FDA, did not announce when the role would be permanently filled.Prasad, whose departure was announced late on Tuesday, did not immediately respond to a request for comment.The FDA on Monday changed course on Sarepta and said shipments to the main group of patients for the drug could restart.Other changes under Prasad, who was also the agency's chief medical and science officer, included a new policy limiting the approval of COVID-19 vaccines, and his FDA division also rejected therapies from Replimmune and Capricor Therapeutics.Shares of Replimmune nearly doubled in value, while those of Sarepta and Capricor gained 11% and 18%, respectively, on Wednesday.Endpoints and STAT news first reported Prasad's departure.Prasad was a physician who joined the agency from the University of California, San Francisco. He has had stints at the National Cancer Institute and the National Institutes of Health.advertisementThe FDA and other health agencies have seen multiple shakeups in recent months, under the leadership of US Health Secretary Robert F. Kennedy Jr.Prasad's predecessor and long-time vaccine official at the FDA, Peter Marks, was ousted earlier this year, followed by gene therapy head Nicole Verdun."While another vacancy and another potential new face add uncertainty, we still think Prasad's departure is a net positive for the sector as many of our conversations have been overwhelmingly focused on regulatory risk and what he may or may not do," said Leerink analyst Joseph Schwartz.- EndsMust Watch
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