Dr. Houman Hemmati, an ophthalmologist critical of the government’s Covid vaccine response, is the front-runner for the role of the nation’s vaccine chief at the Food and Drug Administration, according to two people familiar with the matter.
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If selected, Hemmati would replace Dr. Vinay Prasad, who is leaving the agency this month after facing criticism over the FDA’s delay or rejection of several treatments and vaccines, including a gene therapy for Duchenne muscular dystrophy, a rare blood cancer treatment and Moderna’s mRNA flu vaccine. Prasad was also the author of a controversial memo claiming the Covid vaccines killed at least 10 children; evidence backing the claim was never released.
The director of the FDA’s Center for Biologics Evaluation and Research (CBER) leads the division responsible for ensuring the safety and effectiveness of vaccines and gene therapies.
A decision on who will lead CBER is likely imminent, the people said, speaking on the condition of anonymity because they were not authorized to speak publicly.
Hemmati is said to be FDA Commissioner Marty Makary’s preferred candidate, one of the people said. “Several” candidates are under consideration, the other person said. The White House, the Department of Health and Human Services, and the FDA are all closely involved in the decision.
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Although officials within HHS view Hemmati as the topic choice, no decision has been made, and it’s possible the administration could go with other candidates, the people said.
Endpoints News was the first to report that Hemmati is under consideration. Hemmati did not respond to a request for comment.
In a statement, Andrew Nixon, a spokesperson for HHS, which oversees the FDA, said: “No decision has been made on the selection of the next CBER director. We continue to vet highly qualified candidates.”
White House spokesperson Kush Desai said in a statement, “Any reporting about personnel decisions, unless officially announced by the White House, should be considered baseless speculation.”
According to his LinkedIn, Hemmati is the co-founder and chief medical officer of Optigo Biotherapeutics, a Canada-based biotech company that aims to address vision loss and has held senior roles at other biotech companies focused on eye care. He makes occasional appearances on Fox News.
Like Makary before becoming FDA chief, Hemmati has been critical of the government’s response to the Covid pandemic.
In a 2023 Fox News appearance, Hemmati criticized the Biden administration’s decision to purchase additional Covid shots, accusing the government of buying more doses to help drugmakers “recoup” their investment.
In a post last May on X, Hemmati praised Makary and Prasad’s decision to end broad support for Covid vaccines for healthy kids and pregnant women.
Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital, said the vaccine division is in need of a strong leader.
“I think we can all agree that there’s been some degree of instability at the FDA and CBER,” Levy said. “Academic centers, and importantly industry, need a clear signal about what the rules of the game are and what are the priorities.”