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Ophthalmologist Emerges as Frontrunner for FDA Vaccine Chief Role
Dr. Houman Hemmati, a critic of the government's COVID-19 vaccine response, is being considered to lead the FDA's vaccine division.
Apr. 14, 2026 at 5:27pm
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The selection of the next FDA vaccine chief will shape the future of medical regulation and public trust in the agency.Boston TodayAccording to two anonymous sources, Dr. Houman Hemmati, an ophthalmologist who has been critical of the government's COVID-19 vaccine response, is the frontrunner to replace Dr. Vinay Prasad as the director of the FDA's Center for Biologics Evaluation and Research (CBER), the division responsible for overseeing the safety and effectiveness of vaccines and gene therapies. While officials within the Department of Health and Human Services view Hemmati as the top choice, no final decision has been made, and the White House, HHS, and FDA are all involved in the selection process.
Why it matters
The CBER director plays a crucial role in regulating vaccines and other biologics in the United States. Hemmati's potential appointment has raised concerns, as he has been outspoken in his criticism of the government's COVID-19 vaccine policies, including accusing the Biden administration of buying more doses to help drugmakers 'recoup' their investment.
The details
Hemmati is the co-founder and chief medical officer of Optigo Biotherapeutics, a Canadian biotech company focused on addressing vision loss. He has held senior roles at other biotech companies as well and has made occasional appearances on Fox News, where he has criticized the government's pandemic response. The FDA's vaccine division has faced criticism and instability in recent years, with Prasad leaving the agency this month after facing backlash over delays or rejections of several treatments and vaccines.
- Prasad is leaving the FDA this month.
- A decision on the new CBER director is likely imminent.
The players
Dr. Houman Hemmati
An ophthalmologist and the co-founder and chief medical officer of Optigo Biotherapeutics, a Canadian biotech company focused on addressing vision loss. Hemmati has been critical of the government's COVID-19 vaccine response and is the frontrunner to replace Dr. Vinay Prasad as the director of the FDA's Center for Biologics Evaluation and Research (CBER).
Dr. Vinay Prasad
The outgoing director of the FDA's Center for Biologics Evaluation and Research (CBER), 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.
Dr. Marty Makary
The current FDA Commissioner, who is said to prefer Hemmati as the candidate for the CBER director role.
Dr. Ofer Levy
The director of the Precision Vaccines Program at Boston Children's Hospital, who stated that the vaccine division is in need of a strong leader.
What they’re saying
“I think we can all agree that there's been some degree of instability at the FDA and CBER. Academic centers, and importantly industry, need a clear signal about what the rules of the game are and what are the priorities.”
— Dr. Ofer Levy, Director of the Precision Vaccines Program at Boston Children's Hospital
What’s next
The White House, the Department of Health and Human Services, and the FDA are all closely involved in the decision-making process for the new CBER director. A final decision is expected to be announced in the near future.
The takeaway
The selection of the next CBER director will have significant implications for the regulation of vaccines and other biologics in the United States, particularly given Hemmati's past criticism of the government's COVID-19 vaccine policies. The decision will be closely watched by the medical and scientific community, as well as the public, as the FDA seeks to restore stability and confidence in its vaccine division.
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