FDA vaccine chief pick: Hemmati emerges as front-runner

The race to lead the nation’s top vaccine division is narrowing.

Dr. Houman Hemmati has emerged as the leading candidate for the FDA vaccine chief pick, according to people familiar with the decision, as federal health officials weigh who will oversee one of the agency’s most scrutinized roles.

If selected, Hemmati would take over the Center for Biologics Evaluation and Research (CBER), the division within the U.S. Food and Drug Administration responsible for regulating vaccines and gene therapies.

The position is opening at a moment of turbulence.

Current director Dr. Vinay Prasad is set to leave the agency after facing criticism over several high-profile regulatory decisions, including delays or rejections tied to new therapies and vaccines.

His tenure also drew controversy following claims about Covid-19 vaccines that were not publicly substantiated.

Hemmati, an ophthalmologist by training, is not a traditional choice for the role. Much of his recent experience has been in biotech, including as co-founder and chief medical officer of Optigo Biotherapeutics.

He has also been a vocal critic of aspects of the government’s pandemic response—positions that could shape how he approaches the role if confirmed.

The final decision has not been made.

Officials at the Department of Health and Human Services and the White House are still reviewing “several” candidates, according to sources. A spokesperson for HHS said the agency continues to evaluate qualified contenders, while the White House cautioned that no personnel decision is official until formally announced.

Behind the scenes, the stakes are high.

The next leader of CBER will help define regulatory priorities for vaccines, gene therapies and emerging biotechnologies at a time when both industry and public trust are in flux.

Dr. Ofer Levy of Boston Children’s Hospital said the division needs stability after recent leadership turnover.

“I think we can all agree that there’s been some degree of instability,” he said, adding that clearer direction is needed for both researchers and pharmaceutical companies.

For now, Hemmati appears to be the frontrunner—but in Washington, until a decision is official, nothing is final.