FDA’s Vaccine Head Adds New Chief Medical, Science Officer Roles

Vinay Prasad, the FDA’s freshly appointed head of vaccines, has been named chief medical and scientific officer, taking on two additional roles that will make the vocal critic of past agency practices a top adviser to Commissioner Marty Makary.

“He will provide strategic input and leadership on trans-center working groups and initiatives, ensuring scientific consistency and integration across FDA centers and build partnerships with academic, governmental, and industry stakeholders,” Makary said Wednesday in an internal email obtained by Bloomberg Law that was sent to Food and Drug Administration staff.

“Dr. Prasad will also provide senior medical and scientific input to me on cross-center medical policy and regulatory decisions, and he will act as a senior medical and scientific representative at national, international, or advisory committee meetings and forums related to public health, regulatory science, and innovation,” Makary said.

The commissioner in May named Prasad as the head of the Center for Biologics Evaluation and Research.

The hematologist-oncologist, frequent YouTuber, and podcast host carries a public record of critical opinions on topics including mRNA and Covid-19 vaccines, clinical trial practices, and his predecessor at the FDA, Peter Marks.

Since taking on the role of CBER director, which oversees the safety and efficacy of vaccines, complex gene therapies, and the blood supply, Prasad has already introduced major policy changes and shared more details on his vision for the agency.

This includes the introduction of new testing requirements for vaccine manufacturers, which came with a decision that the FDA will no longer approve Covid booster shots for healthy adults and children without new trials. The move is expected to curtail access to Covid vaccines for healthy people under 65.

Prasad also participated earlier this month in an agency roundtable with experts on cell and gene therapy, and he’s been a voice in the agency’s new conversation platform, FDA Direct.

“In the roughly one month since Dr. Prasad joined the FDA as head of CBER, he has played a key role in advising me and helping advance the FDA’s work in several priority areas,” Makary said.

“Dr. Prasad’s range of creative ideas and intellect are surpassed only by his energy. I am delighted he has agreed to take on this dual role and am confident he will continue to provide extraordinary leadership and vision for the FDA.”

The US Department of Health and Human Services confirmed Prasad’s new roles, but didn’t provide further details.