Vinay Prasad Out at CBER for Second Time in Under a Year

Dr. Vinay Prasad is leaving FDA… again.

An FDA spokesperson confirmed that the agency’s head of the Center for Biologics Evaluation and Research (CBER) is stepping down on Friday, March 6, NBC News reports.¹ In the role, Prasad played a key role in shaping the administration’s vaccine policy.

In a post on X,² FDA chief Dr. Marty Makary wrote, “A year ago, Dr. Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified covid vaccine framework, & the new plausible mechanism framework for ultra rare diseases which we launched last week. Also, under his leadership, his center hit a record number of approvals in Dec. He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month. We will name a successor before his departure.”

The statement concludes, “I want to thank him for his service and personal sacrifice to take time away from his family.”

This is the second time in under a year that Prasad has left the role as head of CBER, despite only joining the agency in early 2025. However, after stepping down in late July, Prasad stepped back into the role in early August.

His departure came on the heels of a series of controversial drug decisions at FDA. Primarily, the agency issued CRLs over Replimune and Capricor which were criticized for not providing the drug makers with clear communication during the mid- and late-cycle reviews.

At the time, an FDA spokesperson told news outlets, “"Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family. We thank him for his service and the many important reforms he was able to achieve in his time at FDA.”

Also, unconfirmed reports surfaced that Prasad left the position due to pressure from President Trump. Some prominent right-wing influencers targeted Prasad over his previous statements supporting Democrats and his handling certain drug controversies. These reports remain unconfirmed, and Prasad would quickly rejoin the agency.

Prasad remained a controversial figure at the agency. In November, 2025, he issued a memo claiming that the COVID 19 vaccine was responsible for the deaths of 10 children.³ However, the memo did not include details about these deaths and statement remains unconfirmed.

Prasad also oversaw an overhaul for future CAR-T approvals, which removed the requirement for REMS reporting but adding proof that the therapies show superiority over existing treatments.

At the time, Prasad wrote, “Evidence should generally demonstrate superiority of the investigational CAR T-cell therapy compared with control. Any plan to establish effectiveness of a new CAR T-cell product compared with an approved CAR T-cell therapy based on demonstration of equivalence or noninferiority must be adequately justified and discussed with the FDA.”

Prasad also played a role in FDA’s decision to drop the two-study requirement from its New Drug Approval process earlier this year. The CBER chief, along with FDA Commissioner Makary, explained that they believed that advances in clinical and statistical science made it unnecessary to burden drug makers with the requirement to hold two trials. The decision was part of the agency’s desire to speed up and simplify the approval process.

Sources

1. FDA vaccine chief to leave the agency for a second time. NBC News. March 6, 2026. https://www.nbcnews.com/health/health-news/fda-vaccine-chief-leave-second-time-rcna262170
2. Marty Makary X Post. X. March 6, 2026. https://x.com/DrMakaryFDA/status/2030048453384929548
3. FDA claims Covid shots killed 10 children and vows new vaccine rules. NBC News. November 29, 2025. Accessed March 9, 2026. https://www.nbcnews.com/health/health-news/fda-covid-vaccines-children-deaths-rcna246437