Introduction to the FDA Vaccine Chief’s Return

The Food and Drug Administration (FDA) has announced the return of Dr. Vinay Prasad as the agency’s top vaccine regulator. This decision comes less than two weeks after he was pressured to step down due to criticism from biotech executives, patient groups, and conservative allies of President Donald Trump.

Background on Dr. Vinay Prasad’s Previous Role

Dr. Prasad previously led the FDA center responsible for regulating vaccines and biotech therapies. However, he faced opposition due to his past statements criticizing President Trump, which drew the ire of right-wing activists, including Laura Loomer. Loomer referred to Prasad as "a progressive leftist saboteur" and noted his history of praising liberal independent Sen. Bernie Sanders.

Controversy Surrounding Gene Therapy

A significant controversy surrounding Dr. Prasad’s leadership was his decision to pause the shipment of a gene therapy for Duchenne’s muscular dystrophy after two patient deaths. This action was met with pushback from families of boys with the fatal condition and libertarian supporters of increased access to experimental medicines. The FDA eventually reversed its decision to suspend the therapy’s use.

Support from FDA Commissioner and Health Secretary

Despite the criticism, Dr. Prasad has had the backing of FDA Commissioner Marty Makary and health secretary Robert F. Kennedy Jr. Both have called for scrutinizing the use of COVID-19 vaccines. Under Dr. Prasad’s leadership, the FDA restricted the approval of two new COVID-19 shots from vaccine makers Novavax and Moderna and set stricter testing requirements for future approvals.

Recent Developments and Return to the FDA

A spokesperson for the Department of Health and Human Services announced Dr. Prasad’s return to his role as the top vaccine regulator in a statement on Monday. This move is seen as a significant development in the FDA’s approach to vaccine regulation. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Originally Published: August 11, 2025 at 11:25 AM EDT

Conclusion

Dr. Vinay Prasad’s return to the FDA as the top vaccine regulator marks a significant shift in the agency’s approach to vaccine regulation. With his history of scrutinizing vaccine approvals and his support from key figures like FDA Commissioner Marty Makary and health secretary Robert F. Kennedy Jr., Dr. Prasad’s leadership is expected to have a notable impact on the FDA’s decisions regarding COVID-19 vaccines and other biotech therapies.

FAQs

• Q: Why was Dr. Vinay Prasad initially pressured to step down from his role at the FDA?
  A: Dr. Prasad faced criticism due to his past statements criticizing President Trump and his decision to pause the shipment of a gene therapy for Duchenne’s muscular dystrophy.
• Q: Who supported Dr. Prasad’s return to the FDA?
  A: Dr. Prasad has had the backing of FDA Commissioner Marty Makary and health secretary Robert F. Kennedy Jr.
• Q: What changes can be expected under Dr. Prasad’s leadership?
  A: Under Dr. Prasad’s leadership, the FDA is expected to continue scrutinizing vaccine approvals, including stricter testing requirements for future approvals.