FDA Chief Overruled Staff to Reject Moderna Flu Vaccine Application | STAT

WASHINGTON — Vinay Prasad, a top official at the Food and Drug Administration, overruled the agency’s internal reviewers in rejecting Moderna’s application for a novel influenza vaccine, according to three agency officials familiar with the decision. The move signals increasing skepticism toward vaccine development within the FDA, coinciding with the Biden administration’s appointment of known vaccine critic Robert F. Kennedy Jr. As Health and Human Services Secretary.

The career scientists within the FDA were prepared to review the data submitted by Moderna, and David Kaslow, head of the FDA’s Office of Vaccine Research and Review, authored a memo advocating for the application to proceed through the standard review process. Despite this recommendation, Prasad declined to allow the review to move forward, STAT News reported.

The FDA’s refusal to review Moderna’s mRNA influenza vaccine application was confirmed by multiple news outlets, including the New York Times and BioPharma Dive. The decision is particularly notable given the significant investment Moderna has made in mRNA technology, initially lauded for its success in developing COVID-19 vaccines. BioSpace reported that the details of the rejection letter were unexpected within the industry.

This decision follows a pattern of increased scrutiny of vaccines under Prasad’s leadership. Alongside Prasad, Tracy Beth Høeg, another top FDA official, has been involved in shifting control of vaccine surveillance away from established civil servants within the agency, according to STAT News. The extent of the changes to vaccine surveillance protocols remains unclear.

The FDA has not publicly commented on the specific reasons for rejecting Moderna’s application, nor has it addressed the allegations of overruling staff recommendations. Moderna has also not released a public statement regarding the FDA’s decision.