FDA Reverses Decision About Moderna Flu Vaccine

The FDA initially refused to even look at Moderna's application for an mRNA flu vaccine, citing insufficient data from early trials. This was highly unusual because Moderna had previously consulted with the FDA on their data package and testing plan, receiving assurances that their approach was acceptable.

Moderna had invested over a billion dollars and tested the shot on 40,000 people, following FDA's previously accepted plan. The FDA's refusal to review, rather than reject, is an extreme step typically reserved for missing application pieces or data integrity concerns.

Reporting revealed that Vinnie Prasad, an appointee of Robert F. Kennedy Jr. in the division overseeing vaccine safety, overruled senior FDA scientists to refuse Moderna's application. Prasad insisted on an extra test that the FDA had previously deemed optional.

Reporters at Stat and the Wall Street Journal uncovered that Vinnie Prasad, Kennedy's guy, overruled senior scientists, demanding an extra test for the over 65 population that the FDA had previously said was acceptable to omit.

Following a significant outcry from the pharmaceutical industry and reported meetings involving the White House and FDA officials, the FDA reversed its decision. They agreed to review Moderna's application after all, with Moderna making a minor concession to split its approval request for different age groups.

Reporting indicated the White House met with FDA officials, who then met with Moderna, leading to the FDA agreeing to look at the application. Moderna's modification was to seek separate approval for under 65 and over 65 populations, addressing the specific data concern.

This incident is part of a broader pattern of actions, including the pulling of government support for mRNA vaccine research and scaled-back childhood vaccine recommendations, creating a 'headwind' for the vaccine industry. This regulatory chaos and political influence deter investment and innovation in critical vaccine technologies.

Kennedy pulled hundreds of billions in government support for mRNA vaccine research for future pandemics. Moderna has already pulled back on investments in other vaccine research. The CDC scaled back childhood vaccine recommendations and language on its website questions vaccine-autism links, despite scientific consensus.