Moderna's mRNA Flu Vaccine Sees Dramatic FDA Reversal

Moderna's application for its new flu vaccine has been accepted by the FDA following an initial rejection. This marks a notable shift in vaccine oversight during the Trump administration, raising concerns about policy volatility. The agency's about-face may restore revenue prospects for the vaccine.

The U.S. Food and Drug Administration reversed its stance on Moderna's new flu vaccine, accepting an amended application after initially refusing to review it. This unexpected decision comes amidst policy shifts at the FDA during the Trump administration, which has caused unrest among drugmakers and investors.

The reversal may pave the way for the first mRNA-based flu vaccine in the U.S. but has highlighted volatility at the FDA during Robert F. Kennedy Jr.'s tenure. Under scrutiny for not giving older trial participants higher-strength doses, Moderna agreed to conduct further studies for full approval.

The FDA's quick reversal has stirred concerns about vaccine policy changes that have already impacted vaccination rates. Analysts suggest Moderna may leverage public pressure against mRNA skeptics in the agency, potentially reviving a significant revenue stream.

(With inputs from agencies.)