Moderna's mRNA Flu Vaccine Sees Dramatic FDA Reversal

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.