FDA Revisits Decision on Moderna's mRNA Flu Vaccine Amid Industry Uncertainty

Moderna sought U.S. approval for an mRNA flu vaccine, but the FDA unexpectedly declined to review the application in February, shocking the company and the broader pharmaceutical industry. Following a promise to conduct a post-market confirmatory study, the agency reversed its stance and agreed to evaluate the candidate. A federal advisory committee has since voted in favor of approval, and the FDA faces a Wednesday deadline to issue a final ruling.

The back-and-forth has unsettled investors, who rely on consistent regulatory signals, especially after the Department of Health and Human Services cut nearly $500 million in mRNA research funding. Experts warn that the outcome will influence the prospects of smaller biotech firms developing mRNA therapies. Meanwhile, patients like Janusz Racz, who benefited from an mRNA cancer vaccine trial, watch the regulatory debate closely.