FDA Approves Moderna's mRNA Flu Shot for Adults 50+, Launch Set for Next Season
MRNA has more than doubled off its 52-week low of $22.28 on light trading volume (0.4× avg).
Summary
The FDA approved Moderna's mFLUSIVA (mRNA-1010) seasonal flu vaccine for adults 50 and older, marking the company's first non-COVID vaccine approval. Standard approval covers ages 50-64 based on a 40,805-participant Phase 3 trial; accelerated approval for 65+ requires a postmarketing confirmatory study. Moderna plans a U.S. launch for the 2026-2027 respiratory season, adding to its respiratory portfolio alongside Spikevax and mRESVIA. This follows a unanimous advisory committee vote in June and comes just days after a disappointing Q2 report that included a norovirus vaccine failure and a $782 million net loss. The approval diversifies revenue beyond COVID and RSV, directly addressing the cash burn concern. International reviews are underway in the EU, Canada, and Australia. Separately, Moderna started a Phase 1 trial for an Ebola vaccine with CEPI backing up to $50 million.
At the time of this announcement, MRNA was trading at $54.51 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $21.8B. The 52-week trading range was $22.28 to $85.60. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Benzinga.