FDA approves 1st mRNA flu shot, from Moderna

Key Points:

• The FDA approved mFlusiva, the U.S.' first mRNA-based flu vaccine from Moderna, for adults aged 50 and above, contingent on an additional trial for those 65 and older; it showed about 27% greater effectiveness than standard flu shots in late-stage trials.
• mRNA technology enables faster vaccine production, allowing Moderna to develop flu shots in 2-3 months versus six months for traditional vaccines, potentially improving strain matching.
• Despite approval, challenges remain as the CDC’s vaccine advisory committee (ACIP) is blocked from convening, limiting formal recommendations, insurance coverage, and public distribution of mFlusiva.
• The FDA initially hesitated to review Moderna's application due to trial design concerns but reversed its decision after the vaccine advisory committee unanimously recommended approval based on a large international trial.
• Moderna plans to make mFlusiva available for the upcoming flu season, though uptake may be constrained without ACIP endorsement, which is critical for insurance reimbursement and federal vaccine programs.