Moderna Wins FDA Approval for mRNA Flu Shot

The US Food and Drug Administration (FDA) has approved the first mRNA influenza vaccine for adults aged 50 and older. Moderna said it plans to make the vaccine available for the upcoming flu season.

In a clinical trial involving more than 40,000 participants aged 50 and older, the vaccine was about 27% more effective than standard influenza vaccines during the 2024–2025 flu season.

The most common side effects were pain at the injection site, fatigue, headache, muscle and joint pain, nausea, vomiting and fever. Moderna says mRNA technology also shortens the time needed to adapt vaccines to circulating influenza strains, potentially improving their effectiveness.

In February, the FDA initially refused to review Moderna's application, citing concerns about the design of its clinical trial rather than safety or efficacy data. Two weeks later, the agency reversed its decision and accepted the application for review. In June, an independent FDA advisory committee unanimously concluded that the vaccine's benefits outweigh its risks.

(CNN, bak)