FDA Approves First mRNA Flu Vaccine

The FDA has approved Moderna’s influenza vaccine, mFlusiva, for use in adults aged 50 years and older after positive Phase III results in a trial of more than 40,000 people in this age group.

This makes Moderna the first company to get an approval for an mRNA flu vaccine from the U.S. regulator, although others are in development. This adds to the company’s two FDA approved COVID vaccines, Spikevax and mNextspike, and mResvia, an approved vaccine against lower-respiratory-tract disease caused by respiratory syncytial virus.

“The FDA approval of mFlusiva, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform,” said Stéphane Bancel, chief executive officer of Moderna, in a press statement.