FDA Approves Moderna’s mRNA Influenza Vaccine

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend approval of the Moderna’s investigational mRNA influenza vaccine, which will be marketed under the brand name mFlusiva, for the prevention of flu in adults age 50 to 64. VRBPAC also voted in support of accelerated approval in adults aged 65 and older. However, Moderna will be required to conduct a Phase IV, post-marketing study to demonstrate effectiveness in the older group.

Approval was based on data from the Phase III trial, which involved nearly 41,000 adults 50 years and older in 11 countries during the 2024-25 flu season. The trial found mRNA-1010 provided significantly better protection against flu-like illness than standard-dose shots, with a relative vaccine efficacy of 27 percent. Immunogenicity data indicated efficacy in the 65 and over group.

VRBPAC members reviewed the data to vote on two questions: Do the benefits of mFlusiva outweigh the risks for the prevention of flu in adults aged 50 to 64, and do the benefits outweigh the risks in adults aged 65 and older? For the second question, members had to decide whether the immunogenicity results from the Phase III trial provided a reasonable basis to predict clinical benefit.

“We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform,” said Moderna CEO Stephane Bancel, MBA, MSc. “We look forward to continuing to work with the FDA as it completes its review.”