FDA approves Moderna's mRNA flu vaccine for adults 50 and older
The U.S. Food and Drug Administration has authorized Moderna's mRNA-based influenza vaccine, mFLUSIVA, for use in adults aged 50 and above after advisory committee support and trial data showing strong efficacy and safety.
The Food and Drug Administration granted approval on Thursday for Moderna's mRNA-based influenza vaccine, mFLUSIVA (also known as mRNA-1010), for adults 50 years of age and older. The decision follows a unanimous vote by an FDA advisory committee in June, which cited the vaccine's higher efficacy compared with existing seasonal flu shots and a favorable safety profile from trials involving nearly 44,000 participants. The agency set an internal deadline of August 5 to finalize the approval.
The advisory panel highlighted the advantages of the mRNA platform, noting its rapid design flexibility and shorter manufacturing timeline—one to two months versus six to eight months for traditional egg-based vaccines.
"Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors," said Moderna CEO Stéphane Bancel. "This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation."
The vaccine's rollout may be affected by the lack of a current recommendation from the CDC's Advisory Committee on Immunization Practices, which has not met since a court ruling in March removed several members appointed by the health secretary. Without an ACIP endorsement, the inclusion of mFLUSIVA in federal vaccine programs and private insurance coverage remains uncertain.
Moderna expects the product to be available for the 2026-2027 flu season, though market analysts anticipate significant sales may not materialize until the following year.