FDA approves Moderna's mRNA flu vaccine after initial pushback

The U.S. Food and Drug Administration (FDA) has approved Moderna's mFLUSIVA, a new seasonal flu vaccine utilizing mRNA technology. This landmark approval, announced Wednesday, is for adults aged 50 and older, making it the first influenza vaccine based on mRNA technology to receive FDA clearance.

Moderna expressed gratitude for the milestone, stating, "This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation." The company thanked clinical trial participants, investigators, regulators, and its own teams for their contributions.

The approval comes despite earlier criticism of mRNA technology by Health and Human Services Secretary Robert F. Kennedy Jr., who had previously canceled 22 vaccine development projects using the technology. The FDA had initially indicated it would not consider Moderna's application but reversed its stance after discussions led to a revised regulatory approach and an amended application.

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This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.

The dispute centered on a clinical trial involving 40,000 participants, which found Moderna's vaccine to be more effective in adults over 50 compared to a standard flu shot. However, the FDA vaccine director had raised concerns about the trial not including another specific brand recommended for those 65 and older. Moderna subsequently modified its application to seek full approval for adults aged 50-64 and accelerated approval for those 65 and older, also agreeing to conduct an additional study on the drug's use in older adults.

Moderna anticipates mFLUSIVA will be available for the 2026-27 flu season.

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We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible.