New mRNA flu vaccine cleared for U.S. use for the first time

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The FDA has approved Moderna’s mFLUSIVA, the first mRNA-based seasonal flu vaccine in the United States for adults aged 50 and older. In a large clinical trial, the vaccine was 26.6% more effective than a standard-dose flu shot. Its mRNA technology may allow vaccines to be developed and updated more quickly as circulating flu strains change. Moderna expects the vaccine to be available this fall.

Source

Leroux-Roels, I., Huang, G., Ferguson, M., Kohli, A., Clark, R., Bickel, M., Soens, M., Du, E., Pucci, A., Hicks, B., Eschen, C., Das, R., Wilson, E., & Fluent Trial Investigators (2026). Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults. The New England journal of medicine, 394(18), 1803–1813. https://doi.org/10.1056/NEJMoa2516491

Additional Reading

https://www.cnn.com/2026/08/05/health/moderna-mrna-flu-vaccine

https://www.pbs.org/newshour/health/new-kind-of-flu-shot-is-on-the-way-as-the-fda-approves-modernas-mrna-based-vaccine

https://time.com/article/2026/08/06/fda-approves-first-mrna-flu-vaccine/

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