FDA Approves First mRNA Flu Vaccine in the U.S., Though Commercial Path Remains Uncertain

Aug 17 , 2026
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Aug 17, 2026 —

The U.S. Food and Drug Administration (FDA) has approved Moderna’s messenger RNA (mRNA) influenza vaccine, for adults aged 50 and older — the first approved mRNA flu vaccine in the United States.

For adults 65 and older, the agency used its accelerated approval pathway, meaning continued approval for that group could depend on a confirmatory trial. The approval marks an expansion of mRNA vaccine technology beyond COVID-19, building on the platform Moderna scaled during the pandemic.

Analysts note that commercial success is not assured, with uptake likely to depend on public-health recommendations, competition from established flu vaccines, and the evolving policy environment. Moderna continues to develop combination and next-generation respiratory vaccines using the same mRNA platform.

Source:

https://www.biopharmadive.com/news/moderna-mrna-flu-vax-fda-nod-blockbuster-hurdles/828190/

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PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

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