FDA Approves First mRNA-Based Flu Vaccine, Highlighting Growing Patent Value in mRNA Platforms

Key Takeaway: The FDA’s approval of mFLUSIVA may indicate increased commercial and strategic value of mRNA vaccine patents.

On August 5, 2026, Moderna announced that the U.S. Food and Drug Administration (FDA) approved mFLUSIVA® (mRNA-1010), a seasonal influenza vaccine for adults 50 years of age and older.[1] The approval makes mFLUSIVA the first FDA-approved mRNA-based vaccine directed to seasonal influenza.[2]

mFLUSIVA had an unusual regulatory path. Early in 2026, FDA reportedly issued a refusal-to-file letter and initially declined to review Moderna’s application, citing concerns about the comparator used in one of Moderna’s Phase 3 studies.[3] FDA then reversed course, accepted an amended application, and approved the vaccine following unanimous support from the agency’s Vaccines and Related Biological Products Advisory Committee.[4]

mRNA vaccine technology may offer practical advantages for seasonal influenza. Traditional influenza vaccines can require months of manufacturing after strain selection, while mRNA platforms may allow faster updates to better match circulating strains.[5] FDA granted traditional approval for adults ages 50 through 64 and accelerated approval for adults 65 and older, with confirmation of clinical benefit in the older population to be assessed in a postmarketing study.[6]

mRNA vaccine developers may be cautiously optimistic in view of mFLUSIVA’s approval, though FDA scrutiny of clinical trial design remains significant. For patent holders and applicants, mFLUSIVA’s approval may signal increased value in mRNA-based vaccine intellectual property, as such technology appears to have a viable regulatory pathway, despite earlier indications that such mRNA technology would face skepticism under the current administration.[7]

Editor: Brenden S. Gingrich, Ph.D.

[1] Moderna, Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVA (Aug. 6, 2026), https://feeds.issuerdirect.com/news-release.html?newsid=4801915282452025&symbol=MRNA.

[2] See FDA, August 5, 2026 Approval Letter—MFLUSIVA, https://www.fda.gov/media/194121/download?attachment.

[3] Fierce Pharma, Moderna’s mRNA flu shot mFlusiva snags FDA nod after refusal-to-file imbroglio (Aug. 5, 2026), https://www.fiercepharma.com/pharma/modernas-mrna-flu-shot-mflusiva-snags-fda-nod-after-refusal-file-imbroglio.

[4] BioPharma Dive, FDA approves Moderna’s mRNA flu vaccine (Aug. 6, 2026), https://www.biopharmadive.com/news/moderna-fda-approve-mflusiva-seasonal-influenza/826864/.

[5]Fraiser Kansteiner, Moderna Gets FDA Approval for mRNA Flu Vaccine, But CDC Input Still Uncertain, MedCity News (Aug. 6, 2026), https://medcitynews.com/2026/08/moderna-flu-vaccine-fda-approval-mflusiva-acip-cdc-mrna/.

[6] See FDA, August 5, 2026 Approval Letter—MFLUSIVA.

[7] See, e.g., Amanda Seitz, RFK Jr. Pulls $500 million in funding for vaccine development, The Associated Press (August 5, 2025) https://apnews.com/article/kennedy-vaccines-mrna-pfizer-moderna-1fb5b9436f2957075064c18a6cbbe3c9.