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# Moderna Wins Approval for mRNA Flu Vaccine
- URL: https://www.fdaweb.com/moderna-wins-approval-for-mrna-flu-vaccine/
- Published: 2026-08-06T12:00:00.000Z
- Updated: 2026-09-14T13:44:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161587

FDA has approved a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older. The approval follows a June Vaccines and Related Biological Products Advisory Committee meeting that supported the vaccine’s approval.

"The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform," the company said in a release.

FDA's approval covers mFLUSIVA in adults 50 through 64 years of age and is based on data from a randomized Phase 3 clinical trial (ClinicalTrials.gov Identifier: [NCT06602024](https://stats.nwe.io/x/html?final=aHR0cHM6Ly9wci5yZXBvcnQvYng5OA&sig=soPcOxDhW4Aj4GWyOQUTswRSKY6R6ei7WWC4niLL460rWBnh00fyYwcY%5FioyaOSMhW9s0%5FZlB5E4Kf8FR0rS-Q&hit%2Csum=WyI1Nm1kZnoiLCI1Nm1kZzAiLCI1Nm1kZnkiXQ&ref=fdaweb.com)), which enrolled 40,805 adults aged 50 years and older across 11 countries, according to the company. The vaccine’s use in adults 65 years of age and older was granted accelerated approval based on results from a randomized, active-controlled clinical trial (ClinicalTrials.gov Identifier: [NCT05827978](https://stats.nwe.io/x/html?final=aHR0cHM6Ly9wci5yZXBvcnQvb21pbA&sig=yJ2MpGF0nemnK63ULicLLucB1v7EONNac2ca9lI7KhCAERWKX5anEWowQK2z0Dwhqsh0gr8UN3e%5FxP9Pt0l0hQ&hit%2Csum=WyI1Nm1kZzEiLCI1Nm1kZzIiLCI1Nm1kZnkiXQ&ref=fdaweb.com)). The company says a required confirmatory study is underway for the older population to support a full-approval request.

Approval was uncertain following a February Refusal-to-File letter being issued and then reversed shortly thereafter. That application setback was attributed to concerns that the company’s Phase 3 trial used an inadequate control group to demonstrate efficacy. The agency determined that Moderna should have compared its vaccine to a high-dose influenza shot in older adults rather than a standard-dose comparator used across all age groups in the trial.

That ruling landed in a politically charged environment surrounding mRNA-based vaccines, a technology that became widely known during the Covid-19 pandemic. While many scientists view mRNA as a platform with transformative potential, it has also become a lightning rod in partisan debates over vaccine mandates, pandemic policy and federal health authority, critics argue. FDA quickly reversed its filing rejection, agreeing to review Moderna’s vaccine following what media reports described as an unusual, high-level meeting between agency leadership and the vaccine maker ([see earlier story](https://www.fdaweb.com/fda-flip-flops-agrees-to-now-review-moderna-vaccine/)).