Active
Spikevax
Moderna's original COVID-19 mRNA vaccine (mRNA-1273), the product that validated mRNA vaccines at global scale. Now sold as a seasonal respiratory vaccine and the company's largest historical revenue driver.
ModernamFlusiva
Active
Moderna's standalone mRNA seasonal influenza vaccine (mRNA-1010), the fourth product in its respiratory franchise alongside Spikevax, mRESVIA, and mCOMBRIAX.
Latest update Sep 8, 2026
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Current status
FDA-approved August 5, 2026 for adults 50 and older, with the 65+ indication cleared under accelerated approval contingent on a postmarketing study. In Moderna's Phase 3 trial of over 40,000 adults 50+, mFlusiva was about 27% more effective than a standard flu shot over the 2024-25 season. Moderna expects the vaccine available in the US for the 2026-2027 flu season; filings are under review in the EU, Canada and Australia.
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Specifications2
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Upcoming milestones1
Announced next steps from Moderna that mention mFlusiva.
Date not announced
Resubmit mCOMBRIAX (mRNA-1083) US application
TargetTiming not yet announced
Resubmit the US Biologics License Application for mCOMBRIAX, the flu-plus-COVID combination vaccine already approved in the EU. Moderna withdrew the original 2024 US application in May 2025 after the FDA requested Phase 3 influenza-efficacy data; that data has now been delivered via mFlusiva's August 5, 2026 approval, clearing the path to resubmit. Moderna has still not announced a specific resubmission timeline, and the FDA's rare refusal-to-file letter on mFlusiva earlier in 2026 (reversed on appeal) could add further delay before the combination shot is refiled.
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In the news2
FDA approves Moderna's mFlusiva, the first mRNA flu vaccine
The FDA approved Moderna's mFlusiva on August 5, the first influenza vaccine built on mRNA technology, granting standard approval for adults 50 to 64 and accelerated approval for those 65 and older pending a postmarketing study. In the Phase 3 trial, mFlusiva showed about 27% higher relative efficacy against confirmed influenza-like illness than a standard-dose comparator, and Moderna expects it available in time for the 2026-2027 flu season, becoming the company's fourth approved respiratory product.
FDA approves Moderna's mFlusiva, its first standalone flu shot
The FDA approved Moderna's mFlusiva (mRNA-1010) on August 5 for seasonal influenza in adults 50 and older, with the 65-plus indication cleared under accelerated approval pending a postmarketing study. In Moderna's Phase 3 trial of more than 40,000 adults 50 and older, the shot was about 27% more effective than a standard flu vaccine over the 2024-25 season, and Moderna expects it available for adults 50-plus this fall as a fourth product in its respiratory franchise.
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More from Moderna5
- Active
mRESVIA
mRNA vaccine (mRNA-1345) against respiratory syncytial virus (RSV) - the first mRNA vaccine approved for a disease other than COVID-19, and a key pillar of Moderna's expanding respiratory franchise.
- In Development
Intismeran autogene (mRNA-4157)
An individualized neoantigen cancer therapy, co-developed with Merck, that is custom-manufactured for each patient's tumor mutations and given with KEYTRUDA to train the immune system against the cancer. It is Moderna's highest-value pipeline asset.
- Active
mCOMBRIAX
Moderna's combination COVID-19 and influenza vaccine (mRNA-1083), the world's first authorized flu-plus-COVID combination vaccine, delivered as a single shot.
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