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.
ModernamCOMBRIAX
Active
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.
Latest update Nov 10, 2026
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Current status
Approved by the European Commission on April 20, 2026 for adults 50 and older, valid across the EU plus Iceland, Liechtenstein, and Norway. Health Canada's Drug Product Database lists the Canadian brand MCOFLU as Approved on Nov. 4, 2026, DIN 02573288. The Nov. 6 Form 10-Q says mCOMBRIAX had not been commercialized as of Sept. 30, 2026. Exhibit 99.1 says the combination remains under review in Japan, the United Kingdom, and Australia, and that Moderna continues to await FDA guidance on a U.S. refiling. Those documents state no Canada availability date and no supply agreement.
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Specifications2
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Upcoming milestones1
Announced next steps from Moderna that mention mCOMBRIAX.
No date yet
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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More from Moderna6
- 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.
- Active
mFlusiva
Moderna's standalone mRNA seasonal influenza vaccine (mRNA-1010), the fourth product in its respiratory franchise alongside Spikevax, mRESVIA, and mCOMBRIAX.
- 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.
- In Development
mRNA-4194 (INTERCEPT-Lynch)
An investigational mRNA cancer-prevention vaccine, developed with the University of Oxford, designed to generate immune responses against early cancer-development targets in people with Lynch syndrome - Moderna's first program aimed at preventing cancer before it develops rather than treating existing disease.
- In Development
mRNA-1469
Investigational mRNA vaccine candidate against Bundibugyo ebolavirus. On Nov. 4, 2026 Moderna said WHO's Technical Advisory Group on Candidate Vaccine Prioritization recommended it for the Phase 2/3 Tumaini study in the Democratic Republic of the Congo after an Oct. 22 review. The study uses a ring-vaccination design and is co-sponsored by the Institut National de Recherche Biomedicale and the University of Antwerp. There is no licensed vaccine specifically indicated for Bundibugyo virus disease.
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