After facing initial opposition from the U.S. Food and Drug Administration (FDA), Moderna, Inc. has achieved a significant milestone with the approval of its mRNA-based influenza vaccine, mFLUSIVA. The company announced that mFLUSIVA is authorized for adults aged 50 and older, receiving a traditional full approval for those aged 50 to 64 and an accelerated approval for individuals aged 65 and above. This marks the first authorized mRNA flu vaccine in the United States and the fifth product globally approved for Moderna, Inc., as well as its fourth FDA-approved product in the U.S.
The approval of mFLUSIVA is a key component of Moderna, Inc.'s strategy to diversify its revenue streams as demand for its COVID-19 vaccine, which initially propelled the company to prominence, continues to decline. However, the path to approval was fraught with challenges, including a "refuse to file" letter from the FDA in February, a unanimous 9-0 recommendation from an FDA advisory committee in June, and final approval in August. These events were accompanied by regulatory leadership changes and public backlash. The rare public disagreement between Moderna, Inc. and the FDA underscores the increasing politicization of mRNA technology and vaccination in the U.S.
In May 2025, Moderna, Inc. withdrew its application for a combined COVID-19 and flu vaccine in the U.S. after the FDA requested additional data on standalone flu vaccines. While this combination vaccine received approval from European regulators in February, Moderna, Inc. stated on July 31 that it is still awaiting FDA guidance on resubmitting its U.S. application. Moderna, Inc. CEO Stéphane Bancel commented, "Influenza remains a significant public health challenge, and mFLUSIVA provides a crucial new option for older adults in the United States." The company expects to make the vaccine available at select retail pharmacies in the coming weeks.
Understanding the Core of This Development
mFLUSIVA joins Moderna, Inc.'s existing portfolio of Spikevax (COVID-19), mRESVIA (RSV), and mNEXSPIKE (COVID-19), creating a comprehensive mRNA-based product lineup targeting major respiratory viruses. Notably, the accelerated approval for those aged 65 and older requires Moderna, Inc. to conduct a confirmatory clinical trial post-launch to verify clinical benefits. This trial is expected to enroll approximately 800,000 participants over two flu seasons.
The flu vaccine market has long been dominated by Sanofi, GlaxoSmithKline, CSL Seqirus, and AstraZeneca. The approval of mFLUSIVA disrupts this landscape, positioning Moderna, Inc. as the first company to bring mRNA technology into the flu market. The key advantage of mRNA vaccines lies in their production speed and flexibility. Traditional flu vaccines, which rely on egg-based systems, typically take six months from strain selection to production. In contrast, mRNA technology can design and produce a vaccine within weeks of identifying the strain sequence, allowing for quicker updates during flu seasons when strain mismatches occur. However, competitors are also advancing next-generation technologies, meaning the long-term competitiveness of mRNA in the flu sector will depend on efficacy data, pricing, and supply capabilities.
Assessing the Commercial Outlook
Regarding the commercial prospects of mFLUSIVA, analysts do not expect it to generate meaningful revenue until the second half of 2027, as it has missed the procurement cycle for the 2026 flu season. Jefferies projects U.S. sales of approximately $750 million by 2030, encompassing both the flu vaccine and a combined COVID-19 flu vaccine. The validity of these projections will depend on the real-world performance of mFLUSIVA during its first flu season.
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