After overcoming regulatory setbacks, Moderna (MRNA.US) has finally received approval for its first mRNA flu vaccine. The commercialization prospects still need to be verified.

After facing opposition from the U.S. Food and Drug Administration (FDA), Moderna's (MRNA.US) mRNA-based influenza vaccine, mFLUSIVA, has finally been approved for market, marking a significant victory for the company. Moderna stated in a press release that mFLUSIVA is approved for adults aged 50 and older. Specifically, it received traditional full approval for the 50 to 64 age group, while it received accelerated approval for those aged 65 and older. This is the first mRNA flu vaccine approved in the United States and the fifth product approved globally by Moderna, as well as the fourth FDA-approved product in the U.S. The mRNA influenza vaccine named mFLUSIVA is a key component of Moderna's business growth plan. As the demand for the COVID-19 vaccine, which elevated the company's profile during the pandemic, gradually wanes, Moderna is looking for new sources of growth. However, the pathway to approval for this vaccine has not been smooth. From the FDAs refusal to file letter issued in February of this year, to the 9-0 unanimous recommendation from the FDA advisory committee in June, and then to formal approval in August, the process also encountered changes in regulatory leadership and public backlash. The rare public disagreement between Moderna and regulators highlights the increasing politicization surrounding mRNA technology and vaccination issues in the U.S. In May 2025, after the FDA requested more data on a standalone flu vaccine, Moderna withdrew its application for the COVID-flu combination vaccine in the U.S. Although this combination vaccine was approved by European regulators in February this year, Moderna stated on July 31 that it is still waiting for guidance from the FDA regarding resubmission of its application in the U.S. Moderna's CEO, Stphane Bancel, stated in a press release: Influenza remains a significant public health challenge, and mFLUSIVA provides an important new option for older adults in the U.S. The company anticipates that the vaccine supply will be available in some retail channels in the coming weeks. The vaccine will join Moderna's existing products, including Spikevax (COVID-19), mRESVIA (RSV), and mNEXSPIKE (COVID-19), forming an mRNA product lineup covering major respiratory viruses. It is noteworthy that the accelerated approval of mFLUSIVA for adults aged 65 and older means Moderna will need to complete confirmatory clinical trials after launch to validate clinical benefits. Reports indicate that this confirmatory study is expected to enroll about 800,000 participants across two flu seasons. The influenza vaccine market has long been dominated by Sanofi (SNY.US), GlaxoSmithKline plc Sponsored ADR (GSK.US), CSL Seqirus, and AstraZeneca PLC Sponsored ADR (AZN.US). The approval of mFLUSIVA disrupts this landscape, making Moderna the first company to bring mRNA technology into the influenza market. The core advantages of mRNA vaccines lie in their production speed and flexibility. Traditional flu vaccines primarily rely on egg-based cultivation systems, often taking about six months from strain selection to production completion. In contrast, mRNA technology can design and produce vaccines within weeks after identifying the strain sequence, allowing for faster updates during mismatched strains in flu seasons. However, competitors are also advancing next-generation technologies. Therefore, the long-term competitiveness of mRNA in the flu market will depend on efficacy data, pricing strategy, and supply capabilities. Regarding the commercial outlook for mFLUSIVA, analysts predict that the vaccine will not generate significant revenue until the second half of 2027, as it misses the procurement cycle for the 2026 flu season. Jefferies Financial Group Inc. forecasts that U.S. sales will reach approximately $750 million by 2030 (including flu vaccines and the COVID-flu combination vaccine). Whether this expectation is reasonable will depend on mFLUSIVA's real-world performance in its first flu season.