The Zhitong Finance App learned that after being previously opposed by the US Food and Drug Administration (FDA), the influenza vaccine mFlusiva developed by Moderna (MRNA.US) was finally approved for marketing. This is certainly a major victory for the company.
Moderna said in a statement that mFlusiva has been approved for use by adults aged 50 and above. Among them, traditional full approval was obtained for people aged 50 to 64, while accelerated approval was obtained for people aged 65 and above. This is the first mRNA influenza vaccine approved in the US. It is also Moderna's 5th product approved globally, and the 4th FDA product approved in the US.
This mRNA influenza vaccine, called mFlusiva, is an important part of Moderna's plans to drive business growth. As demand for the COVID-19 vaccine that helped the company become famous during the pandemic gradually subsides, Moderna is seeking new growth drivers.
However, the vaccine's path to approval has not been easy. From the FDA issuing a “refusal to accept” letter in February of this year, to the full 9-0 recommendation by the FDA Advisory Committee in June, to formal approval in August, it also experienced personnel changes in senior supervisory personnel and a backlash in public opinion.
A rare public disagreement between Moderna and regulators highlights the extent to which the US is increasingly politicized over mRNA technology and vaccination issues. In May 2025, Moderna withdrew its application for the COVID-influenza combination vaccine in the US after the FDA requested more data on a single influenza vaccine. Although the combination vaccine was approved by European regulators in February of this year, Moderna said on July 31 that the company is still awaiting FDA guidance on resubmitting the US application.
Moderna CEO Stéphane Bancel said in a statement: “The flu remains a major public health challenge, and mFlusiva provides an important new option for America's seniors.” The company said it expects to supply the vaccine in some retail channels in the next few weeks. The vaccine will be juxtaposed with Moderna's existing Spikevax (COVID-19), mResVIA (RSV), and mNexSpike (COVID-19) to form an mRNA product portfolio covering major respiratory viruses.
Notably, mFlusiva's accelerated approval for adults aged 65 and over means Moderna will need to complete confirmatory clinical trials after marketing to verify clinical benefits. According to reports, the confirmatory study is expected to recruit about 800,000 people, spanning two influenza seasons.
The influenza vaccine market has long been dominated by Sanofi (SNY.US), GlaxoSmithKline (GSK.US), CSL Seqirus, and AstraZeneca (AZN.US). The approval of mFlusiva broke this pattern, making Moderna the first company to bring mRNA technology to the influenza market. The core advantage of mRNA vaccines is the speed and flexibility of production. Traditional influenza vaccines mainly rely on egg culture systems, and it usually takes 6 months from selection of the strain to completion of production. mRNA technology can be designed and produced within weeks of strain sequencing, which means mRNA vaccines can be updated more quickly when strain mismatches occur during the influenza season. But at the same time, competitors are also deploying next-generation technology. Therefore, the long-term competitiveness of mRNA in the influenza field depends on efficacy data, price positioning, and supply capacity.
Regarding the commercialization prospects of mFlusiva, analysts expect that mFlusiva will not generate meaningful revenue until the second half of 2027 because it missed the 2026 influenza season procurement cycle. Jefferies predicts US sales of approximately US$750 million in 2030 (including influenza vaccine and COVID-influenza combination vaccine). Whether this expectation is reasonable will depend on how mFlusiva performs in the real world during the first influenza season.