Moderna’s mFlusiva is the first mRNA-based seasonal flu vaccine to receive US approval for adults aged 50 and older.
RT’s Three Key Takeaways:
- First mRNA Flu Vaccine: The FDA approved Moderna’s mFlusiva, the first seasonal influenza vaccine using mRNA technology to enter the US market.
- Broad Adult Indication: The vaccine is approved for all adults aged 50 and older, with the 65 and older population receiving accelerated approval based on immunogenicity data.
- Upcoming Season Availability: Moderna plans to have the vaccine available for the 2026-2027 respiratory virus season, alongside its existing vaccines for COVID-19 and respiratory syncytial virus.
The USFDA has approved Moderna’s mFlusiva (mRNA-1010), a new vaccine for seasonal influenza in adults 50 years and older, according to the company. The approval follows a unanimous recommendation from the FDA Vaccines and Related Biological Products Advisory Committee.
The decision marks the first time an mRNA-based influenza vaccine has been approved in the US, according to Moderna.
“The FDA approval of mFlusiva, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform,” said Stéphane Bancel, chief executive officer of Moderna, in a news release. “Flu remains a significant public health challenge, and mFlusiva provides an important new option for America’s seniors.”
For adults aged 50 through 64, the FDA based its approval on results from a randomized Phase 3 clinical trial that enrolled 40,805 participants across 11 countries, the company stated. The study evaluated the safety and relative vaccine efficacy of mFlusiva compared to a standard dose active comparator against influenza A and B strains.
The vaccine received accelerated approval for adults aged 65 and older based on immunogenicity results from a clinical trial of 2,992 adults in the US, according to Moderna. This trial compared mFlusiva to a high-dose inactivated influenza vaccine. The company noted that continued approval for this age group may be contingent upon the verification of clinical benefit in a confirmatory post-marketing trial.
The Phase 3 program demonstrated an acceptable safety profile with no new safety concerns identified, according to the news release. Reported side effects included injection site pain, fatigue, headache, and muscle pain. Patients are advised to consult their healthcare provider regarding allergies or previous reactions to influenza vaccines.
Moderna expects to have mFlusiva available for the 2026-2027 respiratory virus season. The vaccine will be available alongside the company’s other respiratory products, including Spikevax for COVID-19 and mResvia for respiratory syncytial virus.
