Washington: A US Food and Drug Administration (FDA) advisory panel has voted unanimously to recommend the approval of Moderna’s seasonal influenza vaccine, mFlusiva, for adults aged 50 and older.
The endorsement marks a major step forward for the company, positioning it to potentially launch the first-ever mRNA-based flu shot in the United States.
The Vaccines and Related Biological Products Advisory Committee voted 9-0 in favor of the shot for adults aged 50 to 64, as well as those 65 and older, an age group that had previously drawn regulatory scrutiny.
Under former FDA Commissioner Marty Makary, the agency initially rejected Moderna’s application before shifting course. Following the panel’s positive recommendation, Moderna shares climbed 3.5 percent to close at $63.96, hitting their highest valuation since 2024.
Clinical data and strategic advantages
Moderna’s application relied on clinical data demonstrating the vaccine’s efficacy and advantages over traditional options:
- Age 50–64: Data showed mFlusiva outperformed standard-dose flu shots.
- Age 65+: A smaller, targeted study demonstrated that the vaccine generated a robust immune response comparable to existing high-dose flu shots.
Committee member and pediatric infectious disease physician Flor Munoz-Rivas noted that beyond immediate trial success, mRNA technology offers a critical advantage for public health preparedness.
Traditional flu vaccines require months of manufacturing time following strain selection. In contrast, mRNA platforms enable significantly faster production, allowing strains to be selected much closer to the actual flu season, similar to how COVID-19 vaccines are updated.
Decision in August
If the FDA follows its committee’s guidance, mFlusiva will enter a competitive market currently dominated by traditional flu shots from Sanofi, GSK, CSL Seqirus, and AstraZeneca.
An official FDA approval decision is expected by August 5. While Moderna executives aim to distribute the vaccine for the upcoming flu season, Citi analyst Geoff Meacham noted that meaningful revenue may not materialize until the second half of 2027, as Moderna missed the US flu vaccine contracting window for the current year.
Nevertheless, analysts see broader strategic value in the decision. Jefferies analyst Andrew Tsai forecasted $750 million in US sales for Moderna’s standalone flu shot and its combination COVID-flu vaccine by 2030.
Tsai highlighted that a regulatory win for mFlusiva is a strong positive indicator for the combination shot, which is already approved in the European Union but still awaits US clearance.
The approval would validate the long-term commercial viability of Moderna’s mRNA technology as the company looks to diversify beyond its pandemic-era portfolio.
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