FDA approved Moderna's MFlusiva for adults age 50 and older, making it the first mRNA vaccine approved for seasonal influenza. Moderna expects the vaccine to be available in the United States for the 2026 to 2027 flu season.
In the pivotal study, MFlusiva reduced influenza like illness by 27 percent compared with a standard dose flu vaccine in adults age 50 and older. No new serious safety concerns were identified. The approval gives Moderna its first major opportunity to establish the mRNA platform in a routine seasonal market beyond COVID.
Study results and approval terms
The pivotal study compared MFlusiva with a licensed standard dose influenza vaccine in adults age 50 and older. Moderna reported a 27 percent relative reduction in influenza like illness and no new serious safety concerns.
The portion of the approval covering adults age 65 and older was granted under the accelerated approval pathway. Moderna must conduct postmarketing work over two influenza seasons to confirm the vaccine's clinical benefit in that age group.
MFlusiva reported less influenza like illness
Relative incidence, standard dose flu vaccine = 100
27% relative reduction
Source: Moderna pivotal study results reported by BioPharma Dive. Adults age 50 and older.Moderna enters an established vaccine market
MFlusiva will compete with established influenza vaccines sold through pharmacies, physician offices and health systems. Several enhanced vaccines are already available for older adults, including high dose and adjuvanted products.
Moderna has argued that mRNA manufacturing could allow vaccine strains to be selected closer to the start of a flu season. The company is also studying combination respiratory vaccines, although those products would require separate clinical testing and regulatory review.
Postmarketing data will be important
The first two seasons will provide additional information on uptake, safety and effectiveness outside the clinical trial. Those results will help determine how MFlusiva performs across different age groups, risk levels and circulating influenza strains.
Commercial performance will also depend on supply contracts, reimbursement and recommendations from public health authorities. Moderna expects to make the vaccine available for the coming season but has not yet established a long term market share.
Reporting sources
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