An advisory panel to the federal government has recommended approval for Moderna’s mRNA influenza vaccine, intended for older adults.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to endorse the investigational vaccine, known as mRNA-1010 and to be marketed as mFlusiva, for preventing the flu in adults aged 50 to 64. The committee also supported its accelerated approval for individuals 65 and older, contingent upon Moderna conducting a post-marketing study to confirm its effectiveness in this age group.
This recommendation follows a period of evolving regulatory consideration. Initially, the FDA had indicated it would review Moderna’s application but later reversed that decision, citing concerns that the phase 3 trial’s comparator vaccine (a standard-dose seasonal flu shot) was not adequate. Moderna stated that the FDA had previously agreed to this comparator.
Concerns were raised about potential shifts in regulatory standards, particularly in light of public criticisms of mRNA vaccines by the Secretary of Health and Human Services. However, the FDA subsequently reconsidered its position and agreed to review the application, proposing the current dual approach for full and accelerated approval with post-market surveillance for the older demographic.
The VRBPAC’s decision was based on data from a phase 3 trial involving nearly 41,000 adults aged 50 and over across 11 countries during the 2024-25 flu season. The trial indicated that mRNA-1010 provided significantly better protection against flu-like illness compared to standard-dose vaccines, demonstrating a relative vaccine efficacy of 27%. Immunogenicity data also suggested efficacy in those aged 65 and above.
Panel members were tasked with assessing whether the benefits of mFlusiva outweighed the risks for both age groups. Despite discussions regarding the trial’s single-season duration, limited data on immunocompromised or very frail older adults, and a slightly higher incidence of primarily fever-related side effects with mRNA-1010, all nine committee members voted in favor of recommendation for both age categories.
Moderna expressed enthusiasm for the panel’s recommendation, highlighting the vaccine’s potential as a new option for flu prevention and showcasing the adaptability of their mRNA technology. The company anticipates it could be more rapidly updated to match evolving flu strains.
The recommendation will now be reviewed by the FDA, which is expected to make a final decision by August 5.
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