Moderna announces unanimous FDA advisory committee vote in favour of the benefit-risk profile of mRNA-1010, an investigational seasonal influenza vaccine

Moderna has announced that the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee returned a unanimous 9-0 vote confirming that the benefits of mRNA-1010, its investigational seasonal influenza vaccine, outweigh its risks for influenza prevention in adults aged 50 through 64, and a further 9-0 vote reaching the same conclusion for adults aged 65 and above.

“We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Influenza continues to cause substantial illness and hospitalizations among older adults each year. We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform. We look forward to continuing to work with the FDA as it completes its review.”

Seasonal influenza continues to represent a meaningful public health challenge, with older adults bearing a disproportionate share of serious outcomes including hospitalisations and deaths, according to the US Centers for Disease Control and Prevention.

The advisory committee’s deliberations drew on data from Moderna’s Phase 3 clinical programme, including primary analysis results from the pivotal Phase 3 trial, which were first shared in June 2025 and have since been published in The New England Journal of Medicine. These findings add further weight to the case for mRNA-1010 as a differentiated, non-egg-based option for protecting older adults against influenza.

Throughout the Phase 3 programme, the safety profile of mRNA-1010 remained consistent with findings from earlier studies of Moderna’s influenza vaccine candidate.

The FDA will weigh the advisory committee’s recommendations as it progresses its review of Moderna’s Biologics License Application for mRNA-1010, though it bears noting that such recommendations are non-binding and the final approval decision rests entirely with the agency.

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influenza vaccine, Moderna, vaccine