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FDA advisory panel backs Moderna flu vaccine candidate for older adults

The backing comes as influenza remains a persistent public health burden

Moderna has received a major regulatory boost after a key advisory panel to the U.S. Food and Drug Administration voted unanimously in favor of its investigational flu vaccine mRNA-1010 for older adults.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9–0 that the benefits of mRNA-1010 outweigh its risks for preventing influenza in adults aged 50 to 64, and again 9–0 for adults 65 and older—signaling strong scientific consensus around the candidate’s risk-benefit profile.

"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."

The backing comes as influenza remains a persistent public health burden, according to the Centers for Disease Control and Prevention, with older adults disproportionately affected by severe outcomes, including hospitalization and death.

VRBPAC’s review drew on Moderna’s Phase 3 clinical program, including pivotal trial data (NCT06602024), previously disclosed in June 2025 and published in the New England Journal of Medicine. The results, regulators noted, support the potential of mRNA-1010 as a non-egg-based alternative for seasonal influenza prevention in older populations.

Safety findings from the Phase 3 program were consistent with earlier studies, reinforcing a tolerability profile in line with prior data on Moderna’s flu vaccine platform.

While the vote marks a significant step forward, the FDA emphasized that advisory committee recommendations are non-binding. Final approval rests with the agency as it continues reviewing Moderna’s Biologics License Application for mRNA-1010.