FDA, Moderna Align on mRNA Flu Shot for 2 Age Groups Ahead of June 18 Panel
Updated
Updated · BioSpace · Jun 16
FDA, Moderna Align on mRNA Flu Shot for 2 Age Groups Ahead of June 18 Panel
3 articles · Updated · BioSpace · Jun 16
Summary
FDA briefing documents ahead of the June 18 advisory meeting show no major efficacy deficiencies for Moderna’s mRNA-1010 flu shot after the agency initially refused the filing in February.
Moderna is seeking full approval in adults 50–64 and accelerated approval in those 65 and older, with FDA saying the vaccine met prespecified success criteria and showed no major safety imbalances.
The agency still flagged evidence gaps from just 1 flu season and 6 months of follow-up, leaving questions on rare adverse events and on efficacy in immunocompromised and very frail older adults.
Advisers will vote separately on the two age groups; their recommendation is nonbinding, but FDA usually follows it ahead of an August decision date.
For Moderna, the review is pivotal because mRNA-1010 is seen as a potential $1 billion product as the company targets $1.9 billion in 2026 revenue and prepares multiple launches.
With its financial future on the line, can Moderna's new flu shot overcome key safety doubts?
Is a more powerful mRNA flu vaccine worth the risk of new and potentially serious side effects?
FDA Faces Pivotal Decision on Moderna’s mFlusiva: The First mRNA Flu Vaccine for Adults 50+ Amid Regulatory and Public Scrutiny
Overview
Moderna's mFlusiva mRNA flu vaccine faces a pivotal moment as the FDA's advisory committee, VRBPAC, meets on June 18, 2026, to decide if its benefits outweigh the risks for adults aged 50 and older. The FDA often follows the committee's advice, though it is not required to do so. Earlier, the FDA issued a 'refuse-to-file' letter due to concerns about the trial design for those 65 and older, specifically because the control group received a standard-dose vaccine instead of the CDC-preferred high-dose. After Moderna addressed these concerns, the application moved forward, setting the stage for this crucial decision.