The US Food and Drug Administration (FDA) has reversed its earlier decision and will now review Moderna’s investigational mRNA seasonal influenza vaccine, mRNA-1010, according to an announcement made by Moderna.
The move comes after a rare Refusal-to-File (RTF) letter issued earlier this month, which cited the use of an "inadequate and well-controlled" comparator arm in the pivotal clinical trial.
Following the RTF, Moderna engaged with the FDA’s Center for Biologics Evaluation and Research (CBER) in a Type A meeting, proposing a revised regulatory strategy based on age.
The updated filing seeks full approval for adults aged 50–64 and accelerated approval for adults 65 and older, with a post-marketing commitment to conduct an additional study in the older cohort.
The FDA has accepted the amended Biologics License Application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of 5 August 2026.
If approved, mRNA-1010 could be available for US adults aged 50 and above in time for the 2026/27 flu season.
Moderna’s mRNA-based flu vaccine has shown promise in clinical trials, demonstrating a 26.6% higher efficacy than the comparator flu shot in adults aged 50+.
The platform offers the potential advantage of rapid production and precise strain matching, a significant benefit amid the variability of seasonal influenza.
"We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review," said Moderna CEO Stéphane Bancel.
Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu.
mRNA-1010 is also under regulatory review in Europe, Canada and Australia, with further submissions planned throughout 2026.
Why this matters
The vaccine represents Moderna's first mRNA seasonal influenza candidate and reflects ongoing industry efforts to expand mRNA technology beyond COVID-19 vaccines.
With the FDA review now underway, pharmaceutical manufacturers and vaccine developers will be closely watching the regulatory pathway and potential market entry of mRNA-1010, which could set a precedent for future mRNA-based influenza therapeutics in the US and globally.