Moderna’s mRNA-1010 flu vaccine BLA accepted by FDA after RTF resolution; PDUFA target August 5, 2026, for adults 50+. Accelerated path for seniors eyes 2026/27 season launch. Reviews underway in EU, Canada, Australia.
Written By: Pharmacally Medical News Desk
Moderna, Inc. has made significant strides in its seasonal influenza vaccine candidate, mRNA-1010, following a collaborative engagement with the U.S. Food and Drug Administration (FDA).
In response to an earlier Refusal-to-File (RTF) letter, the company held a Type A meeting with the FDA and proposed a tailored regulatory pathway. This approach seeks full approval for adults aged 50 to 64, alongside accelerated approval for those 65 and older.
To support the latter, Moderna committed to a post-marketing study in older adults, addressing key efficacy data needs.
The FDA has now accepted the amended Biologics License Application (BLA) for review, setting a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026.
If approved, mRNA-1010 could launch for U.S. adults 50 and older ahead of the 2026/2027 flu season, offering a novel mRNA-based option to combat seasonal influenza.
Stéphane Bancel, Moderna’s CEO, highlighted the partnership: “We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review. 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.”
This milestone extends beyond the U.S. mRNA-1010’s BLA is under review in Europe, Canada, and Australia, with additional submissions planned for 2026. Moderna anticipates first approvals this year, pending regulatory outcomes.
The vaccine leverages Moderna’s proven mRNA platform pioneered with its COVID-19 vaccine to potentially deliver stronger, more adaptable protection against evolving flu strains, particularly vital for vulnerable seniors.
Earlier this year, an unexpected RTF letter from the FDA’s Center for Biologics Evaluation and Research (CBER) halted Moderna’s original BLA filing for mRNA-1010, sparking significant chaos and disappointment within the company. Moderna stood firmly behind its comprehensive dataset from Phase 3 trials, which demonstrated strong immunogenicity across age groups. CBER’s primary concern was that the application did not include an “adequate and well-controlled” study with a comparator reflecting the best-available standard of care.
Through a swift Type A meeting, Moderna addressed CBER’s concern; full approval for 50-64-year-olds based on existing Phase 3 immunogenicity data, and accelerated approval for those 65+ supported by post-marketing commitments paving a constructive path forward and restoring regulatory momentum.
Reference
Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission, 18 February 2026, News Release
FDA Issues Refusal-to-File Letter for Moderna’s mRNA-1010 Flu Vaccine, 11 February 2026, https://pharmacally.com/fda-issues-refusal-to-file-letter-for-modernas-mrna-1010-flu-vaccine/