Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.
On the heels of a Type A meeting with FDA’s Center for Biologics and Research (CBER), Moderna’s seasonal influenza vaccine candidate mRNA-1010 has been officially accepted for formal review.
Moderna announced that CBER is expected to proceed with its biologics license application (BLA) for mRNA-1010 days after issuing the company a prior Refusal-to-File
According to Moderna, the refusal letter identified that the company’s choice of a licensed standard-dose seasonal influenza vaccine as the comparator in its Phase III study was the sole reason the agency refused to file the application.2
In response, FDA cited Moderna was lacking a “adequate and well-controlled” study, due to the company using a comparator that “does not reflect the best-available standard of care.”2
“This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative medicines,” said Stéphane Bancel, chief executive officer of Moderna. “It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting.”
Under the revised proposed approach, Moderna is seeking full approval for adults aged 50 to 64 and accelerated approval for adults 65 and older, alongside a post-marketing commitment to conduct an additional study in the older population.1
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. If approved, mRNA-1010 could be available for U.S. adults aged 50 and older in time for the 2026–2027 influenza season.1
“We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review,” said Stéphane Bancel, chief executive officer of Moderna. “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 has also been accepted for regulatory review in Europe, Canada and Australia, with additional submissions planned in 2026.1
The company says it expects potential approvals to begin in 2026 and will be subject to ongoing reviews.
The vaccine is being evaluated in a Phase III study known as the Glow trial, which enrolled 22,502 adults aged 50 and older between September 2022 and January 2024. The randomized study is assessing the safety and efficacy of the mRNA-based candidate compared with a currently approved seasonal influenza vaccine. Participants received a single injection and were followed for approximately 13 months, including in-person visits and remote safety check-ins.
Seasonal influenza is estimated to cause between 3 million and 5 million cases of severe illness globally each year and up to 650,000 deaths. Effectiveness of currently available flu vaccines varies by season but has typically remained below 60% overall.
