Agency Reverses Initial Refusal
The U.S. Food and Drug Administration will move forward with reviewing Moderna’s new mRNA-based seasonal flu vaccine after previously declining to accept the company’s application, Moderna announced Wednesday.
Earlier this month, the FDA sent Moderna a letter stating it would not accept the filing for review, citing concerns that the application did not include an “adequate and well-controlled” trial. According to the letter, the control arm of the study did not reflect the “best-available standard of care in the United States at the time of the study.”
The agency did not raise safety or efficacy concerns in its communication, Moderna said.
Revised Regulatory Pathway
Following discussions with regulators, Moderna proposed what it described as a revised regulatory strategy. Under the updated approach, the company is seeking full approval for adults ages 50 to 64 and accelerated approval for adults 65 and older. The accelerated pathway would require a post-marketing study focused on older adults.
The FDA has accepted the amended application. Andrew Nixon, spokesperson for the U.S. Department of Health and Human Services, said in a statement that discussions led to a revised regulatory approach and that the agency “will maintain its high standards during review and potential licensure stages as it does with all products.”
Potential Availability for 2026-2027 Season
If approved, the vaccine could be available for individuals 50 years and older during the 2026-2027 flu season.
Moderna had previously described the FDA’s initial refusal as inconsistent with earlier agency feedback. CEO Stéphane Bancel said the company appreciated the FDA’s engagement during a Type A meeting and its decision to advance the 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,” Bancel said.