US drug regulator to review Moderna's mRNA flu vaccine after rejection

The US Food and Drug Administration (FDA) has agreed to review Moderna's mRNA-based seasonal influenza vaccine after initially refusing to consider the application, the American biotechnology company announced Wednesday.

The FDA's Center for Biologics Evaluation and Research accepted Moderna's amended biologics license application for the vaccine, known as mRNA-1010, setting a target review date of Aug. 5.

The regulator previously rejected the application, saying Moderna's late-stage study did not use the "best-available standard of care" as a comparator, having tested the shot against a standard-dose flu vaccine rather than a more effective alternative.

To address the FDA's concerns, Moderna proposed a revised pathway splitting the application by age group, seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, with a commitment to conduct an additional post-market study in older adults.

If approved, mRNA-1010 would be available for the 2026 - 2027 flu season.

"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," said Moderna Chief Executive Stephane Bancel.

The company added that the vaccine has also been accepted for review in Europe, Canada and Australia, with additional submissions planned later this year.