The Moderna Inc. headquarters in Cambridge, Massachusetts, on March 26, 2024.
Adam Glanzman | Bloomberg | Getty Images
Moderna said on Wednesday the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application, after the company made modifications.
The reversal, which comes just a week after the FDA’s surprise decision to not review the company’s experimental flu vaccine application, lifted shares of the vaccine maker more than 3% before the bell.
The FDA has accepted Moderna’s revised approach seeking full approval for the shot for adults aged between 50 and 64, and accelerated approval for those aged 65 and above, the company said, adding that it will also conduct a post-marketing study in older adults.
The mRNA technology used in Moderna’s and most other COVID-19 shots, credited with saving millions of lives, comes with a shift in the national health policy under U.S. Health Secretary Robert F. Kennedy Jr., a long-time anti-vaccine activist who has been particularly critical of mRNA vaccines. The regulator had defended its initial decision, saying the company should have given a higher-strength vaccine to older patients in the control arm of its trial.
“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,” Moderna CEO Stéphane Bancel said.
The regulator is expected to make a decision on the candidate by August 5.