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.