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Moderna says the U.S. Food and Drug Administration (FDA) has agreed to review its influenza vaccine, reversing an earlier decision to reject the application, after the company made modifications.
The reversal announced Wednesday comes just a week after the FDA’s surprise decision to not review the company’s experimental flu vaccine application.
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 health policy under U.S. Health Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist who has been particularly critical of mRNA vaccines.
U.S. Health Secretary Robert F. Kennedy Jr. has cancelled $500 million in funding for the development of mNRA vaccine technology. For The National, CBC’s Heather Hiscox asks infectious disease specialist Dr. Allison McGeer and health researcher Bradley Wouters to break down what kind of impact this could have on fighting disease in Canada and around the world.
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 Aug. 5.
Health Canada said it accepted Moderna’s mRNA influenza vaccine for review on Jan. 28, 2026, “with a decision anticipated within the standard review timeline of 300 days” after acceptance.
Moderna said it has also applied for the vaccine’s approval in Europe and Australia.