Moderna has revealed that the FDA will assess its influenza vaccine after the company made adjustments, reversing a previous decision to deny the application. This turnaround, announced on Wednesday, follows the FDA’s unexpected move to not review Moderna’s experimental flu vaccine application just a week prior.
The FDA has now accepted Moderna’s modified approach, aiming for full approval for the vaccine for individuals aged 50-64, and accelerated approval for those 65 and older. Additionally, the company will conduct a post-marketing study among older adults.
Utilizing mRNA technology found in Moderna’s COVID-19 vaccines, which has been lauded for saving countless lives, there has been a shift in health policy under U.S. Health Secretary Robert F. Kennedy Jr., a prominent anti-vaccine activist critical of mRNA vaccines.
The FDA had initially defended its decision, stating that Moderna should have provided a stronger vaccine to older patients in the trial’s control group. Moderna’s CEO, Stéphane Bancel, expressed eagerness to offer the flu vaccine later this year pending FDA approval.
A decision on the vaccine candidate is expected by August 5. Furthermore, Health Canada confirmed the acceptance of Moderna’s mRNA influenza vaccine for review on January 28, 2026, with a decision anticipated within the standard 300-day review timeline post-acceptance.
Moderna has also sought approval for the vaccine in Europe and Australia.