FDA Reverses Course, Will Review Moderna’s mRNA Flu Vaccine
The U.S. Food and Drug Administration (FDA) has reversed its initial decision and will now review Moderna’s application for its mRNA-based seasonal flu vaccine. This comes after the agency previously refused to accept the application, citing concerns about the clinical trial design.
Initial FDA Concerns and Moderna’s Response
Approximately two weeks ago, the FDA informed Moderna that its application lacked an “adequate and well-controlled” trial. The agency’s concern centered on the control arm of the study, which it determined did not reflect the “best-available standard of care in the United States at the time of the study.” CNN reports that the FDA did not raise any safety or efficacy concerns.
Moderna subsequently met with the FDA and proposed a revised regulatory approach. This new strategy involves different pathways for approval based on age group.
Revised Regulatory Approach
Moderna is now seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older. The accelerated approval pathway for seniors is contingent upon a post-marketing requirement to conduct an additional study specifically focused on this age group. CNN
Potential Availability
If the FDA approves the vaccine, it could be available for individuals aged 50 and older for the 2026-2027 flu season. Moderna CEO Stéphane Bancel expressed appreciation for the FDA’s engagement and stated the company looks forward to making the vaccine available to seniors. CNN
Previous FDA Rejection and Global Interest
The initial refusal from the FDA was described as inconsistent with previous feedback from the agency. CNN. Meanwhile, other countries are moving forward with evaluating Moderna’s mRNA-1010 flu shot, with potential availability in Canada, Europe, and Australia as early as the 2027-2028 flu season. BioSpace
mRNA Technology and Flu Vaccine Efficacy
Moderna executives have emphasized the potential benefits of their mRNA technology in boosting flu shot efficacy, particularly in years with a mismatch between circulating flu strains and those covered by traditional vaccines. BioSpace. The company’s combination flu/COVID shot, mRNA-1083, is also progressing through regulatory bodies in other nations. BioSpace
FDA’s Prior mRNA Vaccine Approval
The FDA has previously authorized and approved Moderna’s mRNA COVID-19 vaccines, including updated, bivalent formulations for all age groups six months and older. FDA