FDA Agrees to Review Moderna’s mRNA Flu Vaccine

•? ?The FDA reversed its earlier decision and will review Moderna’s mRNA-based flu vaccine for possible approval.

•? ?Moderna said it split its application by age, seeking traditional approval for adults 50–64 and accelerated approval for those 65 and older.

•? ?The FDA set an August deadline for its decision. If approved, the vaccine could be available for older adults during the upcoming flu season.

•? ?The agency had previously declined the application, citing concerns about the study design and the control vaccine used for participants over 65.