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.