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.