FDA de­lays Mod­er­na RSV vac­cine de­ci­sion, but what's next is like­ly to be a tougher, longer climb

The FDA has de­layed the PDU­FA date for Mod­er­na’s RSV vac­cine, the com­pa­ny an­nounced Fri­day morn­ing.

The de­lay like­ly won’t push the de­ci­sion past the end of May, ac­cord­ing to Mod­er­na’s press re­lease, and reg­u­la­tors have not raised any con­cerns about “vac­cine safe­ty, ef­fi­ca­cy or qual­i­ty” pre­vent­ing the shot’s ap­proval. Rather, the FDA cit­ed “ad­min­is­tra­tive con­straints” for the de­lay, and the shot is still on track to be re­viewed at the CDC’s June ACIP meet­ing, when the agency will make its rec­om­men­da­tions for the up­com­ing RSV vac­cine sea­son.

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