Moderna’s Vaccine Gets Panel Nod In Adolescents, Older Children; Committee Already Eyes Booster
US FDA advisory committee members debate how a third dose, or booster, of the COVID vaccine should fit into the mix of an EUA expansion for the 12-17 and 6-11 groups; Moderna expects to have immunogenicity and safety data on booster doses in both of age groups by mid-July.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
COVID Vaccines For 5 and Under: Pfizer Pivot To 3 Shots Leaves Meager Data Package Compared To Moderna
Pfizer’s decision to add a third shot to the primary vaccination series for children under five means it didn’t hit FDA’s goal of a median follow-up of two months post-vaccination – at least with blinded data – and the sponsor could only do a preliminary descriptive efficacy analysis since the study had not hit the protocol-specified number of COVID cases.
‘Robust results’ from recent US surveillance studies show slight decreases in the myocarditis risk differential between the Moderna and Pfizer/BioNTech vaccines, agency says in briefing documents for panel review of Moderna’s pediatric EUA request.