Pfizer’s COVID-19 Vaccine Data In Young Children Could Place US FDA In Awkward Position Again
The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.
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The unblinding process began months before a third dose was added to the study in the 6 months-4 years group. Consequently, only about one-third of vaccine recipients in each age cohort received three doses of BNT162b2.
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.
FDA praised for pulling back on plans to host 15 February advisory committee review of Pfizer’s COVID-19 vaccine in children but faulted, along with other parts of US government, for raising expectations this month that the vaccine might be available for this population imminently.