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COVID Vaccines For 5 and Under: Pfizer Pivot To 3 Shots Leaves Meager Data Package Compared To Moderna

 
• By Sarah Karlin-Smith

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.

toddlers
FDA vaccine advisors will vote on whether FDA should authorize COVID-19 vaccines for some of the youngest Americans 15 June. • Source: Shutterstock

Pfizer Inc. andBioNTech SE’s COVID-19 vaccine package for the youngest Americans appears to have more data gaps than Moderna, Inc.’s heading into a 15 June advisory committee meeting.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will weigh whether FDA should authorize Pfizer/BioNTech’s three-dose, 3μg shot for children 6 months through 4 years of age

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