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.
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...