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Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years NEW YORK and... | March 1, 2023
CHMP recommendation based on favorable data from Omicron-adapted vaccines The Omicron BA.4/BA.5 bivalent COVID-19 booster vaccine combines 15-ug of mRNA encoding the wild-type spike protein
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine The Omicron BA.1-adapted bivalent COVID-19 vaccine
Authorization based on clinical, pre-clinical and manufacturing data for Omicron-adapted bivalent vaccines Pfizer-BioNTech Omicron BA.4/BA.5 Bivalent Vaccine combines 15-g of mRNA encoding
Updated analysis from 34 cases occurring at least seven days following a three-dose regimen showed 73.2% vaccine efficacy among children ages 6 months through 4 years The vaccine efficacy