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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

Pfizer and BioNTech Announce New Agreement with U.S. Government to Provide Additional Doses of COVID-19 Vaccine •105 million 30 µg, 10 µg and 3... | June 30, 2022

105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses Pfizer Inc. (NYSE: PFE) and BioNTech

Omicron-adapted monovalent candidate given as a fourth booster dose elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg dose levels; bivalent

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in