Pfizer, BioNTech complete submission to EMA for Omicron BA.4/BA.5-Adapted Bivalent vaccine booster in children aged 5 Through 11 years
COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.
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New York: Pfizer Inc. and BioNTech SE have announced that they have completed a submission to the European Medicines Agency (EMA) for a 10-µg booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age.
This application for a variation of the marketing authorization (MA) to include the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies' Omicron BA.1-adapted bivalent vaccine, non clinical and manufacturing data from the companies' 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the companies' Omicron BA.4/BA.5-adapted bivalent vaccine.
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