CHMP Opinion for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster for children 5 through 11 years of age in European Union
Pfizer Inc.and BioNTech SE announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Cominarty Original/Omicron BA.4/BA.5 5/5-µg) has been recommended for marketing authorization by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for children 5 through 11 years of age. The European Commission will review the CHMP recommendation and is expected to make a final decision soon
The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized in the European Union (EU) as a booster dose for individuals aged 12 years and older. Today’s CHMP recommendation to include children 5 through 11 years of age was based on safety and immunogenicity data from the companies’ Omicron BA.1-adapted bivalent vaccine in individuals 12 years and older, data from the initially approved 10-µg pediatric formulation of the companies’ original COVID-19 vaccine, manufacturing data from the companies’ pediatric formulation of the 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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