NEW YORK and MAINZ, GERMANY, November 10, 2022 — Pfizer Inc. PFE and BioNTech SE BNTX announced today a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 5/5-µg) has been recommended for marketing authorization in children aged 5 to 11 years by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The European Commission will examine 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 approved in the European Union (EU) as a booster dose for individuals 12 years of age and older. Today’s CHMP recommendation to include children aged 5 to 11 years was based on safety and immunogenicity data of the companies’ Omicron BA.1-adapted bivalent vaccine in subjects aged 12 years and older, data from the originally approved 10 mcg formulation for Children of the companies’ original COVID-19 vaccine, manufacturing data from the pediatric formulation of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine.
Recently clinical Data from an ongoing phase 2/3 study of the companies BA.4/BA.5-adapted bivalent booster in adults 18 years and older demonstrated a strong immune response against the BA.4 and BA.5 sublines measured over 30 Days after vaccination, with safety and tolerability profile…
