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Pfizer and BioNTech seek FDA authorisation for COVID-19 booster for children

September 27, 2022


The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein – present in the original Pfizer/BioNTech COVID-19 vaccine – together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant.

A 30µg booster dose has already been granted EUA by the FDA for individuals 12 years and older, and has also been recommended for Conditional Marketing Authorisation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the same age group.

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