Pharma Focus Asia

Pfizer and BioNTech Receive U.S. Emergency Use Authorisation of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster

Wednesday, March 15, 2023

Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) granted emergency use authorisation (EUA) to provide a single booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years of age) at least 2 months after completion of primary vaccination with three doses of the Pfizer-BioNTech COVID-19 Original Vaccine. The bivalent vaccine is also authorized in this age group as the third dose of a three dose-primary series; for these children, a booster (fourth) dose is not authorised at this time.

Based on the latest real-world evidence, Omicron BA.4/BA.5-adapted bivalent vaccines appear to be protective against symptomatic COVID-19 disease in adults caused by both BA.4/BA.5 and XBB Omicron sublineages,2 the latter of which currently account for more than 85% of COVID-19 cases in the U.S.

Pfizer and BioNTech have also submitted an application to the European Medicines Agency (EMA) to extend the Omicron BA.4/BA.5-adapted bivalent vaccine’s marketing authorisation to include use in children 6 months through 4 years of age as both primary series (all three doses) and booster vaccination (fourth dose). Currently, the bivalent vaccine is authorised in the European Union (EU) as a booster dose for ages 5 years and older.

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