14 March 2023 - Today, the US FDA amended the emergency use authorisation of the Pfizer-BioNTech COVID-19 vaccine, bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 vaccine.

For the authorisation of a single booster dose of the Pfizer COVID-19 vaccine, bivalent for children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent Pfizer-BioNTech COVID-19 vaccine, the FDA evaluated immune response data from 60 children in this age group who had completed primary vaccination with three doses of monovalent Pfizer-BioNTech COVID-19 vaccine and received a booster dose of Pfizer-BioNTech COVID-19 vaccine, bivalent in a clinical study.

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