FDA COVID-19 vaccine update

The US Food and Drug Administration (FDA) yesterday announced it has amended the emergency use authorization (EUA) for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, co-developed by US pharma giant Pfizer (NYSE: PFE) and Germany’s BioNTech (Nasdaq: BNTX), to provide for a single booster dose of the vaccine in children six months through four years of age at least two months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech original COVID-19 vaccine, Comirnaty.

Since December 2022, children six months through four years of age who received the first two doses with monovalent Pfizer-BioNTech COVID-19 Vaccine should have completed their three-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. These children in this age group are not eligible for a booster dose of a bivalent vaccine at this time and are expected to have protection against the most serious COVID-19 outcomes.

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