FDA approves Pfizer's bivalent COVID-19 booster for young children.

The FDA has authorized a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for children aged 6 months through 4 years who have completed their three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine at least two months ago. The bivalent vaccine includes an mRNA component corresponding to the original virus strain and the omicron variant BA.4 and BA.5 lineages. The authorization is supported by immune response and safety data from clinical studies and postmarketing safety data. Vaccination remains the best defense against severe COVID-19 outcomes, and eligible individuals are encouraged to ensure their vaccinations are up to date with a bivalent COVID-19 vaccine.