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FDA Expands Authorization of Bivalent COVID-19 Vaccines to Young Children

December 12, 2022

The FDA has updated its Emergency Use Authorizations (EUA) for the Pfizer-BioNTech and Moderna bivalent COVID-19 vaccines to include children as young as six months old.

Children between six months and four years old who have not received their Pfizer-BioNTech three-dose primary COVID-19 vaccine series can receive the bivalent shot as the third dose, the agency said.

For the Moderna option, children between six months and five years old who received the original monovalent Moderna COVID-19 vaccine can receive a single bivalent booster dose two months after completing the primary series.

“The more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations and deaths,” said FDA Commissioner Robert Califf.

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