FDA Authorizes COVID Bivalent Booster for More Young Children

WASHINGTON — The Food and Drug Administration has amended its emergency use authorization of the Pfizer-BioNTech COVID-19 Bivalent vaccine, authorizing its use as a single booster dose for children 6 months through 4 years who’ve completed their primary vaccinations with the monovalent version.

The agency said in a press release Tuesday that the booster should only be administered two months or more after the individual child has completed a primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.

“Today’s authorization provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a written statement. 

“Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine,” he said.

Children 6 months through 4 years of age who received their first two doses with monovalent Pfizer-BioNTech COVID-19 Vaccine have been eligible to complete their three-dose primary series with the Pfizer-BioNTech COVID-19 Bivalent vaccine since December 2022. 

The agency said 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. 

It goes on to state that the Pfizer-BioNTech COVID-19 Bivalent vaccine includes an mRNA component corresponding to the original virus strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the omicron variants BA.4 and BA.5 to provide better protection against COVID-19 caused by the omicron variant.

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