FDA Authorizes COVID Bivalent Booster for More Young Children

March 15, 2023 by Dan McCue
FDA Authorizes COVID Bivalent Booster for More Young Children
COVID vaccine (Photo by Dan McCue)

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.

Dan can be reached at [email protected] and @DanMcCue

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