CDC Greenlights Pfizer-BioNTech mRNA Booster Dose for Children Aged 5 to 11 Years on Limited Evidence

The Centers for Disease Control and Prevention (CDC) convened the meeting of their Advisory Committee on Immunization Practices (ACIP) after an Emergency Use Authorization (EUA) amendment issued by the U.S Food and Drug Administration (FDA) on May 17 expanding the eligibility for the Pfizer-BioNTech COVID-19 vaccine booster dose for children ages 5 to 11 years at least five months after completion of a primary series. Responding to the policy question posed by CDC, and “based on the balance of benefits and risks,” ACIP voted in favor of the following Interim Recommendation: “A single Pfizer-BioNTech COVID-19 vaccine booter dose is recommended for persons ages 5-11 years at least 5 months after the primary series, under the FDA’s Emergency Use Authorization.”

The FDA’s decision was based on data generated in a subset of children participating in the same clinical trial (C4591007) that supported the original EUA for a primary series in this age group in October 2021. For the evaluation of safety, 401 children were followed for 1 month after a booster (3rd) dose was given at least five months (range 5 to 9 months) after completing a two-dose primary series.

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