Pfizer-BioNTech COVID-19 Vaccine Booster Dose for Children 5-11 Years
On May 17, 2022, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. This amendment authorizes administration of a single booster dose to children ages 5 through 11 years old after completion of a primary series with the Pfizer-BioNTech COVID-19 vaccine. On May 19, 2022, the Advisory Committee on Immunization Practices (ACIP) met and voted to approve a recommendation stating, “A single Pfizer-BioNTech COVID-19 vaccine booster dose is recommended for persons ages 5-11 years at least 5 months after the primary series, under the FDA’s Emergency Use Authorization.”
This technical bulletin summarizes the recent Pfizer-BioNTech COVID-19 vaccine booster dose recommendation for children. Children eligible to receive the recommended Pfizer-BioNTech COVID-19 vaccine booster dose include:
- Any individual ages 5 through 11 years old, at least five months after completion of a two-dose Pfizer-BioNTech COVID-19 vaccine primary series; and
- Any moderately to severely immunocompromised individual ages 5-11 years old, at least three months after completion of a three dose Pfizer-BioNTech COVID-19 vaccine primary series.
According to the FDA news release, the Omicron strain of COVID-19 is impacting children more than previous COVID-19 variants. This impact can be seen in higher incidence and hospitalization and longer-term effects in children who become sick with COVID-19 according to data on the CDC COVID tracker website. The Vaccine Information Fact Sheets for Recipients and/or Caregivers and Healthcare Providers have also been updated by the FDA for reference.
The Western States Scientific Safety Review Workgroup discussed data presented at the May 19, 2022, ACIP meeting and concluded that “the available data supported the conclusion that the benefits of giving a booster dose of the Pfizer BioNTech COVID-19 vaccine to those 5-11 years of age substantially outweigh the risks, particularly in light of data presented to ACIP concerning the significant but often underappreciated burden of COVID-19-related illnesses, hospitalizations, and deaths in children in this age group.”
It is important to note the primary goal of the COVID-19 vaccine response should continue to be COVID-19 vaccine administration to the unvaccinated.