FDA authorizes Bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age
March 17, 2023
The U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.
What Parents and Caregivers Need to Know:
- Children 6 months through 4 years of age who completed their three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine more than two months ago are now eligible to receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
- Since December 2022, children 6 months through 4 years of age who receive the first two doses with monovalent Pfizer-BioNTech COVID-19 Vaccine should complete their three-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. These 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. Today’s authorization is for those children 6 months through 4 years of age who completed their 3-dose primary vaccination series with the monovalent Pfizer-BioNTech COVID-19 Vaccine, before the Pfizer-BioNTech COVID-19 Vaccine, Bivalent was authorized to provide the third dose in the 3-dose primary series.
- The Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.
