The Food and Drug Administration (FDA) has authorized the use of the bivalent Pfizer-BioNTech COVID-19 vaccine as a booster dose for children 6 months through 4 years of age.
This age group is now eligible to receive the booster dose at least 2 months after they complete primary vaccination with 3 doses of the monovalent Pfizer-BioNTech COVID-19 vaccine. The authorization is supported by previous analyses of the effectiveness of primary and booster vaccination, as well as immune response data from 60 children who had completed primary vaccination with 3 doses of monovalent vaccine and received a booster dose of the bivalent vaccine. Findings showed that these participants demonstrated an immune response to both the original SARS-CoV-2 virus and to Omicron BA.4/BA.5 one month after receiving the booster.
The safety of booster administration in this patient population was based on safety data previously evaluated by the FDA. In individuals 6 months and older, safety was investigated in 2 clinical trials. Among participants 6 months through 23 months, the most common adverse effects following vaccine administration included irritability, drowsiness, injection site redness, pain and swelling, decreased appetite, fatigue, and fever. Among those 2 years through 4 years of age, fatigue, injection site pain, redness and swelling, diarrhea, vomiting, headache, joint pain, and chills were commonly reported.
“Today’s authorization provides parents and caregivers of children 6 months through 4 years of age who received the 3-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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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.”
Children who received the first 2 doses of the monovalent Pfizer-BioNTech COVID-19 vaccine should complete their 3-dose primary series with the bivalent Pfizer-BioNTech COVID-19 vaccine; these children are not eligible for a booster dose of a bivalent vaccine at this time.
The Fact Sheet for Health Care Providers has been updated to reflect these changes.
Coronavirus (COVID-19) Update: FDA authorizes bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age. News release. FDA. March 14, 2023. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-bivalent-pfizer-biontech-covid-19-vaccine-booster-dose.