The US Food and Drug Administration (FDA) has authorized 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. These participants demonstrated an immune response to both the original SARS-CoV-2 virus and to BA.4/BA.5 one month after receiving the booster.
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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.
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.
Reference
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.
This article originally appeared on MPR
