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FDA Approves COVID-19 Bivalent Vaccines for Children and Infants
The U.S. Food and Drug Administration (FDA) has amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age, the agency announced on December 8.
Children 6 months through 5 years of age now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 vaccine 2 months after completing a primary series with the monovalent Moderna COVID-19 vaccine.
Children 6 months through 4 years of age who have not yet begun their 3-dose primary series of the Pfizer-BioNTech COVID-19 vaccine or who have not yet received the third dose of their primary series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following 2 doses of the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine.
However, children 6 months through 4 years of age who have already completed their 3-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant. The data to support giving an updated bivalent booster dose for these children are expected in January.
The Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component corresponding to the original 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. Individuals who receive the updated (bivalent) vaccines may experience similar side effects reported by individuals who received previous doses of the original (monovalent) mRNA COVID-19 vaccines.
The fact sheets for both bivalent COVID-19 vaccines for recipients and caregivers and for health care providers include information about the potential side effects, as well as the risks of myocarditis and pericarditis.
—Rebecca Mashaw
Reference:
Coronavirus (COVID-19) update: FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age. Press release. US Food and Drug Administration. December 8, 2022. Accessed December 9, 2022.
