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FDA approves Bivalent COVID-19 Vaccines for children 6 months of age

Children Vaccinations
Posted at 10:24 AM, Dec 08, 2022
and last updated 2022-12-08 10:24:23-05

(WXYZ) — The U.S. Food and Drug Administration has amended emergency use authorizations for the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children as young as 6 months.

Children ages 6 months through 5 years old who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 Vaccine two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine.

Children ages 6 months through 4 who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine or 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 two doses of the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine.

Children in that same age range who have already completed their three-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.

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so, especially as we head into the holidays and winter months where more time will be spent indoors,” FDA Commissioner Robert M. Califf, M.D. said. 

The Moderna COVID-19 Vaccine, Bivalent is now authorized for administration in individuals 6 months through 5 years of age as a single booster dose at least 2 months after completion of primary vaccination with the monovalent Moderna COVID-19 Vaccine.

The Moderna COVID-19 Vaccine, Bivalent is also authorized for use in individuals 6 years and older as a single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine, or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.