FDA authorizes updated bivalent COVID vaccines for children down to 6 months of age

On December 8, 2022, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) to include updated COVID-19 bivalent vaccines for children six months to five years of age. FDA's news release include the following information:

• Children 6 months through five years of age who received the original (monovalent) Moderna COVID-19 Vaccine are 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.
• With this December 8, 2022 action, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use as the third dose of the three-dose primary series in children 6 months through 4 years of age. The monovalent Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration as the first two doses of the three-dose primary series in individuals 6 months through 4 years of age, as a two-dose primary series for individuals 5 years of age and older, and as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise.
• Children 6 months through 4 years of age 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 6 months through 4 years of age 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. 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 agency is committed to evaluating the data as quickly as possible.

Updated FDA resources for 6 months through 5 years of age COVID-19 bivalent vaccines:

• Fact Sheet for Healthcare Providers Administering Vaccine, Moderna COVID-19 Vaccine Bivalent
• Moderna Dear Healthcare Provider Letter
• Fact Sheet for Healthcare Providers Administering Vaccine, Pfizer COVID-19 Vaccine
• Pfizer Dear Healthcare Provider Letter, change in third dose of 3-dose primary series

The DOH COVID-19 Vaccine Program will reach out to vaccine providers with additional details.