The Food and Drug Administration (FDA) has revised the Emergency Use Authorizations (EUAs) for the updated bivalent formulations of the Moderna and Pfizer-BioNTech COVID-19 Vaccines to include use in children 6 months of age and older.

The bivalent formulations contain the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant. The bivalent vaccines were previously authorized for use as a booster dose in adults and children 5 years of age and older.

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


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The authorization was based on previous immune response data from a clinical study in adults 18 years of age and older who received a booster dose of Moderna’s investigational bivalent COVID-19 vaccine (original and Omicron BA.1). Moreover, the FDA conducted an analysis of data from a clinical study that showed the immune response to the booster dose of the monovalent Moderna COVID-19 Vaccine in individuals 17 months through 5 years of age was comparable to that seen with the 2-dose primary series in adult participants.

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is now authorized for use in children 6 months through 4 years of age as the third dose of the 3-dose primary series following 2 doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine. With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use as the third dose of the 3-dose primary series in this age group.

The authorization was based on previous analyses of primary vaccination with the monovalent Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older and individuals 6 months through 4 years of age, as well as an analysis of immune response in adults 55 years of age and older who received a 2-dose primary series and 1 booster dose with the monovalent vaccine and a second booster dose with the investigational bivalent vaccine (original and Omicron BA.1).

According to the FDA, children 6 months through 4 years of age who have already completed the 3-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of the updated bivalent vaccine at this time. Data to support use of the bivalent booster in these children are expected in January.

Side effects from the bivalent vaccines are expected to be similar to those reported with the monovalent vaccines.

“Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”

Reference

Coronavirus (COVID-19) update: FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age. News release. US Food and Drug Administration. Accessed December 8, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-updated-bivalent-covid-19-vaccines-children-down-6-months.

This article originally appeared on MPR