FDA authorizes bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for children 6 months through 4 years of age

The FDA has just approved a booster dose of the Pfizer-BioNTech COVID-19 vaccine for children aged 6 months through 4 years. The booster dose must be administered at least 2 months after the competition of the primary vaccination, with 3 doses of the single strain vaccine.

"This is fantastic news," notes Tina Tan, MD, FAAP, FIDSA, FPIDS, editor-in-chief of Contemporary Pediatrics®. "This will allow us to provide optimal protection to the pediatric population aged between 6 months to 4 years against COVID disease and the current subvariants that are circulating."

Children of this age group who received the first 2 doses with the monovalent Pfizer-BioNTech COVID-19 vaccine should have completed their 3-dose primary series with the Pfizer-BioNTech COVID-19 vaccine, bivalent. These children would not be eligible for a booster dose of a bivalent vaccine, as they should already have protection against serious COVID-19 consequences. This authorization is targeted at the children who completed their 3 dose primary vaccination series with the monovalent Pfizer-BioNTech COVID-19 vaccine before the Pfizer-BioNTech COVID-19 vaccine, bivalent was authorized to provide the third dose in the 3-dose primary series.

The FDA decided on this approval from several clinical studies, including one which evaluated primary vaccination with the monovalent Pfizer-BioNTech COVID-19 vaccine in children aged 6 months and older; those which evaluated booster vaccination with monovalent Pfizer-BioNTech COVID-19 vaccine in children aged 5 years and older; a study that looked at a booster dose with Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) in those greater than 55 years of age; and postmarketing safety data with the monovalent Pfizer -BioNTech COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine, bivalent, among other studies. Safety data accrued with the investigational bivalent vaccine and with the monovalent Pfizer-BioNTech COVID-19 vaccine was found to be relevant to the Pfizer-BioNTech COVID-19 vaccine bivalent because the vaccines are created in the same way.

Additionally, the Pfizer-BioNTech COVID-19 vaccine, bivalent includes an mRNA component that corresponds to the original virus strain and provides an immune response that is protective against COVID-19 and an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages. This component provides robust protection against the Omicron variant of COVID-19.

Reference

Coronavirus (COVID-19) update: FDA authorizes bivalent Pfizer-BioNTech COVID-198 vaccine as booster dose for certain children 6 months through 4 years of age. US Food & Drug Administration. March 15, 2023. Accessed March 15, 2023. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-bivalent-pfizer-biontech-covid-19-vaccine-booster-dose?utm_medium=email&utm_source=govdelivery