Pfizer and BioNTech have completed a submission to the Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for a 10-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children 5 to 11 years of age.

In August 2022, the FDA authorized the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for use as a single booster dose in individuals 12 years of age and older, at least 2 months following the primary or booster vaccination, with any authorized or approved monovalent COVID-19 vaccine.

The bivalent vaccine contains 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 EUA submission is supported by safety and immunogenicity data from the Companies’ bivalent Omicron BA.1-adapted vaccine as well as preclinical data from the Omicron BA.4/BA.5-adapted vaccine.

Additionally, a phase 1/2/3 study (ClinicalTrials.gov Identifier: NCT05543616) is evaluating the safety, tolerability, and immunogenicity of different doses and dosing regimens of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age. This pediatric study is consistent with regulatory guidance and follows the previous phase 1/2/3 trial which showed that the original Pfizer-BioNTech COVID-19 vaccine was well tolerated with a high immune response against COVID-19 in this age population.

Reference

Pfizer and BioNTech submit application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster in children 5 through 11 years of age. News release. Pfizer Inc. and BioNTech SE. Accessed September 26, 2022. https://www.businesswire.com/news/home/20220923005307/en/Pfizer-and-BioNTech-Submit-Application-to-U.S.-FDA-for-Emergency-Use-Authorization-of-Omicron-BA.4BA.5-Adapted-Bivalent-Vaccine-Booster-in-Children-5-Through-11-Years-of-Age