On Sept. 28, 2022, Pfizer and BioNTech announced they had completed a submission to the European Medicines Agency for a 10-ﾵg booster dose of the companiesﾒ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age. This application for a variation of the marketing authorization to include the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group was supported by safety and immunogenicity data from the companies – Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from the companies – 10-ﾵg Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the companies – Omicron BA.4/BA.5-adapted bivalent vaccine.

On September 26, the companies also completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age.

In addition, the companies have also initiated a Phase 1/2/3 study (NCT05543616, C4591048) to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age. This study is consistent with regulatory guidance and follows the design of the previous Phase 1/2/3 trial to evaluate further options for protection in this age group.

COMIRNATY®, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

COMIRNATY® (the Pfizer-BioNTech COVID-19 vaccine) has been granted standard marketing authorization (MA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people aged 5 years and older. The vaccine is administered as a 2-dose series, 3 weeks apart.
Adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose. In addition, the cMA has been expanded to include a booster dose (third dose) at least 3 months after the second dose in individuals 12 years of age and older. A third primary course dose may be administered at least 28 days after the second dose to people aged 5 years and older with a severely weakened immune system. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.