Pfizer Inc. and BioNTech SE announced they have completeda submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies' bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies' 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies' Omicron BA.4/BA.5-adapted vaccine in their decision. An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization to include children ages 5 through 11 years will be submitted to the European Medicines Agency (EMA) in the coming days.

The companies have also initiated a Phase 1/2/3 study NCT05543616 [1] (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 pediatric study is consistent with regulatory guidance and follows aprevious [2] Phase 1/2/3 trial involving these age groups that demonstrated the original Pfizer-BioNTech COVID-19 Vaccine is well-tolerated and offersa high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent. The Pfizer-BioNTech COVID-19 Vaccine, 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. About the Study: The Phase 1/2/3 pediatric clinical study will have four substudies examining different bivalent vaccine dosing regimens, dose levels and ages, including: Substudy A (Ages 6 through 23 months who are COVID-19 vaccine-naïve): Phase 1 dose-finding study will evaluate 3-µg, 6-µg, and 10-µg dose levels of the bivalent vaccine.

Based on Phase 1, Participants in the Phase 2/3 will receive the selected dose as a three-dose primary series, followed by a booster dose. Substudy B (Ages 6 months through 4 years who had previously received2-3 doses of original COVID-19 vaccine): Those who have received two doses of the original COVID-19 vaccine prior to enrollment will receive both athird and fourth3-µg dose of the bivalent vaccine. Those who have previously received three doses of the original vaccine will receivea3-µg booster (fourth) dose of the bivalent vaccine.

Substudy C (Ages 6 months through 4 years who had previously received3 doses of original COVID-19 vaccine): Phase 1 dose-finding study will evaluate 6-µg and 10-µg dose levels of the bivalent vaccine for afourth dose. Based on Phase 1, Phase 2/3 will receive the selected dose as afourth dose. Substudy D (Ages 5 through 11 years who had previously received2-3 doses of original COVID-19 vaccine): Participants will receive the bivalent vaccine as either athird or fourth 10-µg booster dose.