Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to provide a single booster dose of the companies' Omicron BA.4 BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years of age) at least 2 months after completion of primary vaccination with three doses of the Pfizer-BioNTech COVID-19 Original Vaccine. The bivalent vaccine is also authorized in this age group as the third dose of a three dose-primary series for these children, a booster (fourth) dose is not authorized at this time. The EUA is based on data from substudies within the companies' Phase 1 2 3 study (NCT05543616) evaluating the safety, tolerability and immunogenicity of a fourth dose of the bivalent vaccine in children 6 months through 4 years of age (n 300).

Safety and immunogenicity were assessed in a subset of study participants 6 months through 4 years of age (n 60), demonstrating that a booster (fourth) dose of the Omicron BA.4 BA.5-adapted bivalent vaccine elicited improved Omicron BA.4 BA.5-neutralizing antibody responses compared to participants who received three doses of the companies' original vaccine. The safety and tolerability profile of the bivalent vaccine was similar to that of the original vaccine. Pfizer and BioNTech have also submitted an application to the European Medicines Agency (EMA) to extend the Omicron BA.4 BA.5-adapted bivalent vaccine's marketing authorization to include use in children 6 months through 4 years of age as both primary series (all three doses) and booster vaccination (fourth dose).

Currently, the bivalent vaccine is authorized in the European Union (EU) as a booster dose for ages 5 years and older. The companies plan to submit applications to other regulatory authorities worldwide for the use of their Omicron BA.4 BA.5-adapted bivalent vaccine among children under 5 years of age. The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY) are based on BioNTech's proprietary mRNA technology and were developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder for BNT162b2 (Original) and BNT162b2 Bivalent (Original Omicron BA.4 BA.5) 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. COMIRNATY (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4 BA.5) are FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Interchangeability of COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine (Primary Series for Individuals 12 Years of Age and Older) When prepared according to their respective instructions for use, the FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.