Pfizer Inc. and BioNTech SE announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency's Committee for Medicinal Products for Human Use for individuals ages 12 years and older. The European Commission will review the CHMP recommendation and is expected to make a final decision soon. The Omicron BA.4/BA.5-adapted bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants.

Apart from the addition of the mRNA sequence of the BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged. recommendation follows guidance from the EMA, World Health Organization (WHO) and International Coalition of Medicines Regulatory Authorities to advance bivalent vaccine candidates, with the goal of making an Omicron-adapted vaccine available to European Union member states as soon as possible. The CHMP recommendation concerning the Omicron BA.4/BA.5 bivalent COVID-19 vaccine is based on data from Pfizer's and BioNTech's Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from the Omicron BA.4/BA.5-adapted bivalent vaccine.

Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech's Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the ompanies' current COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron sublineages including BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus, while retaining a favorable safety profile. If an authorization is granted, the Pfizer-BioNTech bivalent micron BA.4/BA.5 COVID-19 vaccine will be available within the coming days to all 27 EU member states supporting the European vaccination campaigns.

Local supply may vary based on individual country government requests. In early September, Pfizer and BioNTech were granted aconditional marketing authorization for an Omicron BA.1-adapted bivalent COVID-19 vaccine in the EU. An Omicron-adapted vaccine based on the BA.4/BA.5 subvariant was also authorized by the U.S. Food and Drug Administration as a booster for ages 12 and older on August 31, 2022.

The companies are also planning to file the data with other regulatory authorities in the coming weeks and are planning to submit data to the FDA and the EMA to prepare an application for an Omicron-adapted bivalent vaccine in children younger than 12 years of age. 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 in theUnited 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. Pfizer-BioNTech COVID-19 Vaccine, Bivalent is FDA-authorized underEmergency Use Authorization for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine; or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. AUTHORIZED USES Primary Series athird primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise Pfizer-BioNTech COVID-19 Vaccine INDICATION Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide: AUTHORIZED USES Primary Series a3-dose primary series to individuals 6 months through 4 years of age a2-dose primary series to individuals 5 years through 11 years of age athird primary series dose to individuals 5 years through 11 years of age with certain kinds of immunocompromise Booster a single booster dose to individuals 5 through 11 years of age who have completeda primary series with Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization to prevent Coronavirus Disease 2019 in: individuals 6 months of age and older (Pfizer-BioNTech COVID-19 Vaccine) individuals 12 years of age and older (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) 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.