Pfizer: Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. This application for a variation of the conditional marketing authorization (cMA) follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work towards introducing Omicron-adapted bivalent vaccines.

The bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike-protein of SARS-CoV-2, which is present in COMIRNATY® (the original Pfizer-BioNTech COVID-19 Vaccine) and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 variants. With the exception of the addition to the mRNA of the Omicron BA.4/BA.5 spike protein sequence, all other components of the vaccine remain unchanged. Pre-clinical data showed a booster dose of Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain.

In addition to the pre-clinical, quality and manufacturing data for the Omicron BA.4/BA.5 adapted bivalent vaccine, the submission is supported by safety, tolerability and immunogenicity data from a Phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine, which combines 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2 with 15-µg of mRNA encoding the spike protein of the Omicron BA.1 variant. The companies have also provided safety data from clinical trials evaluating multiple variant-adapted vaccine candidates based on previous variants of concern (e.g., Alpha, Beta and Delta variants).

Pfizer and BioNTech also filed an application with the EMA for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July which is currently under review by the Agency. Both the Omicron BA.1-adapted and Omicron BA.4/BA.5-adapted bivalent boosters will be available to ship shortly after respective regulatory authorizations and be available for use as early as September, pending regulatory approval. Local supply may vary based on individual country government requests.

On August 22, 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 individuals 12 years of age and older.

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.