Pfizer and BioNTech Advance Next-Generation COVID-19 Vaccine Strategy with Study Start of ...

NEW YORK and MAINZ, GERMANY, NOVEMBER 16, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a Phase 1 study to evaluate the safety, tolerability and immunogenicity of a next generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T cell responses and potentially broaden protection against COVID-19. This candidate, BNT162b4, is composed of a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins that are highly conserved across a broad range of SARS-CoV-2 variants and will be evaluated in combination with the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. These non-spike proteins have been chosen based on BioNTech's proprietary target prioritization platform and were designed into a vaccine candidate with the purpose of enhancing and broadening T cell immunity and potentially extending durability of protection against COVID-19.

BNT162b4 will be evaluated in a U.S.-based study ( NCT05541861 ) enrolling approximately 180 healthy individuals between 18 and 55 years of age, who have received at least three doses of an mRNA-based COVID-19 vaccine. The trial will explore different dose levels of BNT162b4 administered in combination with a 30-µg dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and will be compared to the administration of a 30-µg dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a booster.

This study is part of the companies’ long-term and multi-pronged scientific strategy to generate more robust, longer-lasting, and broader immune responses against SARS-CoV-2 infections and associated COVID-19. As part of this approach the companies are developing multiple vaccine candidates with the aim of delivering a potential pan-SARS-CoV-2 vaccine.

The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®) and BNT162b4 are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type 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. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.