NEW YORK, NY, USA and MAINZ, Germany I November 16, 2022 I 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.
U.S. Indication & Authorized Use
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
AUTHORIZED USE
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA-authorized under Emergency Use Authorization (EUA) for use in individuals 5 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.
*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus
COMIRNATY® (COVID-19 Vaccine, mRNA)
INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved 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.
AUTHORIZED USE
COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA-authorized under Emergency Use Authorization (EUA) to provide:
Primary Series
- a third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise
Pfizer-BioNTech COVID-19 Vaccine
AUTHORIZED USES
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide:
Primary Series
- a 3-dose primary series to individuals 6 months through 4 years of age
- a 2-dose primary series to individuals 5 years of age and older
- a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise
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 (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the 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.
COMIRNATY® Full Prescribing Information and EUA Fact Sheets for Vaccination Providers and Recipients and Caregivers Fact Sheets:
EUA Fact Sheet for Vaccination Providers (12 Years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (5 through 11 Years), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Orange Cap
COMIRNATY® Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
EUA Fact Sheet for Recipients and Caregivers (12 years of age and older)
EUA Fact Sheet for Recipients and Caregivers (5 through 11 years of age)
EUA Fact Sheet for Recipients and Caregivers (6 months through 4 years of age)
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.com.
SOURCE: Pfizer
