Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster for children 5 through 11 years of age in European Union

PfizerPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 5/5 µg) has been recommended for marketing authorization by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for children 5 through 11 years of age. 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 COVID-19 vaccine is currently authorized in the European Union (EU) as a booster dose for individuals aged 12 years and older. Today's CHMP recommendation to include children 5 through 11 years of age was based on safety and immunogenicity data from the companies’ Omicron BA.1-adapted bivalent vaccine in individuals 12 years and older, data from the initially approved 10-µg pediatric formulation of the companies’ original COVID-19 vaccine, manufacturing data from the companies’ pediatric formulation of the Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine.

Recent clinical data from an ongoing Phase 2/3 trial of the companies’ BA.4/BA.5-adapted bivalent booster in adults 18 years of age and older demonstrated a strong immune response against the BA.4 and BA.5 sublineages, measured 30 days after immunization, with a safety and tolerability profile is similar to the companies’ original COVID-19 vaccine. In addition to this trial and the already submitted data, a Phase 1/2/3 pediatric study is ongoing that evaluates different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups. Data from both these trials will be shared with regulatory authorities around the world as soon as they become available.

COMIRNATY® and its adapted vaccine variations (COMIRNATY® Original/Omicron BA.1 and COMIRNATY® Original/Omicron BA.4-5) 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.

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.

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.

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