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Pfizer and BioNTech Advance Next-Generation COVID-19 Vaccine Strategy with Study Start of Candidate Aimed at Enhancing Breadth of T cell Responses and Duration of Protection

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.

Listen Now—The Antigen Season 3 Explores Maternal Immunization

The Antigen, Pfizer’s flagship podcast returns with a three-part mini-series spotlighting maternal immunization. Vaccinations for pregnant people are not new, but they have historically been left out of the vaccine narrative. As maternal immunization is advancing vaccine science and innovation, this series delves into the history, the potential benefits of boosting infant immunity, and the role of maternal antibodies in helping protect infants. We’ll also explore the challenges of maternal immunization and what the future holds.

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19

  • Novel combination vaccination approach aims to help protect individuals against two severe respiratory viral diseases
  • Candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate with the companies’ Omicron-adapted bivalent COVID-19 vaccine based on BA.4/BA.5, each of which is based on BioNTech’s proprietary mRNA platform technology
  • U.S.-based study to include 180 participants 18 to 64 years of age with the first participant dosed this week 

NEW YORK and MAINZ, GERMANY, November 3, 2022

Safety Recommendation on Janus kinase (JAK) Inhibitors Issued in the European Union

New York, October 28, 2022 — Pfizer Inc. (NYSE: PFE) announced today that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded their assessment of Janus kinase (JAK) inhibitors authorized for the treatment of certain inflammatory diseases in the European Union (EU) and has provided updated recommendations for their use.

Advisory Committee on Immunization Practices Recommends Pfizer’s PREVNAR 20® for Adults Previously Vaccinated with PREVNAR 13®

NEW YORK, October 20, 2022 - Pfizer Inc. (NYSE:PFE) today announced that that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend a single dose of PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) to help protect adults previously vaccinated with PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or both PREVNAR 13® and PPSV23 against invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in PREVNAR 20®. 

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union

NEW YORK and MAINZ, Germany, October 19, 2022Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization (MA) for a 3-µg dose of COMIRNATY® (COVID-19 vaccine, mRNA), which is based on the wild-type spike protein of SARS-CoV-2, as a three-dose series for children ages 6 months to less than 5 years (also referred to as 6 months through 4 years of age).

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