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U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

  • Pfizer oral treatment remains available to eligible U.S. patients under Emergency Use Authorization as a critical tool in the fight against COVID-19

NEW YORK, December 20, 2022 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

NEW YORK, December 13, 2022 -- Pfizer Inc. (NYSE: PFE) has reached an agreement with the U.S. Government for the purchase of an additional 3.7 million treatment courses of its authorized COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). This purchase supplements the 20 million treatment courses previously contracted by and already delivered to the U.S. Government. The additional 3.7 million treatment courses are planned for delivery by early 2023. 

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

NEW YORK and MAINZ, GERMANY, DECEMBER 9, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection.

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

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