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Pfizer to Acquire Sanford, North Carolina Manufacturing Site from Abzena

NEW YORK & SAN DIEGO, January 17, 2023 – Pfizer Inc. (NYSE: PFE) and Abzena today announced that the companies have entered into an agreement under which Pfizer will acquire Abzena’s manufacturing facility in Sanford, North Carolina. Upon completion of the construction, the state-of-the-art facility will have extensive capabilities for producing biologics drug substance and provides additional manufacturing capacity allowing Pfizer to help accelerate its innovative pipeline. In addition, Abzena and Pfizer’s CentreOne contract manufacturing organization will seek to collaborate to advance complex biologic products to market.

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 SEextlink label (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.
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