• Read more about Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates

Media Contact:
Media Relations
+1-212-733-1226
[email protected]

FOR IMMEDIATE RELEASE - December 22, 2022 - NEW YORK, NY.,

• Read more about 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).

• Read more about 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. 

• Read more about 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.

• Read more about Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

•    New agreement to supply up to 3.4 million treatment courses to countries across Europe; this deal supplements the courses provided to 17 EU member states under existing bilateral agreements 

•    Deliveries to participating countries commencing imminently 

• Read more about 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

• Read more about 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

• Read more about 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.

• Read more about 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®. 

• Read more about 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, 2022 — Pfizer 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).