• Read more about First Participant Dosed in Phase 2/3 Study of Oral Antiviral Candidate in Non-Hospitalized Adults with COVID-19 Who Are at Low Risk of Severe Illness

New York, N.Y., September 1, 2021 – Pfizer Inc. (NYSE:PFE) today shared that the first participant has been dosed in a pivotal Phase 2/3 clinical trial to evaluate the safety and efficacy of PF-07321332 – an investigational orally administered protease inhibitor antiviral therapy designed specifically to combat COVID-19 – in non-hospitalized, symptomatic adult participants who have a confirmed diagnosis of SARS-CoV-2 infection and are not at increased risk of progressing to severe illness, which may lea

• Read more about Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX® (varenicline) Tablets Due to N-Nitroso Varenicline Content

FOR IMMEDIATE RELEASE - NEW YORK, NY., August 13, 2021.

Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

• Read more about First Participant Dosed in Phase 2/3 Study of Oral Antiviral Candidate in Non-Hospitalized Adults with COVID-19 Who Are at Low Risk of Severe Illness

New York, N.Y., September 1, 2021 – Pfizer Inc. (NYSE:PFE) today shared that the first participant has been dosed in a pivotal Phase 2/3 clinical trial to evaluate the safety and efficacy of PF-07321332 – an investigational orally administered protease inhibitor antiviral therapy designed specifically to combat COVID-19 – in non-hospitalized, symptomatic adult participants who have a confirmed diagnosis of SARS-CoV-2 infection and are not at increased risk of progressing to severe illness, which may lea

• Read more about FDA Issues Drug Safety Communication Related to Current XELJANZ® Label

New York, September 1, 2021 — The U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication (DSC) related to XELJANZ^® /XELJANZ XR^® (tofacitinib) and two other arthritis medicines in the same drug class, based on its completed review of the ORAL Surveillance trial.

• Read more about The Bristol-Myers Squibb-Pfizer Alliance is pleased with the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis®Patents

Princeton, N.J. & New York, September 3, 2021 — The Bristol-Myers Squibb-Pfizer Alliance today issued the following statement:

• Read more about Pfizer and BioNTech Submit a Variation to EMA with the Data in Support of a Booster Dose of COMIRNATY®

NEW YORK and MAINZ, GERMANY, September 6, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY^® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.

• Read more about Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (varenicline) Tablets Due to N-Nitroso Varenicline Content

FOR IMMEDIATE RELEASE - NEW YORK, NY., September 16, 2021 - Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure.

• Read more about Pfizer and BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union

NEW YORK and MAINZ, Germany, October 4, 2021—Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech  SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older.

• Read more about Important Update on EpiPen® (epinephrine injection, USP) 0.3 mg Auto-Injectors

Extended Expiration Dates for Select Lots of EpiPen® 0.3 mg Auto-Injectors and Its Authorized Generic

To address shortages of EpiPen, Pfizer is coordinating with FDA to extend the expiration dates of specific lots of EpiPen® 0.3 mg Auto-Injectors and its authorized generic version after review of stability data. Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth-quarter of 2018.

• Read more about FDA Issues Update to XELJANZ® Prescribing Information in the United States

New York, December 3, 2021 — Pfizer Inc. (NYSE: PFE) announced today that the U.S. Prescribing Information for XELJANZ® /XELJANZ XR/XELJANZ Oral Solution (tofacitinib) has been revised; updates include a new boxed warning for major adverse cardiovascular events (MACE) and updated boxed warnings regarding mortality, malignancies and thrombosis (with corresponding updates to applicable warnings and precautions).