• Read more about U.S. FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine

NEW YORK AND MAINZ, GERMANY, JULY 16, 2021—Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

• Read more about Pfizer Issues A Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (varenicline) Tablets Due to N-Nitroso Varenicline Content

FOR IMMEDIATE RELEASE - NEW YORK, NY., July 16, 2021.

Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 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 Pfizer and BioNTech Share Detailed Update to the Results from 6 Month Safety and Efficacy Data Analysis of Landmark COVID-19 Vaccine Study

NEW YORK AND MAINZ, GERMANY, JULY 28, 2021—Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today shared the detailed six-month follow-up results from the Landmark Phase 3 study of the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) on the preprint server medRxiv and have submitted the manuscript to a peer-reviewed publication.

• 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 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.