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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.

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

NEW YORK and MAINZ, Germany, October 4, 2021Pfizer 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.

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.

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).

Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of COMIRNATY® in Adolescents 12 Through 15 Years of Age

NEW YORK and MAINZ, GERMANY, December 16, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. 

Pfizer and BioNTech to Provide European Union More Than 200 Million Additional Doses of COMIRNATY® to Help Meet Continued Need for Vaccine Supply

  • European Commission exercise part of its option for over 200 million additional doses to be delivered in 2022
  • These doses are in addition to the 450 million doses already planned for delivery in 2022, bringing the total number of vaccine doses in the European Union to more than 650 million

NEW YORK AND MAINZ, GERMANY, DECEMBER 20, 2021—Pfizer Inc.

Pfizer Statement on Results of Third Annual Pay Equity Study Among Colleagues Worldwide

NEW YORK, N.Y., February 22, 2022Pfizer Inc. (NYSE:PFE) stated today that, for the third year in a row, a recognized compensation expert confirmed equitable pay practices for employees at Pfizer.

The study assessed pay for gender worldwide and for minorities in the United States based on compensation data, including base pay, merit increases and bonuses. The study measured the difference between similar groups of employees when adjusting for factors such as role, grade, job level, experience, and location.

CDC Advisory Committee on Immunization Practices Votes to Recommend TicoVac™, Pfizer’s Tick-Borne Encephalitis (TBE) Vaccine, For Those at Risk of Virus Exposure

NEW YORK, NY, February 23, 2022 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Pfizer’s TicoVacTM (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older, in the following U.S. populations:

For persons who travel or move to TBE endemic areas: 

Pfizer and BioNTech Receive Positive CHMP Opinion for COVID-19 Vaccine Booster in Adolescents 12 through 17 Years of Age in the European Union

NEW YORK AND MAINZ, GERMANY, February 24, 2022Pfizer 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 administrat

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