• 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).

• Read more about 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. 

• Read more about Pfizer and BioNTech Provide Update on Ongoing Studies of COVID-19 Vaccine

NEW YORK and MAINZ, GERMANY, DECEMBER 17, 2021 — Pfizer Inc. (NYSE: PFE) and

• Read more about 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.

• Read more about 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 TicoVac^TM (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: 

• Read more about 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, 2022 — 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 administrat

• Read more about 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, 2022 — 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 administrat

• Read more about FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) InterchangeabilityFDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

NEW YORK, February 25, 2022 – Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022.

• Read more about Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults

•    Submission based on real-world safety and efficacy data from Israel 
•    Data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of Pfizer-BioNTech COVID-19 Vaccine compared to individuals who received only an initial booster