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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

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

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.

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

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