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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

NEW YORK and MAINZ, GERMANY, July 19, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older. This application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to work towards introducing an Omicron-adapted bivalent vaccine candidate to address the continued evolution of SARS-CoV-2.

Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), Due To The Potential Presence of Visible Particulate.

NEW YORK, NY., July 13, 2022 Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100 mL Single Patient Use Glass Fliptop Vial; lot DX9067, to the user level due to a visible particulate observed in a single vial during annual examination of retain samples.

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

  • COMIRNATY® is the first and only COVID-19 vaccine to be granted FDA approval for adolescents 12 years and older, following emergency use authorization in May 2021
  • Approval of the two-dose primary series is based on the totality of data through six months post-dose 2 in individuals 12 through 15 years of age
  • Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial

NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc.

Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®

NEW YORK and MAINZ, Germany, July 8, 2022Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) in the European Union (EU) with data supporting the vaccination of children ages 6 months to less than 5 years with the 3-µg dose of COMIRNATY® (COVID-19 vaccine, mRNA) as a three dose series.

Pfizer Announces Commitment to Accelerate Climate Action and Achieve Net-Zero Standard by 2040

  • Pfizer aims to achieve net-zero targets ten years earlier than the expectations of the Net-Zero Standard
  • Commitment is aligned with Pfizer’s Environmental, Social and Governance (ESG) priorities
  • Pfizer also signs voluntary U.S. Department of Health & Human Services (HHS) pledge committing to reduce Greenhouse Gas (GHG) emissions and accelerate climate action 

NEW YORK, June 30, 2022 — Pfizer Inc.

Pfizer and BioNTech Provide Update on Rolling Submission to European Medicines Agency for a Potential Variant-Adapted Vaccine

NEW YORK and MAINZ, GERMANY, June 15, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the European Medicines Agency (EMA) has initiated a rolling review for a variant-adapted version of the companies’ COVID-19 vaccine. This rolling review is initially based on chemistry, manufacturing, and controls (CMC) data shared with EMA earlier this month. As clinical data become available, including data on immunogenicity against Omicron and its subvariants, it will be added to the rolling submission. 

Pfizer, MorphoSys and Incyte Enter into Clinical Trial Collaboration for Monjuvi® (tafasitamab-cxix) in Combination with TTI-622, a Fusion Protein Directed Against CD47

Pfizer Inc. (NASDAQ:PFE), MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ:MOR), and Incyte (NASDAQ:INCY) today announced a clinical trial collaboration and supply agreement to investigate the immunotherapeutic combination of Pfizer’s TTI-622, a novel SIRPα-Fc fusion protein, and Monjuvi® (tafasitamab-cxix) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). 

Hospira Issues A Voluntary Nationwide Recall For Labetalol Hydrochloride Injection, USP, Due To The Potential Of Cracked Glass At The Rim Surface Of The Vials

For Immediate Release-LAKE FOREST, IL., February 23, 2018 - Hospira, Inc., a Pfizer company, is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus® (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal. Cracked vials may result in a lack of sterility assurance for the product.

Hospira Issues A Voluntary Nationwide Recall For Hydromorphone HCL Injection, USP CII Due To The Potential For Empty Or Cracked Glass Vials

For Immediate Release-LAKE FOREST, IL., March 05, 2018 - Hospira, Inc., a Pfizer company, is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to the hospital/institution level. Hospira, Inc. initiated this recall on February 07, 2018 due to the potential that units from these lots may be empty or cracked at the bottom of the glass vial.

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