Comirnaty COVID-19 Vaccine
BioNTech S.E. and Pfizer, Inc. co-developed the U.S. Food and Drug Administration (FDA) Approved Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) vaccine to prevent severe COVID-19 caused by the SARS-CoV-2 betacoronavirus. The vaccine is based on BioNTech proprietary messenger RNA (mRNA). The U.S. FDA Approved the Pfizer-BioNTech COVID-19 Vaccine on August 23, 2021. Known globally as Comirnaty, the vaccine is a nucleoside-modified RNA formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen. In addition, Comirnaty contains a molecule with instructions for producing a protein from the SARS-CoV-2 virus.
In December 2022, BioNTech and Pfizer announced that approximately 2 billion doses of COMIRNATY® were invoiced globally in 2022 between the two companies. On June 15, 2023, the U.S. FDA published a Briefing Document, as did Pfizer/BioNTech: 2023-2024 COVID-19 Vaccine Formula. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization for active immunization to prevent COVID-19 in individuals six months and older.
On September 11, 2023, the companies announced the FDA Approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) for individuals 12 years and older and granted emergency use authorization for individuals six months through 11 years of age for the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. In Europe, the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) also received marketing authorization on August 31, 2023, from the European Commission for individuals six months of age and older.
Germany-based Biopharmaceutical New Technologies (BioNTech.E.) is the Marketing Authorization Holder in the U.S., Europe, and the U.K. and the holder of emergency use authorizations or equivalents in the U.S. (jointly with Pfizer), Canada, and other countries. Biopharmaceutical New Technologies is an immunotherapy company pioneering novel therapies for cancer and other serious diseases.
New York-based Pfizer Inc.'s corporation information is updated at this link.
Comirnaty Omicron XBB.1.5
The Comirnaty Omicron XBB.1.5 vaccine prevents COVID-19 in adults and children from 6 months. In line with previous recommendations by the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), adults and children from 5 years of age who require vaccination should have a single dose, irrespective of their COVID-19 vaccination history. Children from 6 months to 4 years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19.
BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines (COMIRNATY Original/Omicron BA.1; COMIRNATY Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
The Comirnaty Vaccine and Pfizer-BioNTech COVID-19 Vaccine are offered in various dose regimens, subject to country-based authorizations.
On July 1, 2020, the manuscript describing the preliminary clinical data for the Comirnaty vaccine became available online for scientific peer review for potential publication. Pfizer and BioNTech stated on August 5, 2020, they began a Phase 2b/3 safety and efficacy trial. Comirnaty has been tested in over 80 clinical trials since the first quarter of 2020. Pfizer's website displays various clinical trial participant metrics.