Comirnaty COVID-19 Vaccine
BioNTech S.E. and Pfizer, Inc. co-developed the U.S. Food and Drug Administration (FDA) Approved Pfizer-BioNTech Comirnaty® COVID-19 Vaccine (BNT162b2) vaccine to prevent severe COVID-19 caused by the SARS-CoV-2 betacoronavirus. Comirnaty is based on BioNTech proprietary messenger RNA (mRNA) technology. Comirnaty 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 coronavirus. On July 1, 2020, the manuscript describing the preliminary clinical data for the Comirnaty vaccine became available for scientific peer review. Pfizer and BioNTech stated on August 5, 2020, they began a Phase 2b/3 safety and efficacy trial. Pfizer's website displays various clinical trial participant metrics.
The U.S. FDA initially Approved the Pfizer-BioNTech COVID-19 Vaccine on August 23, 2021. The Comirnaty COVID-19 vaccine received multiple authorizations in more than 40 countries and regions. On May 1, 2024, Pfizer announced that in the first quarter of 2024, Comirnaty revenues of $354 million declined by $2.7 billion, or 88%, operationally compared with the prior-year quarter.
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.
U.S. FDA VRBPAC Presentation
Kayvon Modjarrad, M.D., Ph.D. Executive Director, Viral Vaccines & Immunology Vaccine Research and Development, Pfizer Inc., presented to the FDA's VRBPAC on June 5, 2024.
Comirnaty Dosage
The Comirnaty Vaccine and Pfizer-BioNTech COVID-19 Vaccine are offered in various dose regimens, subject to country-based authorizations.
Comirnaty Availability
On July 24, 2024, the U.K. Medicines and Healthcare Products regulatory Agency approved an adapted Pfizer/BioNTech COVID-19 vaccine (Comirnaty) that targets the JN.1 COVID-19 subvariant.
