Vaccine Info

Comirnaty COVID-19 Vaccine

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Last reviewed
June 6, 2024
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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 virus. 

The U.S. FDA Approved the Pfizer-BioNTech COVID-19 Vaccine on August 23, 2021. 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.

BioNTech and Pfizer's Omicron XBB.1.5-adapted monovalent COVID-19 vaccine received multiple authorizations in more than 40 countries and regions. In 2023, BioNTech and Pfizer delivered more than 400 million COVID-19 vaccine doses worldwide. 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 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). 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.

Comirnaty Dosage

The Comirnaty Vaccine and Pfizer-BioNTech COVID-19 Vaccine are offered in various dose regimens, subject to country-based authorizations.

Comirnaty History

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.

Clinical Trials