COVID-19 Vaccine (Comirnaty, BNT162b2) Description
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 beta coronavirus. 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. Comirnaty contains a molecule with instructions for producing a protein from the SARS-CoV-2 virus. Comirnaty revenues were approximately $34 billion, which reflects favorable operational updates compared to prior guidance, partially offset by unfavorable incremental impacts from foreign exchange. This guidance includes doses expected to be delivered in fiscal 2022(5), primarily under contracts signed as of mid-October 2022.
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.
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. Pfizer provided an update on September 15, 2020: 'Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mild to moderate tolerability profile as observed in Phase 1.
The Comirnaty Vaccine is offered in various dose regimens, subject to country-based authorizations.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent
The U.S. Food and Drug Administration (FDA) granted Authorization for Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), as a single booster dose to include eligible people. On January 24, 2023, the U.S. FDA published a Briefing Document, Future Vaccination Regimens Addressing COVID-19. On January 26, 2023, Kena A. Swanson, Ph.D. Vice President, Viral Vaccines, presented during the FDA's Vaccines and Related Biological Products Advisory Committee meeting.
Fosun Pharma and BioNTech
In March 2020, Fosun Pharma and BioNTech announced a strategic collaboration to develop and commercialize COVID-19 vaccines based on BioNTech's mRNA technology platform for Greater China Market, including the Chinese Mainland, Hong Kong SAR, Macau SAR, and Taiwan region.
Comirnaty PREVNAR 20
On January 12, 2022, Pfizer announced positive top-line results from a Phase 3 study describing the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in 570 senior adults in the U.S. when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.
Comirnaty COVID-19 Vaccine (BioNTech - Pfizer BNT162b2) Clinical Trials
Comirnaty has been tested in over 80 clinical trials since the first quarter of 2020. Pfizer's website displays various clinical trial participant metrics.