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Dec 11, 2020 · COMIRNATY is the first COVID-19 vaccine to be granted FDA approval. Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose. More than 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories around the world since December 2020.
Pfizer is a leading developer and manufacturer of pharmaceuticals and biotech drugs. Its products include oncology and immunology drugs, treatments for rare diseases, and vaccines.
Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose ...
Aug 23, 2021 · FDA approved the first COVID-19 vaccine, which has been known as the Pfizer-BioNTech COVID-19 Vaccine, and is now marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease...
Dec 11, 2020 · From the start of the research program earlier this year, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the U.S., as well as Europe, Latin America and South Africa reaching approximately 44,000 participants.
Sep 22, 2021 · NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older.
Jun 25, 2022 · Omicron-adapted monovalent candidate given as a fourth booster dose elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg dose levels; bivalent vaccine candidate exhibited a 9.1 and 10.9-fold increase against Omicron Geometric mean ratios for Omicron neutralizing antibody response ...
Aug 24, 2021 · The FDA announced the Pfizer vaccine is the first in the U.S. that is now fully approved. Here's what that means for vaccine mandates and convincing vaccine-hesitant people to get vaccinated.
About Our Landmark Trial. The Phase 3 clinical trial was designed to determine if the Pfizer-BioNTech COVID-19 vaccine is safe and effective in preventing COVID-19 disease. This trial began July 27, 2020 and completed enrollment of 46,331 participants in January 2021.
