Pfizer Inc. and BioNTech SE announced they will submit a request on Nov. 20 to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020, as it was informed in the press release BioNTech.
The companies have already initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency (EMA) and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days. In some cases, governments may have regulatory pathways similar to an EUA. The companies will be ready to distribute the vaccine candidate within hours after authorization.
Pfizer is one of the leading international biopharmaceutical companies founded in New York in 1849. It is headquartered in New York and the main research center is in Groton, Connecticut.
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.
