The FDA issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of SARS-CoV-2 (which causes the coronavirus) for people aged 16 years or older.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, MD, in a statement.
An FDA panel voted last night determining that the benefits of the vaccine outweigh the risks. Now that the EUA is granted, the Pfizer-BioNTech COVID-19 Vaccine can begin to be distributed throughout the U.S.
The Pfizer-BioNTech COVID-19 Vaccine is administered in two doses given 21 days apart. While a large clinical trial of more than 37,000 participants showed that it is 95% effective, it will continue to be monitored for safety and efficacy.
“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”
Oncology nurses and their colleagues may be some of the first individuals to receive the vaccine, as the CDC previously reported that health care providers will be among the first group to get it.
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide,” Hahn said.