The US Food and Drug Administration’s emergency use authorization for Pfizer’s Covid-19 vaccine is a “significant milestone” in preventing a pandemic that has killed practically 300,000 Americans, FDA Commissioner Dr. Stephen Hahn mentioned Friday.
“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,” Hahn mentioned in a press release.
“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.”
The emergency use authorization allows the Pfizer-BioNTech Covid-19 vaccine to be distributed in the US, the FDA said in a news release.
It’s not an FDA approval, but the EUA “holds the promise to alter the course of this pandemic in the United States,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, mentioned in a press release.
“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,” Marks mentioned.