The authorization came late Friday night.
Relief is on the way for the millions living in fear of the COVID-19 coronavirus pandemic as the Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the BNT162b2 vaccine candidate from Pfizer and BioNTech.
According to a news release, the EUA allows the companies to begin distributing the vaccine across the country.
“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,” FDA Commissioner Stephen M. Hahn, MD, says in the 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.”
According to documents released by the Food and Drug Administration (FDA) for the committee meeting, Dec. 10, the vaccine has hit the efficacy and safety benchmarks to receive the EUA.
Previously, the companies announced the candidate showed 95 percent efficacy in patients not previously infected with COVID-19 and also those who have previously been infected beginning 28 days after the first dose which meets all of the study’s primary efficacy standpoints.
In July, the U.S. Department of Health and Human Services placed an initial order for 100 million doses of BNT162b2 for $1.95 billion after it is manufactured and either obtains approval or emergency use authorization from the FDA. The federal government will also be able to acquire up to an additional 500 million doses and American patients will receive the vaccine free.