The U.S. Food and Drug Administration on Friday gave emergency approval to a COVID-19 vaccine developed by Pfizer and BioNTech.
FDA Commissioner Dr. Stephen Hahn and the Center for Biologics Evaluation and Research Director Dr. Peter Marks confirmed the authorization in a statement issued Friday night.
“The U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” the statement said. “The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”
The U.S. is now the third country in the world to authorize the Pfizer/BioNTech vaccine for public use. The others were the U.K. and Canada.
The FDA authorized the vaccine, called BNT162b2, after a trial involving more than 43,000 people found it was effective at preventing the coronavirus 95% of the time. The vaccine uses innovative messenger RNA technology to introduce the body to the spike protein on the surface of the coronavirus. Results of the trial were published in the New England Journal of Medicine on Thursday.
Locally, shipments of the vaccine are expected to begin next week. A second vaccine, developed by Moderna, could be approved in the coming weeks.
— Mitchell White