US: FDA to 'rapidly' proceed with Pfizer approval

ANKARA

US Food and Drug Administration (FDA) said Friday that it will quickly work toward finalization and issuance of an emergency use authorization for the Pfizer/BioNTech coronavirus vaccine.

The announcement came a day after an advisory panel recommended to the FDA that it granted the emergency use by a 17-4 vote.

"Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, 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," FDA Commissioner Stephen M. Hahn and Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

"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 US continues to be the worst-hit country by the virus with over 15.6 million COVID-19 cases have been confirmed in the US as well as more than 292,000 deaths, according to data from Johns Hopkins University.

Numbers of COVID-19 daily deaths and cases have been hitting grim records in recent weeks. Over 221,000 cases were confirmed Wednesday, as well as 3,124 deaths, an all-time high.

ANKARA

US Food and Drug Administration (FDA) said Friday that it will quickly work toward finalization and issuance of an emergency use authorization for the Pfizer/BioNTech coronavirus vaccine.

The announcement came a day after an advisory panel recommended to the FDA that it granted the emergency use by a 17-4 vote.

"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."

Numbers of COVID-19 daily deaths and cases have been hitting grim records in recent weeks. Over 221,000 cases were confirmed Wednesday, as well as 3,124 deaths, an all-time high.