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FDA 'Rapidly Working' On Emergency Use Authorization For Pfizer, BioNTech's Coronavirus Vaccine

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FDA 'Rapidly Working' On Emergency Use Authorization For Pfizer, BioNTech's Coronavirus Vaccine

In a historic development, an FDA committee overwhelmingly voted in favor Thursday of the agency approving BNT162b2, an mRNA vaccine being developed by Pfizer Inc. (NYSE: PFE) and BioNTech SE – ADR (NASDAQ: BNTX) against the coronavirus. 

What Happened: FDA has informed Pfizer that the agency is rapidly working toward finalization and issuance of an emergency use authorization for its co-developed investigational vaccine, FDA Commissioner Stephen Hahn said in a Friday 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 statement said.

Related Link: The Daily Biotech Pulse: Pfizer-BioNTech Receive FDA Panel Backing, Sanofi-GSK Disclose Delay In Vaccine Program, 4 Biotechs To Debut On Wall Street

Why It's Important: The U.S. has reported 288,762 deaths and 15.27 million cases in the COVID-19 pandemic, according to the CDC.

The average daily cases per 100,000 people in the past seven days were 63.3, according to the public health agency. 

The U.K., Bahrain, Saudi Arabia and Canada are among the nations that have approved the Pfizer-BioNTech vaccine candidate for emergency use.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

 

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