Wednesday , August 4 2021

FDA Grants Priority Review of Pfizer/BioNTech Vaccine



(CNN) — Pfizer and BioNTech announced Friday that the U.S. Food and Drug Administration (FDA) has given priority review designation to companies’ requests for approval of COVID-19 vaccines. The companies said the target date for the FDA decision is January 2022.

The typical priority review process is scheduled for six months, but FDA approval may come before the target date.

Andy Slavitt, a former White House senior adviser on the COVID-19 response, told CNN earlier this month that approval could come in July, but acknowledged that it’s a complex process.

“There’s a lot of moving parts. It’s not that easy,” Slavitt told CNN’s Alisyn Camerota. “I’m hoping in the next four or five weeks and I think this will be very, very good news.”

Pfizer and BioNTech completed the biological license application for the vaccine for people over 16 in May.


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