FDA Grants Priority Review of Pfizer / BioNTech Vaccine

(CNN) — Pfizer and BioNTech announced Friday that the U.S. Food and Drug Administration (FDA) granted priority review designation to companies’ request for approval of their COVID-19 vaccine. . The target date for an FDA decision is January 2022, the companies said.

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

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

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

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

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