FDA Grants Pfizer / BioNTech Covid-19 Vaccine Priority Review; approval decision expected by January 2022

The typical priority review process allows six months, but FDA approval could come before the deadline.

Andy Slavitt, a former White House senior adviser on the Covid-19 response, told CNN earlier this month that the approval could take place in July, but admitted it was a complex process.

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

Pfizer and BioNTech completed the continuous submission of the vaccine biologics license application for people 16 years of age and older in May.