FDA grants priority review to Pfizer/BioNTech Covid-19 vaccine; decision on approval expected by January

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

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

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

Pfizer and BioNTech completed the rolling submission for the vaccine’s Biologics License Application for people ages 16 and older in May.