Pfizer asks FDA to allow emergency use of vaccine

Pfizer and its German Partner BioNTech has asked U.S. regulators to allow emergency use of their COVID-19 vaccine, starting a process that could bring first shots as early as next month.

Video Transcript


BARRY COLVIN: Well, I'm curious whether I received the vaccine or placebo, the fact is I think either one you're in, whether you're in the control group or whether you received the vaccine, both are, I think, equally contributing to forwarding the progress.

ALBERT BOURLA: But I can say that our request for emergency-use authorization for our COVID-19 vaccine is now in the FDA's hands.

JESSE GOODMAN: Emergency-use authorization is an authority given to FDA by law that is intended to help respond to a public-health emergency, basically. The challenge is going to be that data may only be from, you know, two to four months of experience. So we're not going to know the durability of protection, although most adverse events occur in a relatively short period after vaccination. We won't have that long follow up on safety.

In the case of a COVID vaccine, it might be that the intent is to have early limited doses available under emergency use to go to people at highest risk of infection or of its complications. So it could be the people exposed as first responders or in the health-care environment or to people with risk factors for severe disease.

BARRY COLVIN: I'm not a health-care worker, so I'm not able to help in that way-- or an essential worker for that matter. But there is something I can do. This is what I can do.