December 12, 2020

FDA Authorizes COVID-19 Vaccine For Emergency Use In U.S. But 'Normal' May Not Return Until Next Fall


An example of a vial that will carry the COVID-19 vaccine produced by Pfizer and BioNTech sits on display during a Senate subcommittee hearing Thursday.

Andrew Harnik/Pool/Getty Images

Federal officials have authorized emergency use of the COVID-19 vaccine produced by Pfizer and BioNTech in a landmark decision that promises to alter the fight against the coronavirus radically in the United States.

The Food and Drug Administration released its letter to Pfizer granting the authorization Friday evening.

But Dr. Paul Offit, a member of that panel, cautioned it could be next fall before life gets back to normal after the pandemic.

That fall prediction would depend on two-thirds of the American population getting the vaccine, he told NPR's Morning Edition.

"The problem is logistics," Offit said. "It's a matter of making the vaccine and distributing it. It's making sure people get it, that they aren't sort of swayed by ... what is a lot of misinformation that surrounds not only this vaccine but all vaccines. That's going to be the hang-up.

In the first push after authorization, the government expects 2.9 million doses of vaccine to go out. Shipments are expected to begin within 24 hours. Government officials have said they'll be able to supply enough doses of vaccine for 20 million people by the end of the year.

"We have clear evidence that the vaccine is highly effective at least three months after getting the first dose, and given the other data they presented, I think it's likely to be effective for much longer," Dr. Paul Offit told NPR's Morning Edition on Friday in advance of the FDA announcement.

Despite some disagreement by experts on the advisory panel over the adequacy of evidence to support use of the vaccine in people as young as 16, the vaccine was authorized for use in people 16 and older.

The vaccine shouldn't be given to people with a history of severe allergic reactions to any of the ingredients in the vaccine, the instructions say.

The prescribing instructions don't preclude use of the vaccine in pregnant women or women who are breastfeeding, but they say that there isn't enough information to assess the effects of the vaccine or its risks under those circumstances.

Another vaccine, this one produced by Moderna, has been more than 94% effective in trials and is currently awaiting its own authorization by the FDA. At a public meeting on Dec. 17, a panel of expert advisers to the agency will meet to consider the evidence for the vaccine and make a recommendation about it.