FDA Authorizes COVID-19 Vaccine For Emergency Use In U.S.

Enlarge this image

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

hide caption

toggle caption

Andrew Harnik/Pool/Getty Images

Shots — Health News
U.S. Government May Find It Hard To Get More Doses Of Pfizer’s COVID-19 Vaccine

Shots — Health News
FDA Panel Recommends COVID-19 Vaccine For Emergency Use

That’s a key consideration with the authorization process, which has unfolded against the backdrop of a pandemic currently killing record numbers of people per day in the United States. Nearly 300,000 people in the U.S. have died of COVID-19 since the start of the year, according to data compiled by Johns Hopkins University — a staggering death toll that now exceeds the number of Americans killed in battle during all of World War II.

That means an urgent quandary for health regulators around the world, many of whom, including in the U.S., have departed from the usual approval process to ensure a speedier response to the pandemic. The FDA has relaxed its usual review mechanism to allow drugs, tests and vaccines to get out more quickly than the usual, more stringent requirements for full-blown approval would otherwise allow. This speedier path is called emergency use authorization.

The Pfizer vaccine, which is administered in a pair of doses three weeks apart, has been demonstrated to be 95% effective in clinical trials.

But it’s not the only vaccine to show promising results.

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.

Scott Hensley contributed to this report.