Why Pfizer’s Covid vaccine has been authorized in the UK but not the U.S. yet
Berkeley Lovelace Jr.
The U.K. this week became the first country to authorize Pfizer’s coronavirus vaccine for emergency use, likely adding pressure on the U.S. Food and Drug Administration to quickly do the same.
To be sure, the U.S. and the U.K. review vaccines differently. Pfizer had been submitting data on its vaccine with BioNtech on a “rolling basis” to the U.K., meaning regulators there were able to review the data in real time and do so until there was enough evidence to support a formal authorization. A rolling review is a tool that regulators use to speed up the assessment of promising drugs or vaccines.
In the U.S., the FDA will go through every aspect of the data submitted in the application, including reviewing all safety information “to make sure there are no cracks” and everything is “solid,” said Dr. Paul Offit, a voting member of the Vaccines and Related Biological Products Advisory Committee, which is scheduled to review Pfizer’s vaccine on Dec. 10.