Wednesday, the U.K. became the first country to approve Pfizer’s (NYSE: PFE) coronavirus vaccine for emergency use, and will begin administering shots in just a few days. The move is recorded as a historic step towards possibly ending the ongoing pandemic, which has killed over 1.4 million people worldwide.
“This is a day to remember, frankly, in a year to forget,” British Health Secretary Matt Hancock said.
As a result, the U.S. Food and Drug Administration are under pressure to quickly follow suit but are not scheduled to consider the vaccine until December 10.
Procedures for vaccine reviews are different in the U.S. and the U.K. Pfizer was able to submit data on a “rolling basis,” to the U.K., which means regulators were able to analyze data in real-time until there was sufficient information to authorize said vaccine.
However, within the U.S., the FDA carefully runs through every detail of the data turned in from the application. All safety data is assessed “to make sure there are no cracks” and all aspects are “solid” according to 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.
“I don’t know what data the U.K. was working with. I know when data is submitted to the FDA, it’s voluminous,” said Offit, also director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “When you talk about a 44,000-person trial, that’s a lot of clinical data.”