Pfizer COVID-19 Vaccine Data Wins Backing of U.S. FDA

The vaccine’s efficacy and safety data met its expectations for emergency use authorization, FDA staff said in documents released ahead of a meeting of outside experts to the FDA who will discuss whether to recommend the Pfizer shot for people aged 16 and older. Jefferies analyst Michael Yee said in a research note the documents were “very simple and straightforward, which we think will lead to approval imminently.”

The agency typically follows the recommendations of its advisory panels but is not required to do so. It is not clear how many days or weeks the FDA will take to make a decision, but states are prepping for vaccine deliveries in mid-December.

Deaths from COVID-19 in the U.S. have soared to more than 2,200 a day on average, matching the frightening peak reached last April, and cases per day have eclipsed 200,000 on average for the first time on record, with the crisis all but certain to get worse because of the fallout from Thanksgiving, Christmas and New Year’s.