PFIZER MAY FILE FOR EARLY COVID VACCINE USE AFTER NOV. 3
The COVID-19 vaccine Pfizer is developing with Germany's BioNTech will probably not be available for emergency use until after the US presidential election, the company said, Paul Lamonica reported for CNN Business.
In an open letter published on the company's web site, Pfizer chairman and CEO Albert Bourla said that there must be certainty that the vaccine is safe and will satisfy regulators' standards.
Bourla noted the Food and Drug Administration (FDA) Is asking for two months of data on half of the participants in a vaccine trial following the final dose of a vaccine before it would grant Emergency Use Authorization (EUA) in the US.
"Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November," Bourla wrote. That's later than what BioNTech CEO and co-founder Ugur Sahin told CNN in September. In an exclusive interview, Sahin said the vaccine could be approved by the middle of October or early November. "We believe that we have a safe product and we believe that we will be able to show efficacy," Sahn said.