The data Pfizer and BioNTech have released so far on their Covid-19 vaccine candidate “are really exciting and give us great hope,” US Food and Drug Administration Commissioner Dr. Stephen Hahn said Thursday.
“It’s the equivalent of a medical home run, maybe a Grand Slam, who knows, but really impressive from what we’ve heard so far,” Hahn told NBC News.
The companies said this week the data from the clinical trials show the potential coronavirus vaccine is 95% effective in preventing disease and that they plan to file for an emergency use authorization from the FDA on Friday.
Hahn said the agency needs to see the raw data on the vaccine.
“So what will be submitted to us is raw data around the clinical trial that would support a claim for safety and effectiveness of the vaccine, which of course is our primary responsibility here, with an emergency use authorization or an outright approval,” he said.
That’s not the only thing the agency reviews.
“We’ll also be looking at manufacturing data because the other thing we need to ensure is that every vaccine that comes off the manufacturing line has the same high quality and represents the vaccine that was part of the study,” Hahn noted.
After the FDA receives the application, Hahn said the agency will set a date for a meeting of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC. A source told CNN this week the date had already been set, for December 8, 9 and 10. But Hahn said a date has not yet been set.
Once the application is submitted to the FDA, agency scientists review it and come to their own conclusions, Hahn said.
