Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, and a board member at Pfizer, said that when it comes to full approval of Covid-19 vaccines, much of what the FDA is now doing is going through the portion of the application that deals with manufacturing. “I long felt that the FDA would approve the vaccine probably within a three to four month time frame from when the application was submitted,” Gottlieb said on NPR’s Morning Edition Wednesday. “Those applications were submitted about two and a half, three months ago, including the application from Pfizer, the company I’m on the board of, I think they submitted the application in late May. A lot of the clinical portion of the review has probably already been done because the information has been going to FDA on a rolling basis and it has been evaluating the clinical performance all the way through. “I think that you’re going to see these get fully licensed, but the reality is the bulk of the work, and what people think of in terms of the core of the application, the clinical data, a lot of that’s already been reviewed, the agency has gotten comfort around that, in my estimation,” he said.

Source: CNN July 28, 2021 17:48 UTC