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. So I think that puts you on end of August, September timeframe in terms of when these are going to be approved.”
A lot of what the FDA is now doing is going through what is called the CMC – chemistry, manufacturing and controls – portion of the application, he said.
“Basically, the portion of the application that deals with the manufacturing of the vaccines so that they can put appropriate language and labeling on what the storage and handling requirements going to be for the vaccine when it’s put into general distribution, because remember we’ve been distributing the vaccine through special vaccine distribution sites,” he said, adding that once the vaccine is fully approved, it gets put into normal distribution so there has to be information on appropriate handling and shelf life.
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.