US Food and Drug Administration Commissioner Dr. Stephen Hahn said Wednesday that the agency does not have a set timeline to review a Covid-19 vaccine.
The goal, he said, is that everyone could get a vaccine by spring. But it “really depends on a number of factors.”
“We want to expedite it,” Hahn said at a conference sponsored by the Milken Institute, a nonpartisan think tank founded by ex-banker Michael Milken.
“We've said that we will schedule a vaccine advisory committee to review those data. We have committed for every application to have a vaccine advisory committee,” Hahn said.
“We will make that public, as I mentioned. Our scientists will make an initial determination, will ask specific questions about the product from the vaccine advisory committee. And then we will incorporate that in our decision making,” Hahn said.
“At the end of the day, only our career scientists in the Center for Biologics Evaluation and Research will be making this decision, and they will be making it solely upon the science and data that come from the clinical trials.”
To speed up the process, Hahn said the FDA has been working with manufacturers from day one and have stayed in touch throughout the manufacturing process, rather than reviewing everything at the end of the process.
“We need to make sure that there's quality and consistency and that every lot has the same ability to provide protection to all of Americans,” Hahn said. “We have a lot of confidence in the manufacturing of these developers, and we will be doing our part with respect to working with them to make sure that manufacturing can be ramped up as quickly as possible.”