Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the US Food and Drug Administration, said in an interview with the Washington Post Friday that the center will work towards getting Pfizer’s Covid-19 vaccine full FDA approval as quickly as possible.
“I can’t speak to a date when we intend to have this done. But what I can say is we are going to move with all due diligence to get the review done with our usual high quality, as rapidly as we can,” Marks told the Washington Post about when he thinks the FDA will give full approval to the Pfizer Covid-19 vaccine. We know how important it is for people to be able to get vaccinated. We know that there are students going back to college who would like to see a licensed vaccine before they get vaccinated. And we understand that, and we will work toward getting this across the finish line as rapidly as possible.”
Marks also explained the difference between what is required for emergency use authorization, which all the vaccines currently have, and full approval, saying that “in terms of pages to review the change is an order of magnitude. It’s going from tens of thousands of pages, to hundreds of thousands of pages.”
Manufacturing for a full approval also has to be “much more well-described and detailed” than for an EUA, he said, as well as additional inspections of facilities that have to be done.
Marks said that what is normally done for biologic license applications is to have six months of follow-up data on those who received the vaccine in clinical trials. He said that the data from the millions of people who have gotten the vaccine but were not part of trials can’t be used because “we don’t follow all those millions of people in the same manner that we are able to follow people who are enrolled in clinical trials.”
When it comes to manufacturing issues being looked at by the FDA, Marks said “The whole process has to work, there have to be appropriate controls and the testing that has to be done,” adding that it isn’t just the vaccine drug substance, but also how it is made into a product and put into vials. The whole process is inspected and then the FDA has to make sure that the end product is ready to be released.
He said that each vaccine review is unique, but the FDA aims to complete priority reviews within eight months of receiving and application and standard reviews within 12 months.