Your questions, answered "When is the FDA expected to provide FULL (non-emergency) APPROVAL of the Pfizer and other coronavirus vaccines? What time frame? How would one find that information?" — Jimmy in Arizona This is a good question — and one we get quite a bit. The Food and Drug Administration is facing mounting pressure to grant regulatory approval to the coronavirus vaccines that have been authorized for emergency use. As you may know, emergency use authorization is a way to use unapproved medical products, such as vaccines, during public health emergencies. However, it is a rigorous process. For full FDA approval, the clinical trial participants must be tracked for at least six months to monitor for serious adverse reactions. As The Washington Post's Laurie McGinley reported, Pfizer and BioNTech submitted their request for full approval in May and, the next month, Moderna started the submission process. Johnson & Johnson has said it will submit its application later this year. In a recent interview with McGinley, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, which regulates vaccines, said that the agency is essentially "in a sprint" to complete the approval process for the Pfizer-BioNTech vaccine. Asked when the FDA is expected to grant full approval to Pfizer, Marks told McGinley: 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. 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 explained that although the review process can differ for each vaccine, "the FDA aims to complete priority vaccine reviews within eight months of receiving an application for approval and standard reviews within 12 months of receipt." Why does it take that much time? The FDA has a lot to consider, he said: The whole process has to work, there have to be appropriate controls and the testing that has to be done. It's not just the vaccine drug substance, but also how that drug substance is made into drug product and put into the vials. The whole process is inspected, and then we have to make sure that the end product is truly ready to be released. There are a lot of different steps that the FDA has to review that go into all of this. Marks said that it remains to be seen whether the FDA's official seal of approval will affect vaccination rates, but he is hopeful. "Whether they will show you the money and get vaccinated afterwards or not, I believe that at least some of them will," he said. | 
Email 
