This week, U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, spends some time answering questions from host Serena Marshall. Listen and subscribe on Apple, Stitcher, or Google so you don’t miss the next one. And if you like what you hear, a five-star rating goes a long way in helping us spread the word! Below are a few edited excerpts from this week’s interview with Dr. Hahn. Right now there are nearly a dozen vaccines in phase 3 clinical trials or wrapping them up. That means tens of thousands of participants in each trial are being evaluated as they receive an experimental shot or the placebo. Both U.S.-based Moderna as well as Pfizer and BioNTech have mRNA vaccines and are the furthest along in the U.S. regulatory process. Both have already submitted data to the FDA so the FDA scientists can evaluate their vaccine and hopefully get it approved for emergency use. Now, what does emergency use authorization mean? It would allow the FDA to make one or more vaccines available for a limited use right now even without all the evidence they would normally require to show that in the long run it works. Pfizer has already begun to position itself for distribution, partnering with United Airlines and other agencies to get their vaccine out fast. Meanwhile, the CDC [Centers for Disease Control and Prevention] has met to recommend who should be the first to get a coronavirus vaccine. But of course, all of this will depend on the FDA’s upcoming decision, and that’s why we’re starting out our premiere episode with FDA Commissioner Dr. Stephen Hahn. Dr. Hahn: It is a busy time, Serena, and since the spring we have been preparing for the time when we might receive an application for a vaccine and, in this case, an application for an emergency use authorization. We have a division within the FDA that solely works with vaccine manufacturers and looks at their applications, and that is within our Center for Biologic Evaluation Research. That group has decades of experience and incredible scientific expertise looking at applications for vaccines. These are very complicated applications involving tens of thousands of participants in clinical trials. We have significant, as I said, expertise that allows us to scientifically evaluate an application. Our role here is to look at an application and to judge whether a vaccine is safe and effective, and also look at manufacturing quality to ensure that every vaccine that comes off the manufacturing line has the same high quality. Serena Marshall: In that preparation process, are you going to these manufacturers and doing spot checks? Are you [doing] background research to prepare for whatever kind of application is presented to you? Because we haven’t seen the data yet and I’m assuming, until those emergency use authorizations are presented, the FDA hasn’t seen the data? Dr. Hahn: That’s correct. As you know, these large, phase 3, late-stage clinical trials are being performed in the late summer and fall. They are controlled by the manufacturers, the developers of vaccines. When they determine that the data is ready, they have obviously announced that, but then they submit an application to us, and as you know from the press, an application has been submitted to us from Pfizer for their mRNA vaccine. In preparation, knowing that these trials are ongoing, we have been working very closely with the manufacturers with respect to their manufacturing sites, trying to understand exactly where they are going to manufacture and then doing our inspections, follow up with them, understanding their manufacturing techniques, those sort of things, so that we had a significant amount of that work done before the application was received. Now, that being said, there is still a lot of data for us to review and our commitment to the American people is that we will be very thorough while working expeditiously to look at this. But we will not cut any corners in our assessment of the safety, effectiveness, and quality of the vaccines. Serena Marshall: What is the FDA looking for in approving this vaccine for emergency use? Are there certain check boxes that you need to have committed to in order to say, “Yes, this is going to go forward,” or, “No, this is not”? Dr. Hahn: I refer everyone back to our June 30 guidance regarding what we’re looking for in vaccines. We made it clear that many of the criteria that we’re looking at were our standard criteria that we’ve used for, as I said, decades to evaluate vaccines. Because remember, even though we always look at the risk and benefit of a product, we realize that in this setting a vaccine’s going to go to people who aren’t sick with COVID-19, which is different than someone who’s sick with COVID-19. Safety takes on even more importance than it otherwise would. We also had guidance in early October regarding what we would expect to see on an application for an emergency use authorization, and we made it clear that we wanted to see clear and compelling data from at least one randomized phase 3 trial. I have to tell you I have complete and absolute confidence in the incredible expertise that these scientists have and we will make a determination regarding safety and efficacy based upon our very stringent criteria. Serena Marshall: Now, vaccines, as everyone knows, often take decades to develop, research, and manufacture, and here we are, less than a year later, with not one but three, really, possible vaccine candidates that are showing efficacy high above what you, the NIH [National Institutes of Health] and other scientists wanted to see. What would you say to people who are looking at those numbers and saying, “How can that be that we don’t just have one candidate now, we have three?” Dr. Hahn: I think we’re all hoping that the data supports a highly effective and safe vaccine; and if that is the case, it is a remarkable medical event and I think we’ll all welcome that. The fact that these vaccines may have high levels of effectiveness may tell us something about the virus itself and the immune response, and that could be very helpful to researchers in the future as we look to other vaccines for other diseases, but also for other viruses in the future. This may be very helpful for future research into vaccines. Serena Marshall: We still need to exercise all those public health measures and prevent the spread. Are we overpromising Americans who are excited about this? Dr. Hahn: If, in fact, the data supports what we’ve heard, it is remarkable, as you and I just discussed — medically remarkable, scientifically remarkable — but it will take time after that to vaccinate enough people to get what we call herd immunity, which will be immunity in about 70 percent, is what the experts are saying, of Americans, and begin to put this virus behind us. In the meantime, our best defense, while we hopefully look forward to the future — and a future that includes a vaccine that’s safe and effective — while we do that, our mitigation procedures and the efforts we need to take, including following the CDC’s guidance for gatherings, all of those things are important. Mask-wearing, washing hands frequently or using hand sanitizer, social distancing, and protecting the most vulnerable, and particularly, as we think about our holidays coming up in the near future, making sure we limit the number of people indoors, because that is where we’re beginning to see a significant amount of this community spread. SM: Dr. Hahn, I think everyone would want to know, when will you get it? Dr. Hahn: The FDA houses the most brilliant scientists in the world. When they say it’s ready, it’s ready, and I’d be the first to take it and show that. Read the full transcript on MedPage Today.
