“Track the Vax” is a new weekly podcast where we speak with leading experts, pharmaceutical companies, and other physicians and patients on the latest news and science behind the race for a COVID-19 vaccine. This week, FDA Commissioner Stephen Hahn, MD, spends some time answering questions from host Serena Marshall.
Following is a transcript:
Serena Marshall: Welcome to the premiere episode of Track the Vax, a podcast in collaboration with MedPage Today and Everyday Health. I am your host, Serena Marshall, a medical journalist. On this podcast, we’re going to take you with us as we explore every angle of a COVID-19 vaccine, from development to distribution to disease prevention, where science drives the story.
Today we’re joined by FDA Commissioner Dr. Stephen Hahn. His agency is going to be responsible for approving any and all vaccines that would be used here in the U.S. Before we get to that, though, let’s take a look at the latest headlines in the global vaccine charge.
Right now there are nearly a dozen vaccines in phase III 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 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, busy time for you guys, but your agency [is] responsible for deciding when this product, when these shots are safe to give to the American public. We’ve heard a lot about these emergency use authorizations. Tell us, what have you guys been doing to prepare?
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 Biologics Evaluation and 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.
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 hadn’t seen the data?
Hahn: That’s correct. As you know, these large, phase III, 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 are 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.
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”?
Hahn: Yes. It’s a really good question. 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 a 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 III trial. We’ve seen those phase III trials be completed and we’ve heard early reports of their data, but you make a really good point, which is that we have to see those data, because what the FDA does is we crunch the numbers. We look at the data. We come to our own conclusions. We just don’t rely upon a press briefing or a scientific document per se. Our scientists and statisticians look at the data.
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.
Marshall: Some of that criteria, though, did change, that you needed a larger sample size in some of these cases to ensure you included minorities. Would there be any situation in which you might look at this and say, “You know what? We actually need a bigger sample set”? Or, “We don’t think that these populations are represented appropriately and we want to see you guys go back to the drawing board,” now that the EUA [emergency use authorization] has been submitted?
Hahn: I can’t prejudge what our decision will be, but that’s our job, is to look at the data, to ask the questions that you’re asking, so, is it representative of America as a whole? Does it include underrepresented minorities, the elderly, those with other illnesses such as hypertension, diabetes, heart disease? We need to make sure that’s the case so that our decision is generalizable.
We need to look at the effectiveness and the safety in each of those groups, and we need to ensure that the data — when we crunch them, when we look at them, when we make that evaluation — support the conclusions that have been presented to us. As I said, we’ll make our own conclusions based upon this and we will be independent in that assessment.
Marshall: Now, vaccines, as everyone knows, often take decades to develop, research, manufacture, and here we are, less than a year later, with not one, but three, really, possible vaccine candidates that are showing efficacy far high and above what you, the NIH, and other scientists wanted to see. You wanted to see 50% or at 70%, or 90%, 95% efficacy. That doesn’t just seem remarkable, Dr. Hahn. It seems a little unbelievable. 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?”
Hahn: This is, I believe — if the data support the conclusions that have been released by the manufacturers in the press — it is remarkable. When we set that threshold in our June guidance for 50%, what we said was that’s the minimum effectiveness we wanted to see in a vaccine. We and I have repeatedly said that, of course, we want to see a more effective vaccine, but the data had to support it.
We’ll be seeing whether the data support it and I can’t prejudge that. I think we’re all hoping that the data support 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. But part of our job is to ensure that when we look at the data, as I said, that it supports that conclusion.
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.
Marshall: Two of these vaccines are mRNA. That hasn’t been approved ever for use in a vaccine. When you have people … when we’re looking at that and we’re saying, “This is a brand new technology,” how are you going to judge that effectiveness, that data point, against a new technology?
Hahn: It’s a really good question, Serena, as both the Moderna vaccine and the Pfizer vaccine are using this platform of mRNA. There have been significant years of research that’s gone into mRNA vaccines. It’s not completely new.
That being said, what we will have to do as part of our post-marketing if, in fact, a vaccine is authorized or approved, part of our post-marketing work, once it goes into people, we will have to have an ongoing assessment of some of the issues just raised. What is the long-lasting immune effect, the effectiveness? Is there a booster that needs to take place further down the road? And also ask questions about the safety, both medium-term and long-term.
We are planning a very vigorous surveillance system in close cooperation with the Centers for Disease Control and Prevention, who are primarily responsible for this, and that will, of course, inform any decision we make in the future. But let me just be clear about this in general. When, in the past, FDA has approved vaccines, we have also required this post-marketing surveillance.
Because with any specific infectious disease or platform, we can’t be completely sure when the vaccine application comes to us that there is long-lasting immune effect, and we also look for safety long-term. The situations, while it is a new platform, do have some similarities to previous approvals of vaccines.
Marshall: Dr. Hahn, I want to come back to that post-marketing surveillance because it’s such an important point. But before we go to what comes after that EUA, let’s talk about the committees that are looking at this for approval. You have the FDA that’s going to be ultimately responsible for determining if it’s safe and effective and granting it that EUA, but there’s also those other committees that are going to be looking at this that really are kind of a separate entity from the government in some ways. They have to prove that they’re not associated with the pharmaceutical industry, have no ties to industry, and are all experts in their field. How will their recommendation play into your decision to approve this or not?
Hahn: Serena, that’s a really important question. I think you’re referring to the Vaccine and Related Biologics Advisory Committee. We use advisory committees for our medical products at FDA to specifically ask questions of experts around the country to assist in making the decisions. Our advisory committees are just that, advisory. We are not bound to their decisions, but we take very seriously their recommendations to us.
Let me just explain what happens. We’ll provide a company summary of the data, as well as FDA’s assessment of the data, and we will create public documents that will be used by the members of this committee.
You may remember on our October 22 committee meeting where we talked in general about vaccine development for COVID-19, that the public documents were made available in advance. We’ll do that again. The timetable is a little bit more compressed, but they’ll be available before the meeting, and then the meeting will be an open meeting.
At that meeting, we will present several questions to the committee. Those experts will look at the questions. They’ll ask questions themselves about the data, but then give us their recommendations and answers to those questions and vote on those, and that will be a public process.
Then we’ll take that into account and thereafter make a decision based upon our assessment, but also the recommendations from the committee. This is a standard process, this is something that we promised we would do, and we’re going to follow through on that promise.
Marshall: And the data, everyone is wanting to see that data. When can we expect to see it? You said we’ll see it before that public meeting, but how far in advance and have you seen it?
Hahn: We, at the FDA, have seen it. We’re looking at the data right now and it’s too early to draw any conclusions, but I can assure you that our team is working night and day on this. They’re working around the clock, and when the data analysis is ready, which we expect to be before, obviously, this committee meeting, we will make that available to the American people, as well as the committee.
Marshall: Once the EUA is approved, you mentioned that post-marketing surveillance is so important. How do you guys plan to go about doing that? We’ve heard some of these companies say that once this is unblinded we’ll probably offer this vaccine to the placebo group, which could really be detrimental to those long-term follow-ups and surveillance.
Hahn: As you can imagine, this is an important topic that had been previously discussed at our October 22 vaccine advisory committee meeting, and it’s a really important, both medical and scientific, but also ethical issue. We’ll be spending some time talking about that and probably discussing with the vaccine advisory committee as we move forward.
For the moment, these trials should continue and we should continue to collect data in the placebo arm, so that we have as robust information as possible for us to know long-term and medium-term how these vaccines affect individuals in a variety of different groups.
But more to come on that. It’s a really important question and you’ll see that this is something that we’ll engage with medical experts around the country on, as well as our government partners, including the CDC.
Marshall: Is there a way that you guys at the FDA could approve this and have regulations on whether or not they can unblind it and provide those vaccines to that placebo group? If there is no control, how are we supposed to monitor the long-term effects of these vaccines? We only have 2 months of data, as we’ve discussed. Oftentimes it’s 6 months of data before a vaccine is approved. How will you ensure that there is that control to look at the long-term data on these vaccines?
Hahn: As I said, we’re going to work closely with the manufacturers and we’re going to make decisions regarding that. We’re going to take into consideration the medical, scientific, and ethical issues. Remember also, Serena, not everybody’s going to be vaccinated and not all populations will be vaccinated because of supply issues.
If there is, in fact, an authorization, there will be a prioritization made, recommendations made by U.S. government, and then implemented by states as they see fit. Part of that equation, if you will, will be the consideration of what to do in the placebo arms. Again, it’s really too early to judge on that, Serena, but we take this issue very seriously. There are important medical, scientific, and ethical concerns.
Marshall: Dr. Hahn, we talk often about an emergency use authorization or nothing, but is there a third option or a fourth, even, that the FDA could grant some access, maybe expanded access, and not a full EUA?
Hahn: You probably heard in our October 22 meeting the discussion of expanded access and at this point we have in front of us an application for an emergency use authorization. That is what we’d expect to make a decision, a thumbs up or thumbs down on, soon thereafter the December 10 vaccine advisory committee.
We have a lot of different tools at FDA, as you point out, and we will consider all of them. But right now what we’re really looking at is the emergency use authorization and seeing whether the data support the safety and efficacy and the statutory requirements for an EUA.
Marshall: Dr. Hahn, you mentioned those safety-monitoring programs. Are we just going to be seeing the standard safety vaccine monitoring systems in place here or are there going to be special programs and protocols in order to monitor these emergency use vaccines?
Hahn: Serena, because of the urgency of the situation, the incredible way that these clinical trials were performed, our subsequent review and the use of an emergency use authorization, we have, in our guidances, insisted upon the fact that there be a very robust and enhanced safety monitoring system after an emergency use authorization, should that occur.
We’ll be using a variety of techniques, including the standard techniques, but added techniques to actually collect those data, including looking at electronic health records, which, of course, protecting privacy and protected health information, but also looking at claims data. We’re going to be having an enhanced system and that’ll be in collaboration with our great partners, the Centers for Disease Control and Prevention.
Marshall: After that vaccine is hopefully approved for emergency use, we are hearing distribution within 24 or 48 hours. How quickly can we really see this become available to the public? What is the realistic timeline on when that first line, oftentimes health professionals, will get this vaccine?
Hahn: What’s under FDA’s control obviously is our processes and procedures for evaluating the emergency use authorization application. What I can tell you is that we’re working very closely with our other U.S. government partners, as well as the manufacturers, and to the extent allowed by law we’re sharing information to help inform decisions regarding exactly the questions that you’re asking.
We want to make sure that this handoff that occurs to the U.S. Health and Human Services and CDC after an authorization occurs as quickly and, certainly, accurately as possible based upon our decision. We’ll continue that work, but that question regarding the subsequent prioritization and distribution really is best asked of the partners, U.S. government, and the states that are going to be responsible for it.
Marshall: And it’s still such a small group of people who will end up getting this vaccine if it is given emergency use authorization, if the other ones come forward. It’s not a silver bullet. We still need to exercise all those public health measures and prevent the spread. Are we overpromising Americans who are excited about this?
Hahn: Serena, so you make a real good point here. I think we, based upon the public reports, are optimistic about what we’re seeing. If, in fact, the data support 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%, 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.
Marshall: Dr. Hahn, I think everyone would want to know, when will you get it?
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.
Marshall: Great. Thank you so much for your time. We really appreciate it. I know everybody is very anxious about this. Having someone break it down and let us know what the FDA’s planning to do is always helpful. Thank you, Dr. Hahn.
Hahn: Thank you, Serena. We’d be happy to come back.
Marshall: That’s it for this week’s episode, our premiere of Track the Vax. Join us in the coming weeks as we’ll talk to those leading the charge, from government officials to the pharmaceutical companies like Pfizer and Moderna, as well as those responsible for distribution. We’ll even meet 60-year-old Kelly Peck.
Kelly Peck: To be honest, since COVID-19 started I would say, “I’d stand on my head to make this go away.”
Marshall: She signed up for one of the phase III trials.
Now, don’t forget to subscribe to Track the Vax on MedPage Today, Apple Podcasts, Spotify, or wherever you get your podcast, and make sure to rate and review us. Follow us on Twitter, Instagram, and Facebook @TracktheVax. Send us your questions, concerns, and let us know what you want to know when it comes to a COVID-19 vaccine. Until next week, I’m your host, Serena Marshall. Join us where we will continue to “Track the Vax” to what comes next.