NIH Director: ‘It Is Astounding What’s Been Done’ Regarding COVID-19 Vaccine | Voice of America - English
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VOA contributor Greta Van Susteren interviewed the National Institute of Health Director Frances Collins. Among the issues discussed are the COVID-19 vaccine and its development. Here is a transcript of that interview: Nice to talk to you, sir. Nice to talk to you, Greta. Well, we Americans know what NIH is and we're very proud of it but what is NIH? The National Institutes of Health, it's the largest supporter of biomedical research in the world. Basically, everything that the U.S. is doing in terms of research and academic institutions Institute's and our own intramural program is funded by the taxpayers through this budget, and I'm the director that's supposed to make sure it gets spent wisely everything from basic science to clinical trials. Diabetes, rare diseases, cancer, and of course right now, COVID-19, and that's what we are all about $42 billion a year. For you the research you do a lot, a lot of research, all research. What does the FDA do the Food & Drug Administration we hear so much about in terms of the vaccine? So, FDA is a sister agency we're both in the Department of Health and Human Services. FDA's job is to be the regulator and it's to look at some proposed new approach maybe it's a diagnostic test. Maybe it's a therapeutic, maybe it's a vaccine and to get all the data together and look at it and decide if it's going to be safe and effective, so we generally do the research trying to stimulate this kind of progress to happen and FDA decides whether it's safe for the public to start to use it in general way. All right, so we're waiting breathlessly for these vaccines and some are farther along like Moderna and Pfizer than others, but once it gets the green light from the FDA, who decides who will get it first? Well, this is a big day for that, basically the CDC has an Advisory Committee on Immunization Practices, ACIP, and it's their job to look at a circumstance where you have a vaccine that FDA has decided is safe and effective at least for emergency use, but there aren't enough doses for everybody to receive them on day one. So, who gets first in line. That's a big decision, it will include health care providers because we want them to be safe in their frontline experience and it will include people at high risk, particularly the elderly people with chronic illnesses. And that will get played out over the course of the coming months as more and more doses become available, but of course trying to protect the most vulnerable people first. I'm old enough to know to remember polio vaccine when it first came out, am is the distance was, how was that distribution decision made? Do you know? I don't know the total details -- initially there was a big trial to see whether it worked just as we have been doing with COVID-19 with these vaccine trials involving tens of thousands of people. Once it was decided that it was working, then there was an issue about how many doses can be made available and it didn't happen overnight. In fact, it took quite a long time, a year or two. In this instance, Operation Warp Speed has invested in doing the manufacturing of vaccine doses, even before we know whether it's one of these six or more than one of these six vaccines is going to work with the expectation that if one of them didn't, you'd have to throw those doses away happily now we have two that look as if they're very likely to win FDA approval in the next couple of weeks. And there are others just a little bit behind that may get approved in January, ideally, we may even have multiple different vaccines, each of which have 10s of millions of doses, and we could really start to reach out and get immunization to happen to lots of us, not just the most vulnerable people. Well, the vaccines, as I understand, talking to experts, is coming, very quickly. What has been the role of the U.S. government to sort of fast track this have gotten rid of some of the red tape or is it provided more funds or what's the role of the U.S. government? It is astounding what's been done here, Greta, because traditionally it takes eight to 10 years to develop a vaccine against a new pathogen, this has been done in less than a year. The U.S. government pulled all of the resources together to make sure that coordination was happening. operation warp speed made it possible also to get rid of some of those long delays that oftentimes vex the process where you go to phase one and then you have to wait many months before you go to phase two, all of those things were synchronized in an unprecedented way, but not by doing any compromising at all on safety these will probably be amongst the most highly tested vaccines ever in terms of their safety and efficacy and the good news is, the first two that are going to get looked at by FDA. In the coming weeks, look extremely good with efficacy over 90% which is better than most of us had dared to hope and safety record that also looks extremely good so we are in a good place to begin to see how we might get COVID-19 behind us but it's going to take a lot of months to get there for everybody. I don't want to hope or expect as we another virus coming down the road, but I assume that it's inevitable so --has the U.S. learned something new as government learn something like stripped away some of the red tape so that we can look forward in future times and that will take a shorter time to get a vaccine than eight or nine years? Absolutely. We've learned a lot, and we've documented all along the way ways that things can be done more efficiently and this. Our accomplishment of having vaccines that are ready to go into individuals in less than a year is certainly going to be the norm in the future and maybe we could even do it a little faster, although it would be pretty hard to go faster than this you just still have to run the trials and wait and see whether the vaccine works and you can only speed that up so much, but I do hope and I'm part of this decision and discussion that's going on right now that we don't slip back into complacency. Once we get past COVID-19 because there's another pandemic out there. I don't know whether it's five years from now or 10 years from now or next year, and it probably could be another coronavirus or it might be an influenza virus. And this is just the nature of our world and anybody who thinks over over that look at history, we're not likely to be. All right, Moderna, and Pfizer as I understand it, both have something called the sort of a science behind is something called messenger RNA, are they very different vaccines are very similar? They're quite similar basically messenger RNA is the part of a nucleic acid that codes for protein. And this is a very clever way to make a vaccine where you basically synthesize that messenger RNA that has the right information in it, inject that into Muscle, Muscle goes, Oh I know what to do with messenger RNA I'll make a protein. And so it does, and it makes the spike protein, which is the stuff that decorates the coronavirus and those spike proteins, the immune system says oh no you don't and makes an antibody to them. And it's very quick. That's why Pfizer and Moderna are the first two out of the gate because the messenger RNA approach can be started almost immediately upon the time the viruses isolated. So it is a new approach, it looks extremely promising, it is going to be transformational I think for vaccines for all kinds of things because it looks like it's really worked, and this is the first time it's been taken all the way through to these Phase Three trials and FDA approval. One of the issues is gonna be distribution and the Pfizer requires that the vaccine be kept so called which refrigeration incredible refrigeration. What, why is it if they're so similar the Moderna and the Pfizer one needs to be kept so much colder which is going to inhibit some of its distribution? Yeah, it's a great question and all our people puzzled if it's so similar. Moderna can just be kept in a regular freezer and can even be in a refrigerator for a week and it'll be fine there too. But the Pfizer one, it's wrapped in a different kind of envelope, it's not just the messenger RNA by itself it's sort of put into an envelope of lipids and the Pfizer liquid envelope is very tense sensitive to warming up, which is why it has to be kept at this minus-94-degrees freezer, which isn't available a lot of places. Moderna's envelope is less concerned about temperature issues and so it can be stable in a more forgiving way. Coming along I should say the next set of viruses next set of vaccines bay by Johnson and Johnson, and by AstraZeneca. Those are going to be also much more forgiving as far as the temperature requirements. The so-called cold chain will not be nearly as demanding for those which will be great, especially for places that don't have a lot of freezer capacity like some of the low- and middle-income countries that are also going to need these vaccines. Do Astra Zeneca and the Johnson & Johnson have the same messenger RNA approach to a vaccine are they different vaccines? They're using a different approach one that has been tried and true and other situations takes a little longer it basically captures the energy of a different virus and adeno virus just as a carrier a delivery truck and uses that also to deliver the coating for this spike protein so it's making the same kind of response happen in the immune system, but it's getting it in in a different way. And this is something that's been done successfully for Ebola so we know this vector system is likely to be safe and effective. The Johnson and Johnson one also is a single dose which will be very much easier to manage whereas Pfizer and Moderna requires two doses one on day one and other one three or four weeks later, it's a little more complicated to set that up, we'd love it if we had at least one of these that was just one dose and you're done. You know I read early on, I've been following this virus like everybody else is that there was a possibility or some discussion about six months ago about a bridge vaccine which would be polio or TB, that if you got that vaccine the live vaccine that it would rev up your immune system, essentially, and fight out fight off COVID. Was there ever any sort of thought or did NIH look at that was that just a bridge it's like health care workers in the short run? We did look at that, we have a group called active ACTA IV accelerating coronavirus therapeutic interventions and vaccines and they surveyed the entire landscape of opportunities for therapeutics and vaccines and they looked at this, they thought if we had nothing else, there might be a little enhancement of your immune response sort of in a general way by one of these other vaccines, but compared to the specific vaccine that we now see in front of us, the effect would probably not be nearly as powerful so we decided to focus on what really was needed something that would be 95% effective as opposed to a general benefit that might give you a few percentages of improvement but wasn't really going to change the course of this pandemic in such a big way as what we need right now. When I get, when I've got a tetanus vaccine I've since then. Over the years had to get boosters. Do you anticipate that with or can't you tell now whether if you get this vaccine that at some period, sometime in the future you need a booster. I wish we knew more about that, because this is a new virus, we really don't know how durable, your immunity is going to be, we don't know for people who got the COVID-19 infection naturally, could they get it again if we knew more about that we have some sense about whether the vaccine would last for years and years. It's going to take some time to tell. it might be that the virus also mutates over time and ultimately new version appears that the vaccine and your natural immunity don't quite work anymore. So we might have to have not just a booster but a slightly redesigned the vaccine to cover whatever this coronavirus is trying to do to us. Those are all uncertainties in the best of all worlds. This will last a very long time, I'm guessing boosters are probably going to be needed. I just hope they aren't too frequent tetanus we could live with a 10-year timeline if that's what it takes, but we just don't know. I spoke to Dr. Fauci who works at NIH, several times and very early on and we were talking about vaccines and he said he would be very hopeful with a with a protection of 50, and that he was thrilled with 70. Now we're reading you know 94,95 ish, is that you know the flu isn't that good the flu vaccine doesn't do that well- with this with this new approach messenger RNA can we expect that we'll relook at like flu vaccines or is it just a completely different category, and that we can sort of up the protection there? I think it's not so much the technology for the vaccine. it's the nature of the actual virus. influenza has this nasty ability to change its coat, every year in a very substantial way. And no matter how clever your vaccine is if the virus is like completely changed its appearance the vaccine won't give you immunity anymore so I don't think we'll be able, through this approach to solve the influence issue there may be other ways to do that by a Universal influenza vaccine. We just seem to be fortunate though that coronavirus is particularly susceptible to the vaccine. I didn't dare to hope that we'd end up with efficacy over 70%, and to see these first two coming through at 95% is incredibly exciting and provides a great deal of hope that we will be able to get through the next few months and be able to put this in the rearview mirror, but we've got a long way to go. With the influence of changing its code so to speak so often, in looking at the coronavirus with the virus that you saw last February, March is at the same virus you were looking at now or is it likewise trying to change its code. It's pretty much the same. It's an RNA virus, it does change its spelling when it gets copied and there's lots of bad virus out there that has the chance to change its spelling and we've seen two or three instances where there's a new version that maybe has a little bit of an advantage maybe it's a bit more infectious and so that new version starts to rise up in its frequency so far nothing that we're alarmed about in terms of affecting the likelihood that the vaccine is going to work, but we have to watch that closely and again over the course of many years it's possible, a new a new version might arise that the vaccine doesn't work very well for and then we'd have to redesign the vaccine. You know I'm old enough to remember landed on the moon that was such a huge game changer, you know, for the United States, I likewise see this I mean moving so quickly in a vaccine something that is, you know, that is terrorizing the world I mean it really is quite extraordinary isn't it. It is, Greta, and you know 2020 has been just a terrible year for so many people with the suffering and death of this terrible pandemic with economic distress it's caused. And I must say, for science, it has been a challenge like one we've really not quite had to deal with before for life science, and it is really wonderful to see the way science has come forward. All of the partners in industry and academia and government, working together in an unprecedented way not worrying too much about who's going to get the credit to make these things happen at a scale and a timetable that was unimaginable before and I hope that's being noticed and I hope a lot of young people watching that might have the same reaction they did when we went to the moon saying, That looks like fun. I want to be part of that too because we have a lot more science to do in the future. Well I guess we could use more help from the people who are watching the science I think it stopped congregating in huge, you know, huge herds of people, because you know this is all hands on deck, sort of, so to speak. Yeah. And that is something to really keep in mind even though we are seeing this promise of a vaccine that's going to get us through this, it will be many months before we have enough people in the community immunized that we could stop worrying about transmission. So for the coming months. People need to double down on those careful measures -- wearing your mask watching your distance washing your hands those three W's more important than ever, and nobody should imagine that this is about somebody else and not about them even a young person who imagines that they're pretty immortal and even if they get this virus, they're going to be fine and they could be the next super spreader. and if you care about the people around you, your neighbors your parents, your grandparents, then it's got to be up to you to all of us to take that responsibility seriously. We have holidays coming where the risks are going to go up, if people relax their guard. I'm not going to have Christmas with my family this year first time didn't have Thanksgiving with my family this year either first time, but it's the way that we all have to wrap our arms around responsibility for 2020, as a year of, we got to get through this. And we got to get through it together. And I suspect that NIH is also working on treatments, new therapies to to fight this to the for the person who does get COVID. We are indeed and that's an intense part of how I'm spending my time and we've made some real progress there. We have the drug remdesivir, which is an antiviral that helps people who are quite sick in the hospital. We have dexamethasone a steroid that also helps people who are the sickest of the sick in the ICU. And we have monoclonal antibodies developed from people who've survived COVID-19 basically purifying their antibodies that help them recover and giving them to other people, showing real promises, especially if you give those early to high risk individuals, and we have other trials that are going on right now that may very well yield up other immunosuppressives or antivirals that can add to this compared to where we were back in February and March where we didn't have much of anything we've now got quite a menu of therapeutics and survival has certainly improved for people who get very sick with this but it's still a very serious disease we've lost 275,000 people. And this is a scary few months that we're looking at with wintertime, and with the vaccine not yet as widely available as it will be by the summer. you talked about Remdesivir the other antiviral is to reduce the viral load, you get those when you get to the hospital, and you're very sick. When I get the flu. I call the doctor calls in a prescription for something called Tamiflu and I get a pill and could just go to the drugstore sir I headed off at the past before I get so sick to the hospital is are there efforts being made to make these antivirals, not when you get real sick and end up in hospital but to back it up when you first get sick? Yes, there are efforts of that sort, so far, none of those antivirals have yet been approved for outpatients. remdesivir is an intravenous drug which makes it not so convenient for people who are not in the hospital, what is approved for outpatients what I mentioned a minute ago. these monoclonal antibodies from Lilly and from regeneron, which while they're in somewhat limited supply can absolutely greatly help people who are at high risk, just got diagnosed get the monoclonal in the first three days after symptoms, and you can greatly reduce the likelihood that person ends up in the hospital. Is dexamethasone so the last question I have is dexamethasone, which is the steroid, which is what you get in the hospital and when when you've really been when you've got a huge problem -would prednisone which is a steroid that is prescribed by pill. Would that be at all helpful in in minimizing the risk of how sick you get or not? It's all about timing, Greta, and these steroids are basically keeping your immune system from overreacting and causing more damage than help and that is often what seems to happen with the sickest people in the ICU, who've developed really bad lung disease and other systemic problems. At that point the virus is almost gone but the immune system is going crazy. And by dialing it back sort of turning down the thermostat for your immune system you can help people survive. On the other hand, you need your immune system early in the course of a viral infection you want it to be out there cracking down that virus and taking care of it so it's probably a bad idea to give prednisone or dexamethasone to somebody who's early in the course save that for the people who are laid in the course and are still really sick, and you may help them. Because under the theory that your immune system you don't want to tell your immune system not to work. What you want to do is what, when you get to the point where the virus is gone is you don't want your immune system to overwork and give you another problem and that's when the steroid comes in to tell your immune system stop. Right? Exactly, exactly. And we're looking at some other immune suppressive that might be even more specific than dexamethasone, which is a pretty broad acting anti-inflammatory drug. Maybe there's a more subtle directed way to do this that would even be better and that's under study right now, several trials. Also, one more thing here in that space. We know that those people who are really sick also developed a problem with too many blood clots in the lungs, clots in small vessels. And so using an anticoagulant to actually thin the blood may also help people survive and that's another big study that's underway right now it looks pretty promising. Which is so interesting because older people tend to be on those types of drugs for heart, you know, medication so that they some of them are already on that. That's right, they may be somewhat protected ironically against the worst aspects of COVID-19 if they're already in the blood thinner, but a lot of people aren't, and those folks may need one if they're in that very serious circumstance where blood clotting is starting to be part of the problem. Well, as Dr. Birx told me is you can't get the virus if you don't go near it. So, you know, keep your hands clean masks and stay out of groups, you know, that's, you know, stay away from people. Absolutely, especially indoors where we know the spread is so easy and unfortunately that means a lot of family gatherings which tend to be indoors with people eating and not wearing masks and I'm fearful that with this holiday season upon us. People will be too careless about that. We are not out of the woods here, we have a very challenging few months ahead, and the best things we can do while cheering for the science and waiting for our turn to get the vaccine is to practice those three W's absolutely wear your mask, watch your distance wash your hands. What about surfaces boxes that come to the house, you know people who come into your house and we may not be near, but they touch the surface. You know, we worried more about that early on, I am there is some possibility of viral spread there, but it does not seem to be a major effect so at my house we stopped wiping off all the boxes that came to the front door. After seeing some of the data that's probably a very low risk, compared to all of the other things which is basically these droplets, that are being expressed by all of us when we speak. Certainly, when we sing. All of those things where that's the most likely place to catch this illness. Doctor thank you very much and thanks to NIH and you know for, you know, I think the world's very grateful for all the work that all of you do. Well, it's a privilege to be able to be the guy trying to manage this effort with such an amazing team of dedicated scientists and we are going to get through this and science is going to be a big reason why. Thank you, sir.