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The "breathtaking" speed of the development of multiple COVID-19 vaccines is unprecedented.
That speed did not compromise safety and efficacy, however. In fact, the COVID-19 vaccines are probably some of the best studied in history.
Federal agencies and industry collaborated early on in the pandemic — known as the ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) partnership — to prioritize and organize clinical trials for potential COVID-19 therapeutics.
The National Institutes of Health (NIH) used a venture capitalist Shark Tank–like model to empower industry to pitch their ideas for better point-of-care COVID-19 testing. Of 700 applicants, 28 finalists are contributing 2.5 million tests a day, including two home-based tests.
In early March, Dr Collins apologized for the structural racism in biomedical research and announced a new NIH initiative called UNITE to end structural racism and racial inequities in the scientific community.
This transcript has been edited for clarity.
John Whyte, MD, MPH: Welcome, everyone. I'm Dr John Whyte, chief medical officer at WebMD. Today I have a very special guest, Dr Francis Collins, director of the National Institutes of Health (NIH), who is the only director to serve three administrations. Dr Collins, thanks for joining me today.
Francis S. Collins, MD, PhD: I'm glad to be with you, John. Looking forward to the conversation.
Whyte: Were you surprised by the speed of vaccine development? You've been in research for over 30 years. When have you ever seen anything developed so quickly?
Collins: It has been breathtaking. When we were looking at this situation in early January of 2020 and trying to imagine how we could speed this up, a lot of thought went into trying to figure out ways to get rid of the downtime and try to anticipate all the ways that we could plan and prepare as if it was going to work. I did not believe that it was going to be possible to have, not one, but two vaccines receiving US Food and Drug Administration (FDA) emergency use authorization in December of 2020 — 11 months. That's just absolutely unprecedented, about five times faster than this has ever been done before. Much credit to the amazing scientific team that made this possible, building on this messenger RNA technology, which had never previously been taken all the way to an approved vaccine.
Whyte: Given that rapidity, what do you say to listeners who say, "Dr Collins, I'm just a little bit skeptical. It seems too fast."
Collins: Yeah, I do hear that, and in retrospect, the "Operation Warp Speed" terminology that got chosen might have not been the best choice because it did sound a little bit like, let's crash through and not worry too much about whether we're cutting corners.
I want to assure anybody who's listening that corners did not get cut. If it was anything that really mattered as far as safety and efficacy, these are probably the best-studied vaccines you could imagine in terms of the scale of the trials that were done, the collecting of the data, the public disclosure of every bit of the details of the data from the trials, and then ultimately, the debating in a public session about whether or not these were safe and effective.
Look at all that. Don't worry too much about the term "warp speed." But on the other hand, we did have a public health crisis. People were dying. I don't think people would have wanted us to be on "Operation Slow Boat." We needed to do something in a fashion that was unprecedented in speed because the urgency of the crisis of a pandemic required it.
Whyte: It really is a story of innovation in vaccine development. Let's turn to therapeutics and talk about lessons learned over the past year. The acting commissioner of the FDA, Dr Janet Woodcock, and others have talked about learning that there are challenges in the clinical trial enterprise and community. Doing research in broader communities can be challenging, with duplication of results and poorly designed trials. What have you learned over the past year in terms of how we need to improve clinical trials?
Collins: Well, Dr Woodcock and I have been close partners in the course of this past year. So many of the things that she points to, I would agree with. When I looked at where we were in March of 2020 — as it was pretty clear that this was going to be a very serious pandemic, and we not only needed vaccines, we needed treatments — it was pretty much a scattershot scene at that point in terms of what trials were being done. Many of them quite small, maybe not powered well enough to give you a dependable answer. Most of them focused on a very short list of compounds, particularly hydroxychloroquine, and did not go after what might have been a more promising set of therapeutic agents.
It was critical that we had to do something to try to organize this effort and do it in a more rational way. That was the opportunity to reach out to Janet Woodcock and to Stephen Hahn at the FDA to figure out how we could bring the Centers for Disease Control and Prevention into this. And most important, how we could reach out to industry and all the companies that were developing therapeutics and vaccines and say, "Hey, this is the time for us all to be around the same table. Let's figure out how to prioritize which compounds ought to be tested first. Let's organize our clinical trials so they're not scattershot. Let's figure out how to write master protocols so that as soon as you're ready to put a therapeutic into a trial, you've already got the design. You know it's going to be rigorous, and that if it works, FDA is going say, "Okay, we'll approve that."
Those things don't usually happen, and that's what this ACTIV partnership had made possible, with 20 pharmaceutical companies, many government agencies and academics, and all managed by the Foundation for NIH. That has been an amazing and unprecedented experience — all coming together in about 2 weeks in April of last year, and now being the main engine for doing therapeutic trials across everything, from inpatients to outpatients, from antivirals to immunomodulators to anticoagulants. It's all in there.
Whyte: So lots of progress. Vaccines are great, but we also have to have treatment options because COVID could still be around, and not everyone may get vaccinated. Let's talk a little bit about what you said, that we need to have a Shark Tank–like mentality as we come to funding trials. Other folks will say, "That's not the role of government." It's almost like a venture capitalist approach. Is that what we need to be thinking in terms of this, to really compete in a new way with new measurements?
Collins: I think that's another lesson from COVID-19. I'm not sure NIH in the past would have embraced that kind of model of basically stepping up as a venture capitalist. We did that particularly for diagnostics. It was clear back in April of 2020 that most of the testing was being done in big-box laboratories. The test would therefore have to be obtained, shipped off to the lab. The results wouldn't come back in a good way in less than 24 hours, and sometimes it was longer.
What we really needed were tests that were at the point of care, that give you a result in 10,15, or 30 minutes, and could be readily adapted to all kinds of settings. We didn't have the technology to do that, so we set up what we called a "shark tank" and we invited the inventors, small businesses, and academic labs: Bring forward your idea about how to detect SARS-CoV-2 in a nasal swab or a saliva sample. Show us what you've got. We'll throw it into this shark tank of experts — which were businesspeople, engineering experts, technology experts, scale-up people, manufacturing people, supply chain people, all the things you would need if you were going to make a big investment — and we'll see what comes through.
We started with more than 700 applicants, and we have 28 that made it all the way through this innovation funnel that are now contributing about 2.5 million tests a day because of this venture capital effort that we put together. By the way, that includes the first two tests that have been approved by FDA for home use, which is going to be quite a transformational change in the way we track this virus.
Whyte: Let's talk about the attack on science that we've seen over the past year — the attack on scientists. We have to be practical and call it for what it is. Do you think we're going to see some improvements as we start to talk more about data and science?
Collins: Well, I would hope so, but we have to look back. Before COVID-19, these issues were already in place, certainly in the area of vaccines — sometimes furious and often very emotional arguments about whether vaccines for childhood illnesses are safe, given all of the misinformation, conspiracies, and falsified information that have led people to believe there might be a connection with autism, which there absolutely is not.
So, we already had a lack of trust and a sense on the part of many communities that scientists are elitists who are maybe not telling you everything you need to know, or maybe they're driven (if they're in industry) by the profit motive. All of those things were the background upon which COVID-19 landed. Maybe it's not surprising that that furor came to the fore, especially as in our country, the politics and the way in which everything turned into a polarization scene played out here as well.
We're not anywhere near over that. I just saw a poll that said 49% of Republican men don't intend to take a COVID vaccine. That cannot be on the basis of data because the data are incredibly compelling, so it must be on the basis of politics and various media, including social media. It tells you that our nation has lost its way in terms of the ability to tell the difference between facts and opinions. If we don't recover that, if we don't recognize that our future depends on the fact that there is such a thing as objective truth, and it can be established by science, and then you can depend on it to make your own decisions in a wise fashion — I don't know. This is not a path that's going to be good for our nation if we don't recover our sense of exactly what the things are that you can count on. What are the things that you can look at and say, "Okay, that's actually true"?
Whyte: But Dr Collins, you talk about science, and many people are talking about the role of faith-based communities in addressing the science of vaccines and addressing vaccine hesitancy. As you talk about belief in science, I want to ask about the connection between faith and science. You recently said there's no contradiction between faith and science. You said there is harmony. Other people will say they're mutually exclusive — I've been listening to your podcasts on this recently. How do you reconcile the concept of faith and that of science?
Collins: Well, when I was an atheist as a graduate student, I would have said they're irreconcilable, and faith, basically, is irrelevant for modern life. Then I went to medical school and sat at the bedside of people who were dying and realized that there were some pretty fundamental questions here that science wasn't helping me with, like, why am I here? And why is there something instead of nothing? Is there a God, and does that God care about me?
Science is pretty much powerless to answer those questions. Either you decide that those are just out of order and you shouldn't be asking those, or you have to find some other way to pursue them. That's where faith comes in. To my surprise, as I began to explore that, thinking it would help strengthen my atheism, I instead became a reluctant convert, and I've been a believer since age 27.
In all of those 40-plus years, I have not encountered a circumstance where I see a conflict between the truth that I learn about spiritual things from my faith and the truth that I learn about nature from science. It's just really important if you're trying to answer a question that you figure out what kind of question is this, and which is the approach that's going to give me truth as a result.
Science is great at answering those questions about how things work. Sometimes it's not so great at saying why? Faith can sometimes step into that space. Admittedly, in our country especially, because the voices that people have primarily heard have come from the extremes of this spectrum of science and faith, there is a general assumption, like, oh boy, these folks just can't get along. But I don't think a lot of people feel that way. I wrote a book about that, and people are interested. There's a website, BioLogos. An awful lot of people are actually having this conversation.
Whyte: You helped create that website, didn't you?
Collins: I did, after the book came out and people wanted to keep the conversation going and I ran out of ways to answer emails. So we turned it into a remarkable community that now gets millions of hits every year from people who are really substantively interested in how you could be a serious person of faith and a serious scientist. And yes, you can.
Whyte: Well, this is a whole other discussion, and I know you're pushed on time. You've talked about these voices that we need to listen to, but the voices also have to look like other people; diversity is important. You recently issued an apology earlier this month for what you said is the structural racism that exists in biomedical research. You've been a proponent — we all know this — about how you wouldn't serve on "manels," these panels that are composed of all men, historically older white men.
Collins: Like me.
Whyte: What is the NIH doing to address this structural racism in biomedical research?
Collins: 2020 will always be remembered not just for COVID-19 but also for the way in which, with the killing of George Floyd and a variety of other egregious examples of how racism is still real in our society, we all had to come to grips with that fact, and that after 400 years, we have not solved these issues of inequities, particularly racial inequities that spread across all aspects of our society, including the biomedical research community.
You can't look at our circumstances and say, "Oh no, we're over that. " We had to admit that we have neglected to pay enough attention to this issue of structural racism and we needed to figure out how, both in terms of how we recruit and retain diversity in our own workforce, but also how we conduct research in health disparities and inequities.
How can we get more deeply into the fundamentals of why it is that your ZIP code is one of the strongest predictors of your health span? So, we've convened a very intensely interested and articulate group of experts, the majority of them people of color.
We listened hard over many months, and just a couple of weeks ago in a public session, we put forward a number of major steps we are going to be taking, both in terms of our research portfolio and how we manage our workforce. That will be coming out in a published form in another month or so for everybody to look at and tell us whether we've got it right. This is hard, but it's been too long that we've looked the other way.
Whyte: Well, Dr Collins, I want to thank you for taking the time today and for all that you're doing in terms of advancing the research enterprise — and for advancing clinical trials not only in COVID but in all conditions that we need to address. Thank you.
Collins: Thanks. It was nice to have this broad-ranging conversation with you.
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Cite this: NIH Director Discusses Vaccines, Science, Faith, and Structural Racism - Medscape - Mar 17, 2021.