NIH Director on the Coronavirus Response: ‘We're Not Done Yet Here in March of 2021’

Dr. Francis Collins is serving under his third consecutive president as director of the National Institutes of Health, which has been at the forefront of combating the novel coronavirus pandemic for over a year now. In addition to working on vaccines and testing, the agency is also looking at the long-term effects of the virus. 

“I would not have guessed a year ago that this could have been done in this timetable and with this level of success,” Collins said on three vaccines––from Pfizer/BioNTech, Moderna and Johnson & Johnson––having emergency use authorization from the Food and Drug Administration.

He also praised his staff at NIH and the hard work they’ve done over the last year under difficult circumstances. Yet “our demands, our urgent requirements to push the science forward have not really lessened,” he said. “We're not done yet here in March of 2021. We are seeing the emergence of these variants that are causing concerns that they might make this pandemic go on longer than it should,” as well as the long-term effects of contracting COVID-19, which “we have to juggle with the best science we can bring to the table.” 

Government Executive spoke with Collins on Friday via video call. The interview has been edited for length and clarity. 

The federal government's response to the pandemic is now over a year old. We're coming up on the year mark for the lockdowns. Can you talk about, from a federal standpoint, what have been some of the biggest successes and either some of the biggest challenges or failures, in your opinion?

Well, first of all, it's astounding that we are here a year later with now three vaccines that have been tested rigorously in large-scale trials. And the results have shown safety and efficacy beyond what we might have dared to hope for. And they are now approved by the FDA for emergency use, and people are getting immunized, over 100 million doses have now been distributed across the country. I would not have guessed a year ago that this could have been done in this timetable and with this level of success. So that is just downright astounding. That is a huge credit to an army of hard-working scientists in both the public and the private sectors, and a whole lot of organization through things like [Operation] Warp Speed, and a partnership that I helped build with industry called “ACTIV” [Accelerating COVID-19 Therapeutic Interventions and Vaccines] and a lot of money that the taxpayers, through the Congress, provided ... to do something like this at unprecedented speed and scale.

In terms of things that didn't go so well, you know, I think when we were trying to develop an approach to treatments for COVID-19, because you not only need to prevent it, you also need to have something to help people who are already sick, that was a challenge to get started. When I looked at that circumstance about a year ago, our clinical trials were a bit scattered, there was no organizing, prioritization plan. And again, that took a couple of months of hard work to pull people together and agree that it just wasn't going to be ideal to have many flowers blooming here, we really needed to have a plan. Ultimately that came together with the formation of multiple master protocol driven clinical trials and trial networks that could test therapeutics in hundreds or thousands of patients in an efficient way. From that, we have made real advances in terms of identifying things like monoclonal antibodies for outpatients that seem to be capable of keeping people out of the hospital and even saving lives. 

It's also been challenging, though, because many of the things that we tried for treatments didn't work. Many of them had promising anecdotes that came along with them, hydroxychloroquine being most prominent of those. And yet, when you subjected them to a really rigorous, randomized, placebo controlled double blind trial, which is the only way you really know, it turns out they didn't work. Of course, we needed to know that too. Or we would just be wasting people's time and money on things that are useless instead of trying to find something better. 

Going back to vaccines, two vaccines have mRNA technology. I believe there's been research on this going back to 1990, but these are the first two vaccines to use this. Can you talk about the significance of that?

It's incredibly exciting that this strategy, utilizing mRNA to build a vaccine, worked and worked spectacularly well for both Pfizer and Moderna, giving rise to efficacy levels of 94% to 95%, which is much higher than I think any of us thought would be possible with any kind of vaccine, not to mention a brand new approach. But that's what we have now. It is important to point out this didn't just happen because of some stroke of genius in the middle of the night a year ago. That progress in mRNA vaccines is built upon more than 20 years of hard work in basic science, much of which wasn't necessarily considered as all that important or relevant at the time. 

Katalin Karikó, the Hungarian-born scientist who had this dream, had trouble getting funded back in the 1990s and only [succeeded] after she hooked up with Drew Weissman at the University of Pennsylvania and ultimately figured out how to get past the big barrier, which was that mRNA can be inflammatory, you have to figure out how to do something to modify it enough that it still codes for protein, but it doesn't set off a firestorm of inflammatory response. That's what they came up with. And then it started to look plausible, but that was still 15 years ago. It took a lot of investment, hard work, dreams, hopes, and commitment to ultimately get to the point where we were able to see this happen. NIH had a huge role in that. We had been working with mRNA vaccines and with the company Moderna, thinking that this might be something we would need for SARS or maybe for MERS. 

And then January of 2020 came along. And the virus that was causing serious trouble in Wuhan turned out to be a coronavirus and they knew right away what to do to design that vaccine. This is one of those amazing stories because as soon as the sequence of the viral genome was posted by Chinese scientists, the scientists at our own vaccine research center went to work and in 48 hours designed the vaccine that I now have in my arm from Moderna because they had all that experience to build on. And within 65 days that was already in a phase one trial. And by July, it was in a phase three trial. And by December, there was the data and FDA was saying, ‘Yep, that's a good one. Let's start distributing.’ Amazing story.

Switching to a managerial question, your agency has over 15,000 employees. How have you been working to keep up productivity and morale amid the pandemic as well as having one of your top officials, Dr. Anthony Fauci, be under somewhat of an attack from Republicans and others, including the former president? 

I have an amazing team that I get to work with. Everywhere from people working at the bench to people like Dr. Fauci, who are both running an infectious disease institute and also being a public health spokesperson who's always telling the truth and unflinching even when he gets negative feedback from various sources. It's a privilege to work with Tony. And of course, I have worked with Tony for 27 years, since I've been at NIH. So we know each other pretty well. We talk almost every night about exactly what has happened that day and what plans we need to make for the next day. So yeah, he is an incredible leader. 

But across this amazing workforce, called NIH, there are so many heroes and people who have been absolutely flat-out working as hard as humans can for the last year, recognizing that every day counts when we're talking about a disease. It's taking lives, thousands of them every day. Everything from the fact that we run a research hospital where patients come and they come to us pretty much because medicine has failed them, they wouldn't be coming to the NIH Clinical Center, unless they were ready to sign up for a clinical trial of some sort. All of those staff have to be there to take care of them. And we have had plenty of COVID-19 patients in our hospital as well, to try to take care of them as best we could. Then they're all the people who take care of the animals, who take care of the facilities and the researchers trying to work at the bench. It's been a tough year. Absolutely. We had to pretty much send everybody home except for those who are involved in direct patient or animal care back about a year ago and asked everybody to try to figure out how to telework. 

About half our workforce is still teleworking, the people who are able to do so. Those are folks managing the grant reviews or the grants management or other administrative roles that are really important, but can be handled [from home]. I guess I'm one of them. I'm talking to you from my home office in Chevy Chase, about four miles away from NIH. I only get back to the campus about once every week or two. Most of what I'm doing I'm doing from right here. It does kind of work after a while, but I miss the gatherings of people in the same room where you can share an idea or a smile, maybe even a hug, that would be nice, too. We've been deprived of all those things. 

And of course, I particularly have sympathies for those who are called upon to work harder than they ever had, but they're at home and they have kids to take care of and other duties that are just loaded up on top of their shoulders. I hope all those people do get a sense of just how heroic they are. Because they certainly are. I think our morale has certainly taken a bit of a hit just because people are exhausted. But on the other hand, I think everybody recognizes that they're engaged at NIH in a noble enterprise that has a mission to save lives. So you don't have to wake up in the morning and wonder whether your work matters.

But people are just exhausted and maybe even burned out in some instances and I feel like we have to try to take account of that. At the same time, our demands, our urgent requirements to push the science forward, have not really lessened. We're not done yet here in March of 2021. We are still seeing 60,000 or 70,000 new cases every day. We are seeing the emergence of these variants that are causing concerns that they might make this pandemic go on longer than it should. And all of those are things that we have to juggle with the best science we can bring to the table.

Kind of going off on that point, you've recently received a $1.15 billion allocation of funding to study the long-term COVID effects. Can you talk a little bit about what that initiative is and what you hope to accomplish with it?

The cruelty of this virus seems to know no bounds. It's not bad enough that this virus is capable of infecting people so easily and even being spread by people who don't have symptoms, which makes it very hard to stop by public health measures. It's not bad enough that many of the people it affects are ill and those who already have chronic illnesses who come from groups with health disparities are hit hardest. Now it's even bad enough to cause some of the folks who get this illness not to get better as they expected in the two or three weeks most respiratory viruses are limited by. Long COVID, or as we're calling it PACS, which stands for post acute sequelae of coronavirus, is a relatively common outcome and it doesn't even seem to be limited to people who were really sick with the acute illness. Even people who had relatively mild disease and didn't end up in the hospital, some of them just don't seem to be getting better and we don't know why. We don't seem to see evidence that the virus is still there in their system. But yet something about the virus’ presence has triggered a long-term consequence, whether it's in blood clotting, or whether it's in the immune system. We don't know. 

So we just announced a major $1.15 billion effort over the next four years to enroll at least 20,000 people who have had COVID-19 and to see what exactly happens and what are the triggers for this to last a long time? Who is most susceptible? And most importantly, how could we prevent it from happening? And how could we treat those people who are already suffering from long COVID? Right now, it's really a black box. We’ve got theories, but we need data to try to begin to sort this out. And so this involves no less than 20 of our 27 institutes. This is going to be all hands on deck in a pretty unprecedented large-scale cohort analysis to get answers to this vexing problem.

My last question is non-COVID related, I guess it could be in a sense, but a few days ago, you issued a statement about structural racism and biomedical research. Can you talk about why you decided to do it and the surrounding circumstances to educate our listeners and readers a little more?

Absolutely. 2020 will be remembered not just for COVID-19 and the devastation created across the world, but also for the realization, following the killing of George Floyd, that structural racism is a reality in the United States of America, and that our more than 400 years of racism, which began with slavery and even before that, with the treatment of Native Americans, is a history that we have not really gotten past. It influences our own biomedical research community in ways that we maybe have preferred not to look at, but we need to look at. 

As a consequence of that realization and recognizing that we need to do better in terms of our own diversity in our workforce, which still tends to be limited, as well as needing to revamp our whole approach to research on health disparities to focus more on the fundamental causes of such disparities, and on interventions to change those things, we brought together a group of about 75 people, many of them people of color, from different parts of NIH, some rather junior scientists, some senior folks and we inspired them to work together to come up with some recommendations about what we could do. Those ultimately got presented to my advisory committee to the director last Friday for them to review the recommendations at a public meeting. They accepted all of them and, hence, Monday of this week, we put out a summary of those and a director's statement, from me, documenting the fact that we are serious about this, and this is not going to be just words; these are going to be actions. We are going to change our approach to structural racism, admitting the role we've played in it, accepting the need to express apologies, as I have done to those who have been put through discriminatory experiences, and then we're going to change that and make this into a better future.

Those are all my questions, is there anything else that you think I should know or be aware of?

Oh, there's so many things that we could have talked about. I mentioned a bit about therapeutics, and about vaccines, I didn't talk about diagnostics. Another big project that we have been pushing since last April, is to try to develop even better ways to do quick turnaround point of care testing of people to find out who's infected with this virus and with a very novel approach, where NIH basically took on the role of a venture capital organization. We invited those inventors who had good ideas about this, to bring those forward, we threw them into what we called a “shark tank,” with experts to try to see whether they had an idea that could work if it was scaled. And for those that look reasonably promising provided them with resources to do so. And now today, if you look at where testing is happening, and what kind of technologies are being used, [we have] seen a big shift from the lab, sort of centrally located analysis, which tended to require two or three days to get the answer back to these point of care analyses, which many of which came out of our program called RADX for rapid acceleration of diagnostics. So we're pretty proud of that. We are now looking at how that might even be moved into the home as the real next area where we need people to get information so that they know whether they should go to work that day or not. We're about to test that in a significant pilot study. So, that's also been a consuming passion and, well, it should be.