NIH Launches Effort To Speed Up Development Of COVID-19 Treatments

Apr 17, 2020

In an bid to help speed up the development of potential treatment options and a vaccine for COVID-19, the National Institutes of Health on Friday announced a new public-private research partnership.

The new initiative will be spearheaded by the NIH but also include the Food and Drug Administration, other parts of the federal government and a list of 16 companies that includes some of the biggest players in the pharmaceutical industry. Among the companies participating in the effort are Pfizer, Johnson & Johnson and Merck.

"We need to have all hands on deck from every sector to speed up the process of identifying those treatments that are going to work and to get the vaccines also developed, tested, to make sure they're safe and effective in the maximum possible speed," said Dr. Francis Collins, director of the NIH, in an interview with NPR's All Things Considered.

The announcement comes after President Trump and public health officials on Thursday unveiled new guidelines for states to begin reopening the country. Health experts say that in order to safely do that, there needs to be more testing, contact tracing and better drugs to treat COVID-19. Ultimately, for things to truly return to normal, an effective vaccine is needed.

Collins said there are already two vaccines in phase one trials, and behind that, a series of more than 40 other vaccines being developed as well. But he cautioned that the public should expect failures along the way.

"Somewhere in there may be a winner, even if most of them are losers," he said.

Collins also provided an update on testing of antiviral drug, remdesivir, and shared his thoughts on Dr. Anthony Fauci, the high-profile director of the National Institute of Allergy and Infectious Diseases.

Here are excerpts from the conversation.

There's a lot of buzz about an antiviral called remdesivir.

Remdesivir is certainly, I think, at the top of most people's hopeful list, but not yet proven. Just to report, yesterday although not yet peer reviewed, that in a monkey model it looked as if this did provide benefit for COVID-19. ... We're running a human trial with now 800 participants enrolled more quickly than expected. We will know, I think, in the next two to four weeks whether it worked or not.

[A] question about one of the most prominent faces of U.S. anti-virus efforts, Dr. Anthony Fauci ... Have you come under any pressure to fire him?

Absolutely not. He is a wonderful public servant, an amazingly smart infectious disease expert. He and I have a nightly phone call every evening to catch up on what's happened with his life down at the White House and mine trying to manage the NIH. He's the best ally I could ever have.

Listen to the full interview on All Things Considered at the audio link above.

Copyright 2020 NPR. To see more, visit https://www.npr.org.

AILSA CHANG, HOST:

It's been a month and a day since the White House announced 15 days to slow the spread. That was the plan to use social distancing to try to stop the coronavirus. Of course, those 15 days have been extended. An additional 30 were added, and social distancing will almost certainly extend well beyond that. Meanwhile, hundreds of thousands of Americans have become sickened with COVID-19. Tens of thousands have died.

MARY LOUISE KELLY, HOST:

Last night at the White House, President Trump and public health officials unveiled a plan to begin to reopen the country. To safely do that, there will need to be a lot more testing, contact tracing, better drugs to treat COVID-19 and, ultimately, a vaccine. Well, developing those drugs and a vaccine are two of the things our next guest is thinking about. Dr. Francis Collins is director of the National Institutes of Health. Dr. Collins, welcome to ALL THINGS CONSIDERED.

FRANCIS COLLINS: I'm glad to be with you, Mary Louise.

KELLY: Well, let's start with those efforts to speed up a COVID-19 - options for treatment and a vaccine. You announced today that you are launching a public-private partnership to get this done. Would you give us the short version of why that is the way to go?

COLLINS: We need to have all hands on deck from every sector to speed up the process of identifying those treatments that are going to work and to get the vaccines also developed, tested to make sure they're safe and effective in the maximum possible speed. And to do that, it means bringing everybody around the same table.

So some 16 companies, the National Institutes of Health, the FDA, the foundation for NIH and other parts of the federal government have all gotten together to say, we're just going to do this, and we're going to roll up our sleeves, and we're going to work 24/7 to speed up that process to get those answers.

KELLY: So public, private, U.S., international - which prompts the obvious question, do you have the authority to compel all of these players to work together? And I guess I'm thinking - just take the big pharma companies - Johnson & Johnson, Pfizer - that are that are involved. These are companies used to working in competition, not used to working together.

COLLINS: They are. But, you know, they see this as a unique moment where there's really no alternative but to have everybody contribute what they can. I've had the head of a pharmaceutical company say, you know what? This is such an urgent issue. If you have a therapeutic that another company made that needs to be tried out, I'll offer my clinical trial network for it to be tried. We just need to succeed. I've never seen anything quite like it. And this is exactly the right attitude we need if we're going to win against this pandemic.

KELLY: What about when it doesn't work? It seems part of this has to be persuading all of these stakeholders to share when something they're working on fails. I mean, everybody likes to talk about success; the reverse is a bit trickier.

COLLINS: You are so right about that. And there will be a lot of failure. Let's be clear about this. Most of the things we will try to treat this disease might have looked good in some sort of cell culture model. But when you get them into human beings, they won't work, or they'll end up having some toxicity.

That's why we need to have such an organized effort, where if there are maybe a dozen good ideas out there, we make sure all dozen get tried - parallel, not sequential - so that somewhere in there there may be a winner, even if most of them are losers. We just got to get this going.

KELLY: So let me turn you two to where things stand. Start with the efforts to find a drug that could effectively treat COVID-19. There's a lot of buzz about this antiviral called remdesivir, which you're funding, studies of it and others. What is actually looking promising?

COLLINS: Remdesivir is certainly, I think, at the top of most people's hopeful list but not yet proven. Just a report yesterday - although not yet peer reviewed - that in a monkey model, it looked as if this did provide benefit for COVID-19.

KELLY: Just monkeys for now, not human trial?

COLLINS: That was the monkey result because we already have the result. We're running a human trial with now 800 participants, enrolled more quickly than expected. We will know, I think, in the next two to four weeks whether it worked or not.

KELLY: OK. And what qualifies as worked?

COLLINS: To show that you actually provided benefit by comparison to a matched set of patients who didn't get the drug done in a randomized controlled trial so that even the patients and the doctors don't know who got the drug and who didn't. That's the only way we can really be sure whether something worked.

KELLY: And just to make sure I'm clear before we move on from remdesivir, you're - when you say you're looking at couple of weeks, maybe several weeks, in terms of results, that's for humans or for monkeys?

COLLINS: That's for humans.

KELLY: OK. What about efforts on a vaccine? Where does that timeline stand?

COLLINS: Well, already, there are two vaccines that are in phase 1 trials. The first one - one that NIH, through its vaccine research center, developed along with a company called Moderna - and that looks quite good so far. But that's a phase 1 trial that's basically looking to see whether it's safe. We just announced yesterday that in addition to young, healthy people, we're now involving volunteers who are older because we want to make sure it works in that space, too.

There are behind that, though, a series of more than 40 vaccines being developed - some early stage, some getting closer to the point of human application. The trick here is also, I think, to fund several of those in full-bore support, so you don't know which one's going to work and you don't want to wait to find out that something failed to start another one behind it. So then the question is how fast can you go.

And that's where this new collaborative effort that we've been talking about, which stands for accelerating COVID-19 therapeutic interventions and vaccines - that, of course, spells ACTIV...

KELLY: Of course.

COLLINS: The V is vaccines. And we are very much working with the FDA to see if there's a way to speed up the process of going from phase 1 to a sense that it actually works and then scaling up the manufacturing.

KELLY: Right. And how safe does a vaccine in this case have to be? Obviously, perfect would be the standard. But there are always trade-offs, I imagine, between perfection and speed. And with such urgency here, is some kind of vaccine better than no vaccine?

COLLINS: Depends, I guess, on who you're going to offer it to. If you're going to offer it to everybody, boy, it needs to be really safe because this is something you're asking healthy people to take on board. If you have a circumstance where you have very high-risk people where, in fact, you could tolerate a little bit more of a side effect, you might still want to use that vaccine for people with chronic illnesses who are older. But ideally, you want a vaccine that makes people resistant to the disease and doesn't make them sick.

KELLY: And if and when there is a vaccine, will you have input into who gets it first?

COLLINS: I think that will be a big decision on the part of public health system. But obviously, you want to give it first to the people at higher risk of getting infected. So health care workers are likely to be first in line.

KELLY: One last question for you about one of the most prominent faces of U.S. antivirus efforts - Dr. Anthony Fauci. You are his boss.

COLLINS: (Laughter) Yes, I am.

KELLY: Have you come under any pressure to fire him?

COLLINS: Absolutely not. He is a wonderful public servant, an amazingly smart infectious disease expert. He and I have a nightly phone call every evening to catch up on what's happened with his life down at the White House and mine trying to manage the NIH. He's the best ally I could ever have.

KELLY: Yeah. I'm asking, of course, because of the president retweeting a tweet with the hashtag fire Fauci. And he does have what, at times, is an uncomfortable job. It's his job to tell the president, sir, there are things you can't do.

COLLINS: And Tony Fauci is incapable of doing anything other than telling the truth, as he sees it, from his long experience. And I think that's why a lot of people have such respect for him. I certainly do.

KELLY: So he's not going anywhere, to your knowledge.

COLLINS: I have not been pressured to do anything other than to support him and cheer for him, and I will continue to do that.

KELLY: Francis Collins - he is head of the National Institutes of Health. Dr. Collins, many thanks for your time. We really, really appreciate it.

COLLINS: You're welcome. It was nice to be able to talk to you. Transcript provided by NPR, Copyright NPR.