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NIH Director on FDA ‘being careful’ in clearing Moderna vaccine for kids 12-17

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Dr. Francis Collins, Outgoing NIH Director, joins Yahoo Finance’s Anjalee Khemlani to discuss Covid-19 vaccine production, drug development research, and misinformation surrounding Covid-19 vaccines.

Video Transcript

ALEXIS CHRISTOFOROUS: Dr. Francis Collins has been at the helm of the National Institutes of Health, the country's largest public research agency, for more than a decade. That's the longest a director has remained in that position. He's here today joining Yahoo Finance's Anjalee Khemlani to reflect on his leadership during the pandemic and how drug research has evolved over time. Anjalee.

ANJALEE KHEMLANI: Thank you, Alexis. And welcome to Dr. Francis Collins. Dr. Collins, I want to get to all the reflections that you could possibly have in those 12 years. But first, some news that we got from the FDA just moments ago, delaying its decision on the doses for kids 12 through 17-year-old for a Moderna shot. I just wonder on that, if you could address that for us quickly, I know that Pfizer, BioNTech also had similar concerns, but why on more of the concern on Moderna right now? Could you explain that to us?

FRANCIS COLLINS: Sure, I think it's a matter of timing. Again, Pfizer's vaccine was approved for kids 12 and up several months ago. Now we have a little more concern and experience about the myocarditis, pericarditis rare side effect of these mRNA vaccines primarily in young males. And I think the FDA is just being careful here. They've had the data from Moderna on 12 to 17-year-olds for a few months. They've been studying it.

I think they just are announcing they want a little bit more time to assess this and be sure that the benefits and the risks come out on the right side of approving this. So I don't know that that should cause anybody in alarm. We are watching closely this issue about myocarditis. The good news, it's very rare, and the other part of the good news is, it is virtually always reversible in a short period of time. But it's still something that we want to pay close attention to.

ANJALEE KHEMLANI: Absolutely, definitely will keep our eyes on that. But it also provides a great segue for one of the things I really wanted to address with you, and that's the concerns of global vaccine equity. Of course, NIH was instrumental in funding not just Moderna's vaccine and the development there, but also some of the others that have now made it out through authorization and approval. There's so much discussion about intellectual property and waiving and what is really needed.

We saw earlier in the pandemic companies like Gilead providing non-exclusive voluntary licenses. Moderna itself saying it would not enforce patents. But it seems to not be enough. Where do you stand on that? And what tools does the US government have to really help really grow the amount that we're giving to the world?

FRANCIS COLLINS: Well, it's a really important question. And a lot of us are spending a lot of time on that. And for me, having been NIH director for more than 12 years, global health has been one of my highest priorities. So I really want to see this work. I think probably one has to recognize, though, that the main way to increase manufacturing of vaccines right now is in the facilities that are already doing this. It takes months, sometimes years, to establish brand new vaccine manufacturing facilities and get them actually credentialed to be sure they're safe.

So if we want to see the billions of doses that are needed, particularly for low and middle income countries, as quickly as possible, we ought to do everything possible to ramp up the production in the companies that are already doing this. And that's certainly something the US government is investing in, in a big way.

You may know that the Biden administration has already to committed over 1 billion doses of vaccine to get to particularly low and middle income countries. 175 million of those have been actually shipped and many more to come. 500 million from Pfizer the end of the year, and another 500 million next year. That is more than all the rest of the countries of the world together have committed to.

And there's COVAX, of course, and we, the US, have donated $4 billion to COVAX, again, more than any other country. COVAX ran into trouble because they were counting on the Serum Institute of India to be a major supplier of vaccines. And that all got slowed down by the crisis of the delta variant explosion in India back in the spring. So, everybody's struggling hard to do this.

I would like to see a lot more vaccine manufacturing capability in low and middle income countries, particularly sub-Saharan Africa, and doing a lot to try to see what could be done there in South Africa and Senegal and Rwanda and maybe other places. But one should not underestimate the timetable involved in getting those up and going. It will not provide the immediate solution that we'd love to have in the next few months.

ANJALEE KHEMLANI: Absolutely, and I know the companies have already announced plans for either standing up manufacturing there or plans to eventually stand up manufacturing there. So definitely will keep an eye on that. But this also ties into something that I know you've had to deal with over the last several years.

And that's the role of a public funded research and how that plays into the broader ecosystem of drug development and drug pricing. In fact, I know in the last several years, you've had to deal with that. But I just wonder moving forward, do you see, especially with gene therapy and more complex therapies coming to the fore, is there a room for conversation still in that space? And where do you see the role of taxpayer money, as it relates to drug pricing?

FRANCIS COLLINS: Well, first, let's look at the way in which the American drug discovery and development program has worked over the last 20 years and recognize that it's a remarkably successful kind of ecosystem with the contributions from academic research, much of it funded by the government through the National Institutes of Health, but then working with biotech, working with industry. Taking advantage of intellectual property in order to inspire investments that otherwise would not happen, we have led the world in the development of drugs, therapeutics, vaccines now, and it's not by accident.

At the same time, costs are high and we have to figure out ways to try to drive that down. For gene therapy, which you mentioned, we've been working now with multiple companies and the FDA to try to see if there is a way to move forward, particularly for very rare diseases, where there's not going to be a lot of commercial interest, to see if there's a regular way to set up gene therapy trials so that each one doesn't have to be a one-off. And that would make it cheaper and faster to actually get these trials going on.

And I think we're on a path towards being able to do so, particularly with the FDA's involvement. And they've been very open to the idea, coming up with a more templated way to do the regulatory part, which is often the thing that causes a lot of delays. They don't want to be the delay creators anymore. And my hat is off to the FDA people in gene therapy. They really want to see this work.

ANJALEE KHEMLANI: We'll definitely keep our eyes on that. Well, let's pivot to a look back now. You know, you've been at the helm of the agency for more than 12 years through three administrations now. And there's obviously been a lot that has happened in that time, but the pandemic has really been, I think, a test for a lot of leaders, both in the private and public sector. Looking back, are there things that you have seen now in hindsight that weren't obvious to you at the start of the pandemic that you wish you could have seen?

FRANCIS COLLINS: Well, it has been a wild ride over these 12 years and especially the last 22 months with COVID-19. I think it is important to point out that as this pandemic struck, the scientific community rose to the occasion in truly dramatic and unprecedented ways, working with industry without worrying too much about who's going to get the credit, making it possible for vaccines to be approved for emergency use in 11 months, which is about 5 times faster than has ever happened before.

I had the chance to co-lead an effort with industry 20 different companies, NIH, FDA, CDC, to see if we could organize our efforts to test therapeutics and find out what works and what doesn't. And now, in master protocols run in large scale trials, we have tested more than 20 different therapeutics. That's how we know monoclonal antibodies work. But we know they need to be applied early. They don't work once you're really sick in the hospital. That's how we know remdesivir works. That's why, right now, we're testing some of these antivirals.

And that has been a pretty remarkable effort because it's gone so quickly. We set up a program called RADx, Rapid Acceleration of Diagnostics, to see whether we could tap into small business ideas about testing for COVID-19 and put them through the paces to see what was really going to work and then give them funds to scale that up. There are now 35 technologies out there in clinical use. Many of them are point of care or even home, like the ones you can buy in the pharmacy, because of that program.

So what I learned is, if there's a pandemic and if you really are in a hurry, and if you can pull all the partners together, you can get stuff done about five times faster than anybody thought possible. And let me say, that's one of the motivations now for the proposal of a new component of NIH called ARPA-H, kind of doing what the DARPA agency does for defense, but applying it to health-- that's the H in ARPA-H. And I'm pretty excited. If we get the authority and the funding for that, we could turn the page here in terms of being able to do a lot of very youth-driven projects in a big hurry that would bridge this gap from basic science to clinical application.

ANJALEE KHEMLANI: Absolutely, I'm so glad you brought up the testing. I know that something that's really important as we see travel open back up. And people are still worried about the fact that there aren't that many tests on the shelves just yet, but this goes back to, I think, building up capacity for sure.

One of the things that you've commented on-- and I know you've been asked about a lot-- is, misinformation and disinformation and the role that it has played in sort of the way that the US has been able to respond to the pandemic. You've said culture wars are killing people. And Dr. Peter Hotez has called it anti-science aggression. Have you been surprised by how much that evolves throughout the pandemic? And how much did you see it evolve throughout your 12 years?

FRANCIS COLLINS: I have been surprised and especially so just in the last couple of years. And the combination of mixing politics with public health, which is not a good idea, and the fact that everybody is stressed out-- I am, too-- by COVID-19, and social media emerging in a way that, frankly, has not been helpful where it's possible for misinformation or even disinformation to spread much more rapidly in social media than the actual truth. And people are trying to figure out what's going on.

And so many people have been taken in by rumors and conspiracies and just plain lies that has made it hard for them to size up what they're supposed to do. And I don't blame those people for being confused. I do blame the people that are distributing the false information. They're killing people. We got to wake up to this. There's not just one epidemic in our country. One is the virus, the other one is this disinformation campaign. And if we don't figure out how to deal with that, our society has a difficult future ahead of it.

ANJALEE KHEMLANI: Certainly. Well, Dr. Collins, I wish we had an hour to speak with you, but we'll leave it there for now. Thank you again for joining us. All the best in the rest of your plans. I know you're not going to be very far from the NIH. You're going to still be within the entity. So, again, thank you for the time.

FRANCIS COLLINS: Glad to be with you. Yeah, I'm heading back to my lab, doing experiments, and glad to be helpful in any way I can.

ALEXIS CHRISTOFOROUS: Thank you so much.

ANJALEE KHEMLANI: Appreciate it. Back to you, Alexis.

ALEXIS CHRISTOFOROUS: Thanks. Thanks, Anjalee and Dr. Collins. Great conversation there. We appreciate your time.