Coronavirus in Context: Vaccine Development and Public Confidence

[MUSIC PLAYING] Welcome, everyone, you're watching Coronavirus in Context. I'm Dr. John Whyte, chief medical officer at WebMD. When you think about it, in February, we really had nothing for COVID. No effective treatments, certainly no vaccine, and now, seven, eight, nine months later, we actually have multiple therapies, some still undergoing review. We also have several vaccine candidates. But there's a concern of many people-- perhaps you-- that we're moving too fast.

So to help provide some insight, I've asked my friend Dr. Michelle McMurry-Heath, who is the president and CEO of the Biotechnology Innovation Organization. Dr. Michelle McMurry-Heath thanks for joining me. How are you?

MICHELLE MCMURRY-HEATH: I am wonderful. Thank you for having me, John. It's a pleasure to be here.

And I also want to point out that Michelle was a colleague of mine at FDA and has a lot of experience in terms of the regulatory process. But let's start off with, in many ways, it's a story of innovation, particularly in the vaccine. But many people are concerned about the safety and the efficacy of the vaccine. It seems too fast. Can it really be that good?

Help us understand what the process has been for vaccine development and your own insights into, how do we have confidence that, when the vaccine is available, that it's OK to take?

No, those are very, very sound questions and obviously questions we've been hearing quite a lot. It's incredibly important that everyone get line-of-sight to the incredible science that has gone into the place we find ourselves today. So we at the Biotechnology Innovation Organization started a COVID tracker when the pandemic first emerged. And we've been tracking all of the scientific progress globally. And it is amazing.

We have seen, to date, over 800 research and development programs launched just to try to combat COVID. 191 of those are just trying to develop new COVID vaccines. So we've had an incredible number of shots on goal and that has made a huge difference.

The other thing that's made a difference that showed up in our tracker is that we've seen collaborations like we've never known before. International collaborations, collaborations between small companies and large companies, importantly, collaborations between government and for-profit companies, really trying to work together to end this scourge. And that has been hugely influential.

And then finally, it's important to know that this is not just new development that was starting at ground zero. We really saw years of scientific advances being applied to this pandemic. And so we've had incredible leaps of knowledge in the last 5 to 10 years, and all of that progress is being applied to this application. So there's a reason for the speed. But at the same time, we want to make sure that we're doing everything we can to assure that the public knows that these products that come out will be safe. And so we've, at the same time, been advocating that FDA be allowed to do their work in the absence of politics. And that they keep the same high standards that they've always had. And we've been assured that that's the case.

Is it a failure of effective communication? Because someone could say, you know, I heard vaccines take a decade to develop, not 10 months. But in many of the vaccine candidates, we're using new technology-- MRNA. We actually, in some ways, are able to do studies quicker, because there's lots of virus out there, in some ways that have benefited clinical trials. But there seems to be a lot of miscommunication in terms of the science of the vaccine. Do you think that's a valid criticism?

Oh, it absolutely is. And let's face it, there have been a lot of different cooks in this kitchen. There've been lots of different points of view weighing in on how it should be done or how it will be done. But the good news is that the scientists and the regulators have really stuck to their guns. They have pursued the science doggedly. And they have not wavered in the face of political pressure, or even in the face of public concern or demand. They're really just trying to let the science speak for itself. And that's incredibly important.

But the public's not incorrect that what they're watching unfold in these last 9, 10 months can sometimes take years, if not decades. Our most recent record for developing a new vaccine was four years for the mumps vaccine. So it's historic that we're to the point that we're seeing two vaccines within sight of the finish line just a few short months into this.

But how do you tell people who are saying, it's too good to be true? Why have we lost confidence in science?

Yeah, I mean that's a question I wish I knew the answer to. I think it comes from decades of us not respecting scientific education, not investing in scientific education, and also shortchanging scientists and their ability to communicate about what they do and bring the public into the process of scientific research.

One of the things that I think has been most elucidating about 2020 is the ability to see how science is sometimes one step forward, two steps back. You know, sometimes you see something that looks like it's going to work, and then it fails. That is de rigueur for science. That is what happens absolutely every day when you're working at the lab bench or you're working in the clinic. It's just now that the public gets to see it firsthand.

So it's important that they understand that that is to be expected. And our knowledge and our evolution around COVID has changed tremendously in those last 10 months because so many people have applied themselves to trying to understand what's going on.

Take out your crystal ball. A lot of people are giving predictions of when vaccination will be available to the general public. What's your best estimate of when such a vaccination plan will be available?

MICHELLE MCMURRY-HEATH: You know, it's interesting-- our estimation has not changed since the early summer. We really think it will be late spring, early summer of 2021. And that sometimes seems soon, depending on your perspective. But often it seems way too far away. Because let's face it, the loss of life has been breathtaking that we've witnessed this year. And it's heartbreaking to know how it has impacted so many families, not just in the US, but around the world. And so it can't come a day too soon.

But while we're likely to see emergency use authorizations in the next one to two months, before you see widespread use of the vaccine or the ability to get it at your local doctor's office will probably be April, May of next year.

And there may be logistic challenges as well, with all of this, in terms of the temperature that some vaccines must be at-- not all of them.

Yes.

Let's turn to therapeutics and treatment options, because some research will say that's where the real action is. We're all waiting upon a vaccine. And there's concerns about the number of people that'll be willing to take the vaccine. But in terms of therapeutics, there's been success there. Monoclonal antibodies, remdesivir, convalescent plasma, steroids-- what's going on there?

Well, it's definitely a more complex picture, because there are lots of different ways to try to fight the virus. There are antivirals that really try to attack the virus once it comes into the body. And then there are the medicines, the small molecules that are trying to adapt the way the body responds to the virus once you're infected. But all of this bucket of therapeutics is designed to help people once you already have COVID. And we have seen some early successes, earlier than our vaccine successes.

So you're absolutely right. Just last week, hearing that Lilly's antibody cocktail had received emergency use authorization was incredibly encouraging. And I think we'll continue to see this steady march of new therapeutics becoming available. So that as clinicians are treating those critically ill patients at the bedside, they'll have more and more tools at their disposal.

Something you and I talked about when we both were at FDA was, how do we enroll more women, more people of color in clinical trials, not just for drugs, but also medical devices? What progress have we made in terms of making clinical trials more representative of the population, which ultimately they serve? And ensuring diversity of clinical trials, recognizing there could be some variability of drug response based on sex, race, age, ethnicity. Are we doing enough? And you have some initiatives on that.

So I'm so glad you brought that up, because it's such a critical area. And to answer your your last question first, are we doing enough? No, there has to be much more that we can and should do to make sure that our clinical trials are representative of the patients that we hope to treat. And it's because we don't fully understand, for many diseases, not just COVID-- how the pathophysiology-- or how the disease works-- may differ between different racial and ethnic groups or between genders.

So for example, in COVID we've seen to date, three times the rate of mortality-- that is death-- from COVID in the African-American population and two times the rate for Hispanic population, relative to white patients. So this is not about, do they catch COVID more easily? It's about once you have it, we seem to have people of color dying more readily. And so it's very, very important that anything we're testing in the COVID space-- a vaccine or a therapeutic-- really have representation from those groups in the studies, so that we can be assured that it will work for all people.

And we at BIO launched our BIOEquality Agenda in August. And the first tenant of that was around ending health disparities and improving participation in clinical trials. And we worked hand-in-hand with our member companies to make sure that their trials in the COVID space were very diverse. And I'm happy to say that for the Moderna trial that we've just recently heard some preliminary results from, they had 35% people of color enrolled in their clinical trial for the vaccine. And in the Pfizer vaccine trial, they had over 40% people of color.

So amazing effort has been applied, and it's yielding results. But we need to ask ourselves long-term the bigger picture about how we make clinical trial participation more appealing to all people, so that we can have a good representation in the science and the data.

Well, part of that is also having more people of color who are researchers, who are physicians, who are PhD. So if I can, I want to ask you, can you share your own story-- your personal story-- how you became interested in medicine? And what was your journey?

Sure, of course-- so I was born and raised in Oakland, California, by two public health leaders. And so I got to see, from a very early age, how transformative it was to bring health care to impoverished and vulnerable populations.

It was genetic.

I don't know if it was genetic or early training, but it was definitely indoctrination. But my mother, who's about to turn 80, would sometimes take me along as she'd do home health visits. And she had the black doctor's bag that she would go into different homes with when you did house visits and those sorts of things. So there's a power of public health. And I think all of us who've had the privilege of working at FDA have gotten to see the power of public health in action and really committing to figuring out, what are the policy limitations to bringing health care to people?

And then when I was in college, I just happened to have a teacher's assistant who said, when you guys go home for the summer after freshman year, you should work in a lab, because it's nowhere like what you see in your typical science class. And so I called all the college professors at my nearby university when I was home for the summer.

And one of them took pity on me and let me come into the lab and play with the pipettes. And I fell in love with the process of asking a question that had never been answered before. And that's really what science is about. And I actually think it's also really what policy is about, as well. And I love that process of discovery.

And as I went along my scientific training, I just got more and more focused on how science could be more relevant for more people. And that's where I found my real passion at the intersection of science and policy, where we can make science more tangible to everyday lives.

Where do you think we'll be six months from now?

Can tell you where I hope we'll be. I hope we will have a amount of optimism that just seems tragically distant, sitting here today. I think we'll be seeing the application of cutting-edge science to transforming not just our health, but our economy and our nation's trajectories in a way that it probably never has before. And we'll be putting this pandemic behind us.

But that's where I hope we'll be. And I have faith that we're getting closer and closer to it every day.

I think we're all hoping that as well. So Dr. Michelle McMurry-Heath, I want to thank you for providing your insights. I want to thank you for what you've been doing through the span of your career, in terms of public health and advocacy as well as drug development and device development. So thank you for taking the time today.

Thank you, John, it's such a pleasure to see you again.

And thank you for watching Coronavirus in Context.