How COVID Vaccines Were Developed so Quickly

John Whyte, MD, MPH; Michelle McMurry-Heath, MD, PhD

Disclosures

December 01, 2020

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  • Over 800 research and development programs are active around the world to combat COVID-19. Of those, 191 are focused on vaccine development.

  • Despite political and public pressure, researchers and vaccine regulators have pursued the science. Worldwide collaboration and focus have resulted in a record-breaking vaccine development timeline.

  • For the general public, a COVID-19 vaccine may be available in late spring or early summer of 2021.

  • New therapeutics to treat COVID-19 infection continue to be developed, such as antivirals aimed at attacking the virus head-on and medicines to aid in how the body responds to the virus.

  • Clinical trials need to represent a more diverse population. With COVID-19, we've seen a three times higher rate of mortality in the Black population and a two times higher rate in the Hispanic population relative to White persons. The Moderna COVID-19 vaccine trial had 35% enrollment of people of color, and Pfizer's had more than 40%.

This transcript has been edited for clarity.

John Whyte, MD, MPH: Welcome, everyone. You're watching Coronavirus in Context. I'm Dr John White, chief medical officer at WebMD.

In February, we really had nothing for COVID — no effective treatments and certainly no vaccine. Seven to nine months later, we have multiple therapies (some still undergoing review) and we have several vaccine candidates. But there's a concern of many people, perhaps even you, that we're moving too fast.

To help provide some insight, I've invited my friend, Dr Michelle McMurry-Heath. She is the president and CEO of the Biotechnology Innovation Organization (BIO). Dr Michelle McMurry-Heath, thanks for joining me.

Michelle McMurry-Heath, MD, PhD: Thank you for having me, John. It's a pleasure to be here.

Whyte: I also want to point out that Michelle was a colleague of mine at the US Food and Drug Administration (FDA) and has a lot of experience in terms of the regulatory process. Let's start off with a story of innovation, particularly with vaccines. Many people are concerned about their safety and the efficacy. 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 we can have confidence that when the vaccine is available, it's okay to take?

McMurry-Heath: Those are very sound questions and 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. At the Biotechnology Innovation Organization, we started a COVID tracker when the pandemic first emerged. 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. Of those, 191 are trying to develop new COVID vaccines. We've had an incredible number of shots on goal, and that has made a huge difference.

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

Finally, it's important to note that this is not a new development that started at ground zero. We really saw years of scientific advances being applied to this pandemic. We've had incredible leaps of knowledge in the past 5-10 years, and all of that progress is being applied to this application. So there's a reason for the speed.

At the same time, we want to make sure that we're doing everything we can to assure the public that these products that come out will be safe. We've been advocating that the 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. We've been assured that that's the case.

Whyte: Is it a failure of effective communication? Because someone could say, "I've heard that vaccines take a decade to develop, not 10 months." In many of the vaccine candidates, we're using new technology and RNA. We are able to do studies quicker because there is lots of virus out there, and in some ways that has 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?

McMurry-Heath: Oh, it absolutely is. Let's face it — there have been a lot of different cooks in this kitchen. There have 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 past 9-10 months can sometimes take years, if not decades. Our most recent record for developing a new vaccine was 4 years for the mumps vaccine. It's historic that we're to the point of seeing two vaccines within sight of the finish line just a few short months into this.

Whyte: How do you respond to people who are saying it's too good to be true? Why have we lost confidence in science?

McMurry-Heath: That's a question I wish I knew the answer to. I think it comes from decades of us not respecting and investing in scientific education, and 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. 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 that now the public gets to see it firsthand, so it's important that they understand that that is to be expected. Our knowledge and our evolution around COVID have changed tremendously in these past 10 months because so many people have applied themselves to trying to understand what's going on.

Whyte: Take out your crystal ball. Many 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?

McMurry-Heath: Our estimation has not changed since the early summer. We really think it will be late spring, early summer of 2021. That may seem soon, depending on your perspective, but often it seems way too far away. Let's face it — the loss of life that we've witnessed this year has been breathtaking. It's heartbreaking to know how it's impacted so many families, not just in the US but around the world. And so a vaccine can't come a day too soon. While we're likely to see emergency use authorizations in the next 1-2 months, the widespread use of the vaccine, or the ability to get it at your local doctor's office, will probably be April or May of next year.

Whyte: There may be logistic challenges as well with all of this in terms of the temperature that some vaccines must be at.

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 are concerns about the number of people that will be willing to take the vaccine. In terms of therapeutics, there has been success there, with monoclonal antibodies, remdesivir, convalescent plasma, and steroids. What's going on there?

McMurry-Heath: 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. 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 they already have COVID. We have seen some therapeutic successes earlier than our vaccine successes. So you're absolutely right.

Just last week, hearing that Eli Lilly's antibody cocktail had received emergency use authorization was incredibly encouraging. I think we'll continue to see the 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 therapies at their disposal.

Whyte: Something you and I talked about when we both were at the FDA was how to enroll more women and more people of color in clinical trials — not just for drugs, but also for 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 in clinical trials, recognizing that there could be some variability of drug response based on sex, race, age, and ethnicity? Are we doing enough? You have some initiatives on that.

McMurry-Heath: I'm so glad you brought that up because it's such a critical area. To answer 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. For many diseases (not just COVID), we don't fully understand how the pathophysiology or how the disease may differ between different racial and ethnic groups or between genders.

For example, in COVID, we've seen to date three times the rate of mortality from COVID in the Black population and two times the rate for the Hispanic population relative to White persons. This is not about whether they catch COVID more easily; it's about once they have it, we seem to have people of color dying more readily. So it's 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.

We launched our BIOEquality agenda in August, and the first tenant of that was around ending health disparities and improving participation in clinical trials. We worked hand-in-hand with our member companies to make sure that their trials in the COVID space were very diverse.

I'm happy to say that Moderna had 35% people of color enrolled in their clinical trial for the vaccine. In the Pfizer vaccine trial, they had over 40% people of color. Amazing effort has been applied, and it's yielding results. But long-term, we need to ask ourselves about 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.

Whyte: Well, part of that is also having more people of color who are researchers, physicians or PhDs. Can I ask you to share your own personal story? How did you become interested in medicine, and what was your journey?

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

Whyte: It was genetic.

McMurry-Heath: I don't know whether it was genetic or early training, but it was definitely indoctrination. My mother, who's about to turn 80, would sometimes take me along as she'd do home health visits. She had the black doctor's bag that she would carry into different homes when she did house visits and those sorts of things.

I think all of us who've had the privilege of working at FDA have been able to see the power of public health in action, really committing to figuring out what are the policy limitations to bringing healthcare to people.

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 nothing like what you see in your typical science class." So I called all of 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. I fell in love with the process of asking a question that had never been answered before. That's really what science and policy is all about. I love that process of discovery. As I went along in my scientific training, I became more focused on how science could be more relevant for more people. 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.

Whyte: Where do you think we'll be 6 months from now?

McMurry-Heath: I can tell you where I hope we'll be. I hope we will have an 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. That's where I hope we'll be, and I have faith that we're getting closer and closer to it every day.

Whyte: I think we're all hoping that as well. Dr Michelle McMurry-Heath, I want to thank you for providing your insights and 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 devices. Thank you for taking the time today.

McMurry-Heath: Thank you, John. It's such a pleasure to see you again.

Whyte: And thank you for watching Coronavirus in Context.

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