With the coronavirus pandemic dominating the news, GLG recently met with three medical and public experts for their views on several aspects of the crisis, including those related to vaccines and public health policy. The three experts are:

Dr. Rachel Sherman, an infectious disease physician who most recently served as principal deputy commissioner at the Food and Drug Administration. As the FDA’s most senior policy advisor, she oversaw several high-priority programs and offices. She joined the FDA in 1989 and was a driving force in HIV drug development during the height of the AIDS crisis.

Dr. Michael Osterholm, Regents Professor, McKnight Presidential Endowed Chair in Public Health, and Director of the Center for Infectious Disease Research and Policy at the University of Minnesota. A global authority on infectious diseases and public health, he is a member of the National Academy of Medicine and author of Deadliest Enemy: Our War Against Killer Germs. He was Minnesota’s state epidemiologist for over 20 years and served in various public health advisory capacities for four presidential administrations.

Dr. Nicole Lurie, a strategic advisor to the CEO of the Coalition for Epidemic Preparedness and Initiatives (CEPI) and senior lecturer at Harvard Medical School, is a member of the research faculty at Massachusetts General Hospital and a Professor of Medicine at George Washington University School of Medicine. She served for eight years as Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, where she led the department’s response to public health emergencies ranging from infectious diseases to natural and man-made disasters. Earlier, she was the Paul O’Neill Professor of Policy Analysis at Rand Corporation.

Edited excerpts from our broader conversation follow.

Generally, where do things stand now?

Dr. Sherman: Certainly, we’re in an unprecedented time and in uncharted waters. The timing of some of what I think many people would agree are very unusual actions on the FDA’s part recently makes any speculation about what might the future might hold regarding the agency’s actions a bit difficult, especially with the election so close.

Dr. Osterholm: I’ve been in this business 45 years and nothing comes close to where we are now, and I think we have to be prepared for more surprises. While we have a need for urgent and unusual actions, science has to rule the day. It is objective, self-correcting, and what we must rely upon. That’s what we need to keep focusing on, because if science is not going to be the currency of the day, then how do we, as scientists, respond?

Two more things. First, we must remember that a vaccine itself is nothing until it becomes a vaccination. Ultimately, how we deliver a vaccine at the local and state level and how we deal with the complicated features of a rollout will be critical. It’s not going to be as simple as giving somebody a shot. It’s likely going to require two shots. How does that work? How do you keep track of that? I would urge that we keep a big-picture view of what’s happening at the federal, state, and local levels, because if any one of the links in that chain is broken, the whole chain is worthless.

Finally, the public must not be confused into thinking that somehow science is trying to hold back a vaccine. With 800 to 1,000 people dying each day in this country, we want vaccines as much as anybody, but those vaccines have to be as safe and as effective as possible. We can’t sacrifice safety and efficacy for speed.

Dr. Lurie: In my experience in managing all manner of public health emergencies, one of the things I’m most struck with is these events really bring people together. In this case, it seems as though we have, as a country, lost track of the fact that our common enemy is the virus, not one another. We’ve got to keep our eyes on the ball and end this pandemic, and the best and fastest way to do that is through public health measures and then with a vaccine.

We started a serious investment in platform technologies to make vaccines after a 2010 review of the medical countermeasure enterprise, and we’ve made unprecedented scientific progress since then. It’s not like the vaccine effort came out of thin air when COVID started. How tragic it would be if this amazing multibillion-dollar effort wasn’t allowed to produce the return on investment that is needed in ending this pandemic.

Finally, there are now all kinds of crazy conversations about whether or not a vaccine is safe. At the moment, we don’t even have a vaccine candidate. It would be absolutely tragic if a really great vaccine were developed and because of all the craziness out there, we couldn’t use it to end a pandemic.

Dr. Lurie touched on safety. Typically, the approval process for a vaccine is lengthy for that reason and for reasons of efficacy. What do you see ahead for a COVID-19 vaccine?

Dr. Sherman: Let’s start with the measles vaccine, which is our ideal vaccine because it is probably the most effective vaccine that we have to date. Measles doesn’t change very much. But this is not going to be a measles vaccine.

The flu vaccine, by way of contrast, is about 50% effective, because influenza changes. But while coronavirus has been around for a long time, this particular coronavirus is behaving differently from a more typical respiratory coronavirus. I think it’s very difficult to know, at this point, what level of efficacy we can expect from a vaccine. Since this is probably not going to be a measles-type vaccine, we go back to the point made earlier that the first line of control in this pandemic has to be public health measures — which is going to include how we distribute a vaccine if and when we get one.

Also, it’s always important to remember that vaccines are different from therapeutics. From my work in the very early days of HIV when patients were dying, we learned that the risk-benefit ratio when putting a novel therapeutic into a dying patient is different from the ratio for a vaccine, which goes into healthy people. There, the bar for safety is much higher, and not all vaccines are perfectly safe. Since we’re in uncharted territory with COVID-19, which is not behaving the way it “should,” so even though we’re in a rush, we must be careful. We should all learn from the influenza epidemic of 1918-20 and not repeat those mistakes.

As far as therapeutics are concerned, I’m very confused about why remdesivir has not been approved, based on what I’ve read. I don’t think the other drugs are as far along or have as much data. It’s not perfect, but in crises, one cannot have perfection. The drugs that I worked on in the early days of HIV are no longer used, but they kept some people alive long enough to get the better drugs.

Is there a rough timeline for the arrival of a vaccine?

Dr. Osterholm: Let me frame it this way: I can tell you that it will snow this winter in Minnesota, but I refuse to tell you whether or not there will be a blizzard on December 18. Similarly, I’m confident there will be effective vaccines with a relative level of safety that would merit their immediate use, but I don’t know when. The challenge we face is knowing when we will have sufficient data to weigh all the issues concerning safety and efficacy. Only then can we make a decision that is scientifically sound and also instills confidence in the part of the public. And let me throw this out, with the caveat that I have no crystal ball here whatsoever. If the vaccine that’s created is 50% effective — and I surely hope that figure is much higher — and only 50% of the population gets vaccinated, that means that only 25% of the population will be protected, which means there’s still going to be a lot of coronavirus infection out there. So we not only have to work toward a vaccine, but also plan for its use, as well as continuing to develop and support therapeutics.

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This article is adapted from the September 18, 2020, GLG webcast “COVID-19 Vaccines: Policy, Access, and Guidelines.” If you would like access to this teleconference or would like to speak with Drs. Lurie, Osterholm, or Sherman, or any of our more than 700,000 experts, contact us.