Masks. Lockdowns. Shuttered businesses. Hospitals strained beyond capacity.
Weary of the pandemic’s myriad disruptions to normal life, many Americans are pinning their hopes on a COVID-19 vaccine. But even if an effective one is developed, it won’t make the virus magically disappear.
On today’s episode of The Dose podcast, Dr. Margaret Hamburg, former commissioner of the U.S. Food and Drug Administration and a member of the Commonwealth Fund’s board, talks about the race to develop and deploy a vaccine.
“Even the world's most safe and effective vaccine won't make a difference if people don't trust it and won't take it,” she warns.
SHANOOR SEERVAI: Most of 2020 has gone by under the shadow of the pandemic, and people are growing weary of lockdowns and social distancing and this looming sense of uncertainty. Many of us are pinning our hopes on a vaccine, but this vaccine, once it comes into existence, isn’t going to magically make the pandemic disappear. I’m Shanoor Seervai, and on today’s episode of The Dose, I’m here with Margaret Hamburg, who goes by Peggy. Peggy is the former commissioner of the U.S. Food and Drug Administration, which is the federal agency that will ultimately approve a COVID-19 vaccine. Peggy is going to talk about what it’ll take to develop a safe vaccine, and then what it’ll take for all Americans and ultimately the entire globe to get vaccinated.
Peggy, welcome to the show.
PEGGY HAMBURG: Thank you so much. Glad to be here.
SHANOOR SEERVAI: All right. So let’s start with where we are in the race to develop a COVID-19 vaccine. Until very recently, the President seemed confident we would have a vaccine before the election, which is now just days away. And in fact, we do not have a vaccine. So what’s a realistic expectation on the timing of the vaccine?
PEGGY HAMBURG: Well, vaccine development against this new SARS coronavirus 2, the virus that causes COVID-19, has really moved forward at an unprecedented rate. It’s been extraordinary to see from the time in early January when the Chinese scientists first posted the genome of this virus and we understood what was causing this disease to the time that vaccine trials first began in people. And now to a point where there are just a very large number of candidate vaccines in development, and around the world, almost a dozen that are in the final stages of clinical studies. We’ve compressed a lot of what normally takes years into a very short period of time. And the key is not to cut corners in terms of assessing safety and efficacy but accelerate the process as much as we can.
So I don’t think that pronouncements from the President are what matters in terms of timeline. It’s where the science is and the study of these vaccines in people to assess their safety and their efficacy and the relative risks and benefits. But we are really making progress. And I’m guardedly optimistic that we’re going to start to get results from these large phase three clinical studies that will tell us which of the vaccines in development are going to make it over the finish line, at least for authorization on an emergency use basis in the context of this overwhelming COVID pandemic.
SHANOOR SEERVAI: So if we have to look into a crystal ball and guess, around when do you think we would have this authorized vaccine?
PEGGY HAMBURG: Well, nobody knows, but I think that by the end of the year on a couple of the clinical studies that are currently underway, we’re going to have some real data to look at. And that will be the basis of an authorization from the FDA, either for emergency use in targeted priority populations or a broader approval. Likely an emergency use will come first. But again, the science has to lead the way. And importantly, this has to be a very open and transparent process because there have been lots of concerns about whether things are moving too fast and corners are being cut in terms of safety and efficacy.
SHANOOR SEERVAI: You mentioned safety a lot. So what are the characteristics of a safe vaccine? What are we looking for?
PEGGY HAMBURG: Well, it’s important to recognize that with vaccines, unlike with drugs and many other medical interventions, we’re giving the product to people that are healthy to keep them safe from disease as opposed to treating a disease that’s already entrenched. And so matters of safety are always important with medical interventions, but especially so with vaccines and especially so when you’re talking about a vaccine to address a global pandemic where people not just across this country but around the world are going to be taking the vaccines. So it is important to really have a sense of both how effective are they? Who will they benefit? What dose? How long will the duration of protection be? What will be the extent of the protection? But also safety.
And once the vaccines are made available outside of the context of clinical trials to more and more people, in this case millions, hundreds of millions, we will need to continue to monitor, to do what we call pharmacovigilance, to look for any emerging safety concerns and assess them. And also to continue to better understand how the vaccines are working. Importantly, whether different vaccines work better for different subpopulations of people. And also we still need to learn about the level of protection that different vaccines may afford and the duration of that protection. Do we need to have multiple booster shots over time to keep up protection, or will the initial dosing be adequate? And we just don’t have those answers yet.
SHANOOR SEERVAI: Right. And I guess when we think about a vaccine, especially the first ones, they’re not going to be 100 percent effective. Everyone who gets it isn’t going to be protected from the coronavirus. Correct?
PEGGY HAMBURG: That’s right. I mean, sometimes people think that a vaccine means that you’re absolutely protected from getting infected, from getting disease. But there are very few vaccines that approach that level of protection. The measles vaccine is about 97 percent effective, and that’s probably the best of the bunch. Annual flu vaccine, as you may know, really varies season to season in terms of its effectiveness, its protection. And it can be as low as 40 percent, often 60, 70 percent, but it depends on the recipient and it depends on the season. And we expect that the early COVID vaccines, based on emerging but still preliminary data, will not be all that protective. The FDA has set as a regulatory guideline that it must be at least 50 percent effective. So that will make a difference, that will be significant in controlling disease, but it means that there’ll be many people who won’t be protected. And we actually don’t know whether the vaccine will prevent disease altogether. Maybe it will just lessen symptoms or the duration of disease.
SHANOOR SEERVAI: So this first iteration, let’s say it’s 50 or more percent effective, who are going to be the first people to get it? Because as you said, hundreds of millions need it.
PEGGY HAMBURG: I think everyone agrees that frontline health care workers need to be at the front of the line for vaccines. After that other first responders, but which first responders? What about other essential workers who may not be wearing uniforms, but are stocking grocery shelves and delivering packages? Certainly those at highest risk for disease, the elderly, those with other comorbidities or concomitant disease, those in congregate settings like nursing homes or prisons and homeless shelters, they are at higher risk and probably should be early on the priority list. And then we know that certain populations like Blacks and Latinx are disproportionately burdened by COVID-19. And so in terms of justice and equity and disease burden and public health, they too should go to get vaccine early on. So there needs to be a thoughtful process and clarity about how these allocations will be made and it should reflect public health and disease control, but also fairness and equity. And I’m sure there’ll be a fairly big dose of politics in it as well.
SHANOOR SEERVAI: And so on the one hand, we have all these populations who are especially at risk and need the vaccine. But on the other hand, there’s this question of people being hesitant to get the vaccine, people being concerned about some of the safety issues that you laid out. So how do we actually get people to take the vaccine once it is developed and safe and effective?
PEGGY HAMBURG: That is the crux of the issue at the end of the day, because even the world’s most safe and effective vaccine won’t make a difference if people don’t trust it and won’t take it. And we know that already there’s been an antivaccination movement that has put out misinformation about vaccine safety, but it has tragically resulted in underimmunization, especially of kids in certain communities, with the consequent outcome of resurgences and outbreaks of serious preventable diseases like measles. And that antivax movement has been busy on social media during COVID 19.
But in addition, because of this acceleration of the research and development process that people are worried about, because nobody wants issues of, of safety and efficacy to be short-shrifted in favor of speed. People want a vaccine as quickly as possible, but they want one that will work and help keep them safe. The issues around are we going too fast in the context also of this incredible visible political pressure and the President making pronouncements about how he’s going to make sure there’s a vaccine by the time of the election really has added a new level to vaccine hesitancy and concern about these vaccines in particular, and can they be trusted?
SHANOOR SEERVAI: Many polls show that public confidence in a COVID-19 vaccine is low and notably much lower than it was a few months ago. So listeners, I want to ask you, would you take the vaccine once it’s available? Send us your thoughts. Our address is [email protected].
Now back to the show.
SHANOOR SEERVAI: Peggy, we’ve talked about how people of color have been worst hit by the pandemic. What do we know about whether they would trust the vaccine?
PEGGY HAMBURG: The numbers in terms of distrust of the vaccine amongst the African American population are higher than other populations, in part because of past distrust of health care systems and experiences with research and with inequities in care. So we need to make sure that people have trust and confidence in vaccines. We need to make sure that the process is as open and transparent as possible. We need, frankly, to get the politicians out of the way and let the scientists drive the process and to engage the public in their communities with people talking to them about the vaccine that they trust and know. Not necessarily scientists in white coats and certainly not coming out of the Oval Office, but people that they know. Maybe their family physician or someone in their faith community.
SHANOOR SEERVAI: So I feel like what I’m hearing from you is that it’s really important to have a tailored community-based public health approach to get the vaccine out into communities of color, as you say, into rural America, into the cities. And different communities may need a different approach. They might trust different people. It’s not enough to just have a leader at the federal level say, “This is the vaccine, everybody go out and get it.”
PEGGY HAMBURG: I think that’s absolutely right. And it creates more challenges for distributing this vaccine, but it is as important as having a safe and effective vaccine. We really have to make sure that we have a system for distribution that’s transparent and trusted, that we have mechanisms to get out the word about how vaccination is going to unfold, what it’s going to be like and why it matters. We have to engage at many different levels from the community level up through the national level.
And frankly, we also, I think, need as a nation to make a commitment to the global vaccination effort as well. Because truly we will only be safe in this country in a global pandemic if we address the virus and its spread wherever it is in the world. So we have a lot of work to do. We’ve got to develop a vaccine that works and is safe and that’s a big challenge, but equally big a challenge is to really make sure that we have a distribution and tracking system that will work and that people trust the vaccine and the providers enough to actually take the vaccine to create the kind of protection and control of this disease we need.
SHANOOR SEERVAI: I did want to ask you about this global element because at the moment the U.S. borders are pretty much sealed and there’s not a lot of international travel. But this hopefully is going to pick up again in the future. And as you say, we can’t be safe if only Americans have been vaccinated. Ultimately we need to get to the most remote corners of some of the poorest and least developed countries in the world. And how are we going to do that?
PEGGY HAMBURG: Well, that’s right. And I think of course, every country and their leaders are going to want to look out for their own citizens. But at the same time, we do have to recognize that we live in a globalized world, that this virus is going to be with us for a considerable period of time. And that the best way to protect any nation is to also look out for the needs of other nations. And that involves being willing, for the rich nations like the United States, to make a commitment to participate in global vaccine development and allocation efforts.
So far, our country has not indicated a willingness to do that. I hope that will change, but I think for many, many reasons, including our own vested interests of both disease control, as we’ve been talking about, but we also don’t know which countries are going to end up making the most successful and effective and safe vaccines. So it’s in our interest to sort of diversify our portfolio a bit as well. And by really engaging and being part of a collaborative effort with other countries around the world, we can do good for the rest of the world and we can do good for our own nation.
SHANOOR SEERVAI: And as we think about this very complicated process, you’ve sort of laid out the tip of the iceberg for us today. It’s going to take several months to get this vaccine distributed across America and then across the entire world. So what are people supposed to do until then? How do we keep the virus at bay?
PEGGY HAMBURG: Well, I think realistically, we’ll start to get available vaccine probably sometime in the first half of next year. But it’s going to take more than just months to get vaccine to the people who need it in the first set of tiers of priority for vaccination, and then to extend that even further. So we have to recognize the virus is going to be with us for a while. These first vaccines, as we talked about, are not going to be fully protective. So we may still see people even who’ve been vaccinated getting infected, having less severe disease we hope, but if they can get infected, they can still spread disease too most likely.
So we need to recognize that even as vaccine becomes available and more and more people start to get vaccinated, that we will still need to do those fundamental public health measures that we have become so familiar with: social distancing, wearing masks, avoiding large crowds and gatherings, and washing hands. That has to be part of the COVID-19 landscape. We have to continue to take that seriously, recognizing that vaccines will make a huge difference, but they are not a magic wand that when they come into practice, we’ll just erase all of those other important public health measures. We have to have a strategy that has many layers, many protections, and continues to take this virus as the serious and ongoing threat that it is.
SHANOOR SEERVAI: The Dose is hosted by me, Shanoor Seervai. I produce this show along with Joshua Tallman for the Commonwealth Fund. Special thanks to Barry Scholl for editorial support, Jan Wilson and Rose Wong for our art and design, Oona Palumbo for mixing and editing, and Paul Frame for web support. Our theme music is “Arizona Moon” by Blue Dot Sessions, with additional music from Podington Bear. Our website is thedose.show. There you’ll find show notes and other resources. That’s it for The Dose. Thanks for listening.