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Arthur L. Caplan, PhD: Hi. I'm Art Caplan at the Division of Medical Ethics at New York University's Grossman School of Medicine. I'm very pleased to be the host of Medscape's Both Sides Now.
Today we have a very important, timely, and controversial subject to discuss regarding who should get a COVID-19 vaccine first, if and when one is developed and approved for use either in a particular country or by many nations.
Several manufacturers — last time I looked, there were more than 160 efforts underway worldwide — are working on potential vaccines. We do know that even when there is a vaccine for which it's decided by a government or company to start large-scale production, there's still going to be a long time lag before there's a sufficient supply for everyone in the world, the US, or China.
There are many discussions among pharmaceutical companies, medical organizations, and government agencies addressing this distribution question. Many people take it as a given that healthcare workers ought to go first. If we have a vaccine shortage, other people would say older people, especially those in nursing homes or at high risk for death from the disease, ought to be considered early.
Others may say that young people who are part of the workforce and are deemed essential — say, working in the food industry — ought to go first. Others say it ought to be first come, first served and more of a lottery type of an approach either within a country or internationally.
Nations will want this vaccine, many of which are poor and many of whom don't have the resources to purchase and distribute a vaccine. That's just the beginning of the issues involved in trying to figure out how to manage vaccine distribution — again, if we're lucky enough to get one.
Today my guests include Dr Helen Rees. She's the executive director of the Wits Reproductive Health and HIV Institute at the University of Witwatersrand in Johannesburg, South Africa. She also chairs the World Health Organization's (WHO's) Afro Regional Task Force on Immunization. She's also now a member of the Facilitation Committee of the COVID-19 Clinical Research Coalition and chairs the Global Alliance for Vaccines and Immunizations (GAVI), the GAVI Program and Policy Committee, and I believe she is also on the GAVI board.
My next guest is Dr Paul Auwaerter. Paul is the clinical director of the Division of Infectious Diseases at Johns Hopkins University School of Medicine. His areas of expertise include Lyme disease, Epstein-Barr virus, and fevers of unknown origin. He's been very involved with COVID-19 as far as thinking about how to control its spread and potential treatments. He is a past president of the Infectious Diseases Society of America.
Ron Waldman, my last guest, is a professor at George Washington University. He has great expertise in global health and development. He served as a team leader for strategic preparedness in the pandemic, influenza, and other emerging pandemic threats in the US Agency for International Development. He also served as a US government health sector coordinator as part of the Haiti earthquake relief effort.
Each of my guests has tremendous expertise in vaccines and infectious disease, and in thinking about public health challenges. This is a tough issue with many perspectives and many points of view. Hopefully, as we tease this out in this discussion, you'll gain some ways to think through the dimensions of what's involved.
Equitable Distribution of a COVID-19 Vaccine
Caplan: Let me start with you, Helen. We'll dive right into this. There are all kinds of people debating who ought to go first with scarce supply. I keep wondering who is out there, either internationally or nationally, who's going to answer this question. Not just a group or committee or individual who has advice, but who has authority to say who's going to get vaccine and in what order of priority.
Helen Rees, MD, MRCGP: Well, that's a very big question, and perhaps I'll start at one end, which is thinking globally. The WHO has really taken enormous initiative in this field and has pulled in a coalition, which includes CEPI (Coalition for Epidemic Preparedness and Innovation) and GAVI, and they're leading a major global push.
Behind them are many of the big international donors, many bilateral donors. Through that mechanism, there is a global effort to try to say who should get the vaccine first. The backdrop is, of course, that when we first have an effective vaccine — perhaps two next year — probably we're not going to have enough for the whole world. We're going to have limited amounts. We are going to have to say there'll be rationing.
At a global level, the questions will be which countries and how do we get equity between countries? And then the next question will be within countries, who, and who decides that on what basis? What kind of criteria do you apply?
Is it a burden of disease and mortality? Is it disruption to the economy? Is it the most vulnerable in your society? Or is it keeping your health services going? There will be many different conflicting considerations when we think about it.
Caplan: Ron, do you agree that self-interest, even national self-interest, might be enough to drive the equitable distribution of vaccine internationally?
Ronald J. Waldman, MD, MPH: I wish it were the case, but I'm not sure that's what's going to happen. Let's back up a little bit. Helen mentioned one very important element regarding the vaccine, which is that it's not going to be nearly 100% efficacious.
Helen used the word "effectiveness," but there will be a difference between what we hear about effectiveness, or the proportion of people that are protected when the vaccine is given under more or less ideal conditions, and what happens in real life in many of the countries around the world. It's very difficult to even deliver a vaccine and maintain the appropriate conditions for doing so. There's going to be a drop-off.
Caplan: You know, Paul, Ron didn't mention that there's an advisory group on the ground, the task force that I believe Dr [Deborah] Birx runs in our country. They may weigh in. Health and Human Services may have things to say through Secretary Azar in the US.
What's your thinking about distribution within the US in terms of who's in charge, how advice might be heard, and who's listening to it?
Paul G. Auwaerter, MD: From a standpoint of trying to grade or mandate, school-aged children in the United States have obligations for certain vaccines if they're going to enroll in schools, especially, for example, in California, which has passed a state law in that regard. There really hasn't been anything in the adult world since smallpox, where there was a Supreme Court case mandating smallpox immunizations.
I personally feel that there are a number of things that need to be balanced. One is just the current political climate and the fact that I think a number of people are just going to be hesitant to anti-vaccine as feeling like their civil liberties are being infringed.
Caplan: If you don't mind, Paul, let me interrupt there just to ask why they would hesitate? Don't people want a vaccine? We keep being told in the US that we're going to vaccinate our way out of this plague. Is it the usual anti-vaccine resistance?
Auwaerter: I think it's people who are afraid that there are links to a number of diseases that have not been proven, such as autism for their children, ALS, or Alzheimer's disease. Also, it may be the fear of the unknown because this vaccine will be relatively untested and administered in an advanced way.
I do think we have to be very cautious about what kind of recommendations are out there and mandating something. On the other hand, I'm optimistic that even partial immunity in a population may make some significant inroads. For measles virus, we often talk about 85%-90% given how contagious it is. Most modelers are using 60%-70% for this novel coronavirus, but probably even lower levels will be helpful. Obviously, it's how much true protection there is vs just moderation of disease and severity.
Is Global Equity Possible?
Caplan: Helen, I was going to push you a little bit on the international distribution question. Let's say countries say, "We want to have a chance to get a vaccine stockpile." Shouldn't we try to address hotspots or places where there appear to be raging epidemics? I'll say Brazil, the southern United States, or Iran, perhaps, as examples.
Does it make any sense to be egalitarian and say that every country gets a certain percentage of the available supply initially?
Rees: Well, that's certainly one thing that's being discussed. As you mentioned initially, everyone's first reaction is if you have limited vaccine, we give it to frontline healthcare workers because we want to protect them and we want to protect health services. If they're there and they're well, they're able to also protect people who have COVID and all the other illnesses.
Now, having said that, one of the problems in terms of global equity is that there are many more healthcare workers in the developed world than there are in the developing world. You lose equity immediately.
The other point that's being discussed is perhaps if we have very limited vaccine, we can say that we'll give it to the whole world for 3% of your population and you, as a country, decide. If you are a country that really does have hotspots and doesn't have a generalized raging epidemic at that point, you might well decide to focus on hotspots.
If you're a country that has a very vulnerable healthcare worker population, limited numbers, limited PPE [personal protective equipment] access, and limited ability to use it consistently, you might well say that is the priority. If you're a rich European country, your priority may be the over-60s because that's where you saw mortality in your region.
That is another debate, to say that we have an equal distribution of limited numbers in the first place and we let countries decide.
Putting Healthcare Workers First
Caplan: Ron, Helen has said this a few times and it's said in many sectors where these things are being debated and discussed. We kind of agree on healthcare workers first.
I'm going to ask you a basic question: What is a healthcare worker? When I look at the US hospital system, we have people who make food, provide security, transport patients, maintain buildings, do the laundry, and there are administrators.
If I started totaling up who is a healthcare worker, I could use up the entire supply in a couple of big hospitals. And I'm being hyperbolic, but you know what I mean?
Waldman: Right, Art. Even within the group of healthcare workers, there needs to be triage as well. I think we would all agree, probably, that it's really those healthcare workers who are at greatest risk of contracting illness. Those are the people who are caring for patients on the front line of healthcare delivery, I would say, not necessarily those who are in a more supportive role. Although I'm certainly not saying that they're not important, because obviously they are.
Because there has to be rationing within each and every prioritized group, I think one would want to start, if one agrees that healthcare workers should be prioritized, with those who are coming face to face with people who have the potential to transmit the virus and are therefore putting those healthcare workers at greatest risk.
One thing we haven't said yet in regard to the characteristics of the vaccine is that I think we have to distinguish between a vaccine that prevents illness from occurring and a vaccine that will have the ability to prevent transmission. I think that, depending on what the vaccine can do, that might influence where we start.
It would be a reasonable perspective just to say from the start that a high priority for use of the vaccine would be to stop the dying. I think that would point us toward healthcare workers who provide care and toward those population groups that have the highest risk for mortality.
Politics vs Priority in Vaccine Distribution
Caplan: Paul, if we followed the suggestion that we can perhaps identify who's at greatest risk for death, there are some in the US — and I'm sure it's elsewhere true — who are at high risk for death and may not be the most politically popular. I'm thinking prisoners because there are big outbreaks in prisons.
As a politician, can you go out and say, "Before we vaccinate your child, we're going to do prisons. Before we vaccinate your child, I think we're taking this out to Native American reservations that are poor. Actually, before we vaccinate your child or your healthcare worker, I'm headed into poor neighborhoods in New York or Johannesburg or wherever, because that's where the deaths are; it's related to health status and access to healthcare."
Is it doable? Forget about the morals. I'm just asking politically.
Auwaerter: I'm a nonpolitician. As an infectious disease physician, I like to try to be as equitable and as meritorious as possible. I think you identified many of the groups. People who work in meat-packing plants, for example...
Caplan: I can't resist intervening — many of whom may not be legal residents.
Auwaerter: Correct. You look at some of the facilities on our southern border of the United States as well. Latinx populations seem to have very high rates along with other communities.
The burden of disease is one that I would think of, along with trying to balance — as Ron and Helen mentioned — mortality risks. I also think the epidemic might be shifting a bit. We are seeing younger and younger people, at least in the US and also in Europe and other countries, carrying the virus.
As people may be less at risk who are older and perhaps more cautious in taking maneuvers, one question is regarding the maybe less responsible class or the class that's harder to control, including adolescents, which some studies from South Korea have suggested, for example, have the highest rates of transmission. Adolescents visiting their grandparents may be more of an issue. Additionally, we have to keep schools and universities open, and protect teachers and facilities.
I'm going to have to balance how I think about things once we know the characteristics of the vaccine and how we might target it. Many people are familiar with the pneumococcal story — granted, it's a bacterial vaccine. For older people, in terms of avoiding pneumococcal pneumonia, there's not as much benefit from immunization as opposed to what seems to have been rolling this out among children.
Balancing Other Vaccination Needs
Caplan: Helen, I seem to come back to you with the tougher questions about international allocation. I know you've been around these questions for a long time and I think you're well positioned to answer this question, which is COVID vaccine efforts, scarce vaccines, thinking about who goes first, and then trying to up the supply.
What about the vaccine efforts for other diseases? It may not be the biggest problem in country X; it may be deaths from rotavirus in infants, HPV, finishing polio, or measles. Are people thinking about balancing or shifting the entire world's vaccine effort over to COVID — which some mornings that's what I think is going on — against trying to balance the impact on other killers around the world?
Rees: I'll answer that in a couple of ways. First of all, there's the absolute disruption that COVID is causing to health services, both in people wanting and feeling confident to attend health services. Second, in the delivery of health services, and we're talking about vaccines — actually the supply chain of vaccines — all of that has been profoundly disrupted.
As long as COVID is going through in waves and we've got lockdowns and lockups, we are going to see continued disruption. The modeling suggests that the disruption in many parts of the world, but particularly in the poorer countries from disrupting immunization services, is going to cause many more deaths than we are going to lose people from COVID.
The problem is that we can't fix that if we don't in parallel fix COVID because that disruption is going to keep coming in waves. We've seen not only immunization deaths increasing, but there are articles out today about HIV deaths increasing and tuberculosis (TB) deaths increasing extraordinarily because TB testing has stopped and access to drugs has stopped.
In terms of your question, immunization services are going to be disrupted unless we can get COVID under control. That's one thing. I think you're also asking, are we going to divert all of the global manufacturing resources, for example, and the research resources? Is everything going to be completely diverted now toward COVID?
It's an important question because we have limited manufacturing capacity. There are several things to consider. One is that some of the much bigger facilities and manufacturers have said that they are going to be able to maintain other routine vaccine production. The second thing is, if there is some good to be seen as a sort of spinoff, there has been a massive investment in manufacturing spaces.
Billions and billions of dollars have been put in from various sources, both national and global, into establishing rapidly manufacturing sites, often from established manufacturers, but changing and upscaling to actually increase manufacturing capacity now. We are going to have increased manufacturing and we have some limited guarantees that other vaccine supplies won't be impacted.
Going With the First Vaccine or Waiting for Better Outcomes
Caplan: I'm worried that we'll be so eager in whatever country when the WHO or GAVI will say we have a vaccine that's 40% effective and requires two shots, that we're going to roll it out. Then, 3 months later, someone is going to say, "I have a vaccine with 65% efficacy in one shot," but we've just devoted big amounts of production capability and distribution and training and whatever to the first one out of the box. Does that concern you?
Rees: I'll have a first stab at that. The production capacity for all of the vaccines that are in the more advanced stages of development is already being established. It's not going to be that we get to the end, we have an effective vaccine at whatever level, and then we think about production.
That production capacity is being committed now, as we speak, and over the next few months. It's not going to be that the first one out of the box is going to get all the production capacity because we're seeing that that planning is already happening for a host of vaccines that are in development.
Waldman: I'd like to back up and just make sure that I mention a few of the population groups that we haven't talked about yet. I've spent most of my career in humanitarian assistance, and I'm thinking about who's going to be looking out for refugees, for displaced people, and for people who are living in areas where there's ongoing armed conflict.
There are many parts of the world where people simply do not have adequate access to any health services that are potentially available to them. Of course, we're adding this new one in a COVID-19 vaccine, but regardless of the production capacity, and for these population groups that we're mentioning, everything that they need exists but they just don't get it.
I'm worried a little bit about them in terms of equity. I'm also worried about the many countries where, regardless of vaccine production capacity, the vaccine delivery infrastructure in those countries is not up to snuff. It remains less than perfectly adequate.
Caplan: Ron, do you mean roads, refrigerators, and people to deliver it?
Waldman: Absolutely. I'm thinking that a vaccine can get to a capital city, but then it's another matter to get it out and into the arms, if it's an injectable vaccine, of the people who need it and who are living in more far-flung regions or areas of the country.
We've had perfectly adequate polio vaccines for a long time, but we have not been able to finish the polio eradication. We have everything we need to do it. It's the circumstances in which people live that prevent us from achieving that goal.
Rolling Out a Vaccine: Move Quickly or Move More Carefully?
Caplan: I'm going to ask you two more questions. Here comes a vaccine. Everybody's excited in the US and our president is basically beside himself.
They say, "We have a 30,000-person randomized trial running. We're at 15,000 and it's looking good. The election is in November and we are now to October. I think we ought to get this thing approved and start to roll it out on an emergency or compassionate basis. It isn't really the full study, but those healthcare workers we've been talking about are still at risk. Those nursing home residents we're all concerned about are still at risk."
I'm doing this in the US, but it could happen elsewhere. Would any of you favor the early rollout on an emergency basis without completing the standardized trial in order to try to get benefit more quickly, putting aside the politics? Paul?
Auwaerter: I've been a member of a data safety monitoring board, and I think it depends on how the information looks at the time. It's possible that if you're at the 50% mark, that the data do look rather compelling. This is a tricky respiratory virus with immunologic potentials, and many are worried, perhaps, about things that we don't have great signals for, such as antibody-dependent enhancement, which could mean worse disease if you're actually exposed to the novel coronavirus after immunization.
Again, we have to be cautious. I think many of us worry about a political mandate. I'm also afraid that if things go poorly, we poison the public health well tremendously for many other vaccines, and that makes for a worse problem. I'm hoping that decisions will be made in a very prudent way and not one that involves shortcuts.
As far as I know, at the moment, there is one vaccine already with limited approval, and that's in China, which is currently administering the vaccine within its military forces. Obviously, some have already taken that step. My feeling about this is that populations would be voluntary. Steps should be taken with some caution, trying to help balance many of the issues that have been discussed already today.
Should COVID-19 Vaccination Be Mandated?
Caplan: At the risk of opening up yet another can of worms, I'm going to end by giving each of you the opportunity, within your own country and purview, to say whether you can conceive of situations where we would be at the other end of distribution and mandate a vaccine.
We do have school mandates in the US. Other countries have them for some vaccines for some kids. We know that there are exemptions, waivers, and that many people don't want to follow the school mandates. Mandating adults to get vaccinated, I think, is a separate, interesting enterprise. I'm just interested — forget about the practicality.
Helen, what do you think? Could you ever imagine if we had some nirvana, utopian scenario with a large amount of vaccine, that "we don't care if you don't want to take it; you have to take it both to protect yourself and control spread."
Rees: I think, as you mentioned, it's going to be country specific. It's going to depend on the democratic or other structure and function of the country you're in as to whether that is going to be acceptable or unacceptable.
The one group where I think that we have seen very strong recommendations and strict mandates globally is in healthcare workers, and that's both to protect them and to prevent transmission to other patients who are not COVID patients. And then, of course, children.
This, as we know, is not a disease that really causes serious illness, and that might be a much more difficult arena. There might be other emergency workers where you feel that it is essential, including emergency or other frontline workers or essential workers in terms of maintaining social order. Again, in certain countries, you might see that.
In truth, it's also going to depend, at the time that we get a vaccine, on how good our treatment is. Have we lowered mortality rates? Are we getting better and better at treating people in hospitals and treating milder disease? If we've lowered the severity of the disease, the benefit/risk of trying to force things on people might then swing in another direction.
I would say that if you are going to think about that, then in a South African setting, it would probably be something like an opt-out that we would want — for example, all healthcare workers have the vaccine unless there is a motivation on a health ground or on a belief ground that they should not have it. An opt-out might be one way to get around absolute enforcement.
Caplan: Ron, do you have any enthusiasm for the vaccine police?
Waldman: Not great enthusiasm. I am speaking from Sweden today. Even here, there is considerable opposition to mandates along the lines of what we're seeing in the US regarding people's perception of their freedoms being restricted.
I think that sometimes it does have to be done. Paul mentioned the mandated smallpox vaccinations. The WHO does mandate on the yellow card that we travel around the world with vaccination for yellow fever and used to do the same for cholera vaccination. It's not unprecedented.
I think that it would be much more preferable to have people offered an intervention to have it explained to them why it's being recommended, and to try to convince people using softer power rather than police power, as you put it.
Caplan: Paul, you get the last word on this. Any enthusiasm for using clubs rather than carrots?
Auwaerter: Even with the many economic mandates that are in front of us, it's very difficult, given the uncertainties with this virus, to provide a mandate. I think it opens up many questions.
I do think there's enough sense in the United States that approximately 70% of adults would take up the vaccine. Longer term, I do see where this will be a requirement for children even if they're not at risk, university students, and perhaps for entry into nursing homes if the vaccine's effective. There will be ways to roll this out over time.
I just think a mandate, especially when we don't have an ability to go toward eradication — which was, of course, the smallpox model — just doesn't make as much sense because I don't think we're going to get to eradication. We're going to get to control.
As Helen mentioned, perhaps we'll have better antivirals. Perhaps we'll really have great impact with plasma or monoclonal antibody cocktails to really help control this far better than influenza, and then it becomes a similar risk. It's still not wonderful because 40,000-60,000 people might die, for example, in the United States, of influenza.
I think it will take a year or two at a minimum to get to that. Also, as you might imagine, even though we're talking about vaccine rollout, if it's two boosters, you're adding months. You're waiting for vaccine response. Everyone's thinking that by New Year's 2021, we'll all be free. It's really going to be far further, I believe, into 2021 if we have a successful vaccine, just given the logistics.
Waldman: I agree with that entirely and with what Helen said as well. As a public health person, I have to say that the improved treatments would be wonderful, but it has to be said that a vaccine will be a fantastic tool, but it's an additive one. We do have tools that we know of that have efficacy, including face covering, distancing, and handwashing. These are all things that work.
A vaccine certainly would be welcome and may be seen as more easily delivered and less threatening to some than others. I think that we can do a quite substantial job of controlling the pandemic with the tools we have available now, while desperately hoping for an additional tool to come along. We've discussed, depending on its potential level of efficacy, that it might be a great tool. It might for a while be a useful tool, but it certainly will not be the be-all-and-end-all of what we need to bring the pandemic to a close.
Auwaerter: Ron, I'm the biggest vaccine advocate, as many people are, but you're quite an optimist with human behavior. So far, I just don't see where that kind of traction will really be durable in so many parts of the US and even elsewhere in the world.
I do think the vaccine is going to be what we need because all the behavioral aspects are fine for you or me or people who have the will to follow them, but many don't or can't, to be honest.
Waldman: I'm just concerned that we're living in a different age now from when I began my career in the smallpox eradication program, when getting vaccination uptake was not really an issue. If you offered it, people got it. You mentioned before that one of the problems with a vaccine mandate would be poisoning the well of public health and for use of other vaccines.
I'm sitting here in southern Sweden now, where there are really very few cases occurring countrywide, with one daily admission to an ICU at this point in time. Of course, it will come back and it will occur in waves. I think there are ways to get this done.
Maybe Sweden is not the best example because it doesn't have a very good reputation. They've made their mistakes, but they also have a population that they like to consider is more adult than what exists in many other countries.
By the way, if I can just add on, I saw a poll the other day that, even among healthcare workers, there is substantial resistance to accepting the vaccine. A little bit more so in nurses than physicians, but the average was up there — close to 50%.
Caplan: I was going to jump in and say by way of wrapping up that I do not think that vaccines will be the magic bullet, but certainly, having them would help add to the firepower needed. I know that I've learned a lot from listening to this discussion about things to think about with respect to national vs international distribution.
I'm certainly well aware that we have much to think about in deciding who goes first with respect to getting a scarcer supply of vaccine.
I really hope that this excellent discussion can help shape both policymaking and your thinking about who should get the vaccines when we get them, as the debate evolves around who's going to be first to receive a vaccine, both in the US and outside the US.
I want to thank my panelists; they did an outstanding job. I want to thank you for watching Both Sides Now.
Arthur L. Caplan, PhD, is director of the Division of Medical Ethics at New York University Langone Medical Center and School of Medicine. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues.
Paul G. Auwaerter, MD, is a professor of medicine at Johns Hopkins University School of Medicine and the clinical director at the Johns Hopkins Hospital Division of Infectious Diseases, both in Baltimore, Maryland.
Helen Rees, MRCGP, is a professor at the Wits Reproductive Health and HIV Institute, Wits University, Johannesburg, South Africa.
Ronald J. Waldman, MD, MPH, is a professor at the Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC.
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Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Arthur L. Caplan, Paul G. Auwaerter, Ronald J. Waldman, et. al. COVID-19 Vaccine: Which Country Should Get It First? - Medscape - Aug 27, 2020.