Vaccine Ethics: What Are We Learning from COVID-19?

JOEL ROSENTHAL: Good afternoon. Welcome to our webinar on "Vaccine Ethics: What Are We Learning from COVID-19?"

I'm Joel Rosenthal, president of Carnegie Council for Ethics in International Affairs, and we are delighted to be partnering on this program with the Berman Institute of Bioethics at Johns Hopkins University. Carnegie Council and the Berman Institute share values, goals, and a common mission. We are both research-driven organizations seeking to generate ethical solutions to global problems. We also place great emphasis on multidisciplinary expertise and the relationships we have built with scholars, leaders, and innovators around the world.

I would like to begin with a special thank-you to Ruth Faden, the inaugural director of the Berman Institute, and Jeffrey Kahn, the current director. I admire both of you very much. As the founder of the Berman Institute, Ruth has shown us the way to do what we do, to ask the hard questions, to explore shared interests, and to develop actionable principles to serve the common good. As her successor, Jeff Kahn has brought to bear his own leading scholarship in bioethics and health policy. He is expanding the institute's reach nationally and globally to meet the demands of new issues in biomedical technology.

I would also like to introduce our accomplished panelists and thank them for lending us their time and their expertise.

Reed Tuckson brings to us years of experience in health policy. He has served as a commissioner of public health and in senior executive positions in academic medicine, non-profit advocacy, and health systems management.

Clive Meanwell is executive chair and founder of Population Health Partners, a global investment firm. He previously founded The Medicines Company, where he was a leader in drug development and healthcare innovation.

Nicole Hassoun is a professor in the Department of Philosophy at Binghamton University. She is also co-director of the Institute for Justice and Well-Being, project head at Global Health Impact Project, and was recently a visiting scholar at Cornell University.

We put in front of this panel an incredibly ambitious agenda, and they have all answered the call. I thank you again for doing this. Given this very big agenda and the constraints of time, I am going to hand this over directly to Jeff Kahn, who will chair this session.

Over to you, Jeff.

JEFFREY KAHN: Thank you, Joel. Back to you in terms of thank you for your partnership and willingness to co-sponsor this with us, and thank you for the nice shout-out.

Thank you to my co-panelists for joining as well. I look forward to a really interesting and engaging conversation.

Let me do just a tiny bit of setting up, and then we will get right into our conversation. The way we decided to do this was not through a serious of presentations but rather engaging in a discussion among the panelists from the outset. We have broken our time down into three topical areas by agreement.

The first will be about vaccine manufacture or production, the process through which we have witnessed the science and the clinical trials and hopefully soon the approval of a new COVID-19 vaccine or a few.

The second topic we will take on relates to public trust, willingness to accept vaccination, vaccine hesitancy, and how that might play out both among communities and then globally and the impacts of that in terms of public health and ethics.

The third topic we thought we would take on relates to global distribution and allocation, realizing that there are 7 billion people on the planet and that we need to think about how to manage what is a colossal undertaking in terms of vaccinating the vast majority of those people if we want to achieve the public health goal of beating this pandemic.

We hope to do about 15 minutes on each of those topics and then leave a good healthy half-hour for discussion from those who are watching. I know the idea is for you to all add your questions and comments in the Chat. We will have someone behind the scenes doing some filtering and collecting those so that when we get to the discussion portion of our time together they will be collected in a way that we can curate them a bit, and we will engage with our panelists for the last half-hour around that.

The last thing I will say before I launch in is that in our pre-discussions about these three topics we realized that there were three different elements that we thought were important to address. One is describing what is going on, so a description aspect; the second is a diagnosis, what to do about the things that we identify in the course of our discussion about these three topics; and then the third piece, prescription: What to do about the diagnoses. I don't know that we will be slavish to that formula, but that is the way that we had thought about articulating the issues and how to address them.

With that, let's get underway. The first topic relates to the development of the vaccine and its subsequent—hopefully—approval and availability.

I will start with you, Reed, to take this on first, but I know this will be something that everybody wants to talk about.

Obviously the vaccines that have come through the process so far have done so in a timeframe that is unprecedented for the development of vaccines for human use. How could that have happened is one thing to say. There is a descriptive part: Why has it been six months or nine months, whatever it has been, for these vaccines, when it usually takes five years at a minimum for other vaccines?

This will I think help inform our second topic: What should people be thinking about the fact that we were able to make it through a process and did all the basic science, the clinical research, hopefully through the regulatory process, and get something available for distribution so quickly? What should people take away from that in terms of the process by which we typically do this set of things and have done it this time? Obviously it will inform what people will think about their willingness to accept vaccinations.

I have hopefully given you enough time to get your thoughts together. Let's start with Reed, and then we will add others.

REED TUCKSON: The most important thing to realize is that the development of the vaccine here did not begin with the first day of the pandemic. This is part of a process that has been going on. There were an awful lot of lessons that were learned from the Ebola experience, where we were not prepared, back in 2016. As a result, scientists from around the world—and this is a very important point that we will be coming back to later—were collaborating together and planning on how to make a more rapid response. So they were very fortunate that in their planning scientists specifically asked themselves: "How can we be ready?"

What they then did was to be able to take a common cold virus that had infected chimpanzees, and they engineered it to be basically a building block against almost anything. They had this shell that they could then quickly modify. That was very important.

The next part that was important here was that right at the first of the year, when the first hints out of China were coming that there was a virus that was responsible for significant spread to people, that got everybody targeted in, and they got involved. The good news actually was that this was a coronavirus that was doing it. That is something that scientists had great experience with, so they were able to take that information and then be able to use that with their shell that they had built, and they understood that they had to fight against this spike protein that was a clear target for them. That is in fact what happened.

All of that process was very, very rapid because we had preexisting planning for this moment. We had a preexisting engineering engine in terms of the vaccine that they had started to create, and then they were able to modify that with a coronavirus which they were very attentive to and knew something about.

Last, they were able to do this because as you know we have been able to run our clinical trials in simultaneous levels of clinical trial status as stages I, II, and III, not neglecting them but running them in parallel as opposed to in sequence.

The final point is that there was a lot of money that was available in the system, so the economic engine drove it as well. That is why we have been able to move so fast. It is important to remember that it was not because we started with a standing start among the first cases reported.

JEFFREY KAHN: Great. Thanks, Reed, for that.

I want to maybe ask Ruth next, and then we will come to Nicole and back to Clive.

Given what Reed just said about the process and how we got there, which seemed like in a rapid manner, all this in the context of a very built up process by which we do regulation, oversight, and protection of human subjects in research, it doesn't feel like typical status quo in terms of how this all unfolded, which I think has led to people feeling like: I don't know whether we have done this in the right way when we have been told all these years before that it takes a long time, and we do this very carefully, and here are all the good reasons why.

Maybe you can say something about the regulatory, oversight, and human subject aspects of this, all put in the context of Reed's nice framing.

RUTH FADEN: Happy to.

What I would like to do for a second, Jeff, is just underscore something that Reed said that I think is very important and will resonate when we get to the global conversation later, and that is that the work that Reed was referencing was done after Ebola. There was this wake-up call: "Why did we screw up so badly in response to Ebola? Why did it take so long?" There was an international effort that was convened and put together, a coalition called the Coalition for Epidemic Preparedness Innovations (CEPI), which was an organization that was set up from nothing with the intent of jumpstarting so we would not be in this position again.

One of the tenets of CEPI is global equitable access to vaccine. That is one of its claimed commitments. We will circle back to that later, but a lot of money was poured into this Coalition for Epidemic Preparedness Innovations initiative as Reed was describing, and as part of that process they took the World Health Organization (WHO) list of low-probability but high-consequence threats of emerging and new emerging infectious diseases.

As Reed was pointing out, they conveniently picked severe acute respiratory syndrome-related (SARS), coronavirus-related threats as a high-priority threat to invest in. Similar things were going on at the National Institutes of Health (NIH), so Reed has captured it perfectly, but it will be later when we talk about this combination and the conversation goes global we have to go back and think about the roots of investment were not only national but global from the beginning with a lot of money from two big foundations, two big philanthropies, one from the United States and one from the United Kingdom.

In terms of the regulatory oversight and the human subjects issues, everybody worked faster than normal, including the institutional review boards (IRBs) and the ethics review boards. This is not to say that they were cursory, but my understanding is that these trials went to the top of the line for research ethics committees globally, and that cut through. For any one of us who has ever been an investigator and knows what it takes, sometimes you are just waiting for your turn in the queue. This all went to the top of the queue.

In the United States existing clinical trials networks that Reed knows so well that were set up for HIV/AIDS were adapted and shifted over, and these investigators and their research ethics committees know well how to work together. I think that helped enormously in terms of saving time but not reducing the stringency of the oversight.

Again, I think no one could claim to know what went on in every site, in every research ethics committee, that was engaged in looking at the clinical trials, but I do not have an impression that there were shortcuts from the standpoint of regulatory oversight of the sort that we expect from high-functioning ethics regulatory mechanisms.

JEFFREY KAHN: Maybe the way to capture what you, Ruth, and Reed have said is that there is a new paradigm emerging. We did this in a way that was faster and more efficient. We marshaled resources in a way that had been unprecedented for obvious and good reasons.

Maybe to you, Nicole, if that's right—and maybe you can opine about whether you think that's right—what are the implications for how we should be thinking about global health policy, not just for this pandemic and vaccines but in other, broader contexts too?

NICOLE HASSOUN: We have seen some amazing things I think globally in terms of getting vaccines developed and approved quickly, but I am not convinced that as the coronavirus surges around the world for the first time people who are in developed countries understand what it is like to lack access to a vaccine or other treatments that they really need. That has been a reality for a long time in poor countries.

Fundamentally we have a patent system, a system for rewarding pharmaceutical companies for research and development, that rewards them for focusing on the things that usually they can make the most money developing. That will be treatments often that don't cure but treat chronic diseases of rich patients. Those incentives are fundamentally unchanged, so I think, yes, if we have another global pandemic and a lot of rich people's lives are at stake, then we will see the kind of response that we have seen.

The more fundamental problems of lack of access to medicines and to prepare for pandemics to address them even more quickly, I think it would be nice to see even more movement in terms of changing their research-and-development systems so we can reward companies based on the health impacts of the technologies that they develop, so that we focus on saving the most lives and alleviating the most disability.

We have this global initiative called COVID‑19 Vaccines Global Access (COVAX), which helps speed up the development—along with other countries' investments and so forth—of the vaccine. It does it though these advanced purchase commitments, the same kinds of things that countries are using to engage with pharmaceutical companies. But we can use that kind of proposal to, say, create incentives for companies to focus on pandemic preparedness more broadly, focus on addressing some of the world's worst health threats, by rewarding companies based on the health impacts of their technologies and not just the profits that they can make by selling to rich consumers.

I think that is both a prudentially wise thing for us to do in order to be prepared for these other pandemics and in order to address the ones that threaten to resurge as we get antibiotic resistance and so forth, but also morally the right thing to do. I can talk a little bit more about how to do that in the details, but that is what I have been thinking about.

JEFFREY KAHN: Maybe we will come back to that. When we talk about global distribution we can get into some more of the details.

I want to come back to you all, so I am going to say something that I want you to be thinking about and the implications in the way you have all answered the question so far of what has happened with the Chinese vaccine and their implementation to the extent that we understand it and also what is happening with the Russian vaccine.

Clive, before I do that, I want to ask you about the resource investment piece of this, given your expertise. Before you came on Reed was articulating the reasons the world was able to make it through what is usually quite a long process so quickly, and one of the answers was lots of resources invested. But those were not all invested from across a widespread set of pots of money. Some countries spent a lot of money, and other countries are waiting to see what happens in terms of access to the things that were produced from those investments. Maybe you can say a little bit about how investment in these areas works and their warping or equitable access creation in terms of what we are going to see next in the vaccine pipeline.

CLIVE MEANWELL: Thank you.

First of all, I think we have to look to our leadership, our policymakers and executive leaders, who really set the tone for this. When you learn as an entrepreneurial group, for example, that anything that can't bring data by the 3rd of November is not going to be funded, that is a rather perplexing way for the whole thing to be run, because science does not follow those kinds of timetables, even though this particular science got pretty darned close in impressive ways.

I think it has to start with the right signaling to industries and their entrepreneurial groups and funders that the stakes are high enough to play in and that those stakes can be equitably played for because I think several companies that I am aware of have probably superior technology, not necessarily the vaccines, which are excellent, but for other parts in therapeutics and biologics, antivirals and even monoclonals, for example, which will probably be superior to the first generation, which we rushed to. There is nothing wrong with that, but by saying that the only top-down funding will come for things that can happen in a period of time I think is literally short-sighted.

I think we now need to make sure that the momentum of top-down funding from governments to entrepreneurs continues because in my opinion scientifically the best is yet to come. That is an interesting problem to solve because picking up the momentum again when we have had such marvelous news on some vaccines is going to be challenging.

The second thing is that already I think there are technologies which have been lined up by entrepreneurs and industry groups for pandemic preparedness, which again have been largely ignored, but it is worth remembering that tomorrow, SARS coronavirus 3 could start. I feel that the rush to November may have impeded some good science. That is one thing to say. I think the tone is very much set. I am not sure this is a political statement because whoever was making those remarks was probably on their knees to crawl in the best of times, but I think tying scientific solutions to a specific date is never the wisest thing because you never know what is coming along. Science is a somewhat magical process to many people, and timing it is even difficult for those who do it, so I would say that.

Is there going to be more demand for top-down money from governments and non-governmental organizations? Yes. If they are able to sustain their enthusiasm, the worry signs I think are of some dwindling enthusiasm in the last six weeks for anything other than buying vaccines. I think that is probably a medium to long-term error.

I am not sure. I think everyone is a bit exhausted, both literally and metaphorically. A lot of checks have been written, and we will have to regroup. I hope that the new American administration can regroup quickly and set priorities again, maybe with a slightly long-term view. I believe G7 will make a real effort next year with the British leadership trying to establish priorities for the medium to long term in a more systematic way. I heard the comments earlier about pandemic preparedness, but that will require billions of dollars too.

I don't know. I think with the vaccine news a lot of people have taken a sigh of relief and even a slightly premature victory lap, but we will have to regroup quickly and come back to top-down funding but hopefully with a very strategic view this time on a global framework. Again, we did not see the best global leadership in the last 12 months in my opinion, and the industry will be opportunistic and will react to what that leadership does. It is as simple as that. Even if you have to go to the World Economic Forum group, which is how CEPI got started, the industry will follow the money if the money is there, so that money should be strategically distributed, and I am not sure it has been.

JEFFREY KAHN: Great.

Clive started to do what I was going to ask you all to do, so we will come around. The Chinese and Russian examples I think are helpful for the prescriptive: What are we taking away from what we have learned about the process? What can we do better? Clive just answered that from his perspective. World leadership was not what it ought to have been or could have been or should have been in the context of the development of a vaccine.

What would you all say if I were to ask you: What is the takeaway here in a prescriptive way for what we might have done better and need to do better next time? The Chinese and Russian cases can be examples from which to build.

Let's start with Nicole.

NICOLE HASSOUN: I think there are some criticisms particular to the Chinese and Russian vaccines. Global health officials express skepticism and mistrust of vaccines that are approved quickly or distributed quickly, so it is important to engage in the full clinical trial testing process to ensure safety and efficacy of vaccines. We have expedited that, but as you saw in the AstraZeneca trial and in some other previous vaccine trials, like with dengue, vaccines have adverse reactions in late stages, so we do need to have that kind of testing and so forth in place.

To return to the point I was trying to make earlier, I think that this is an opportune moment for us to think: How do we want to reward research and development globally? What are the good things to get companies and entrepreneurs and so forth interested in pursuing, and how can we ensure that we get early access to other vaccines for pressing health problems—HIV, tuberculosis—that are still plaguing the world's populations, as well as those that threaten and will probably continue to threaten us in future pandemics? We want to make sure that everyone has the development of medicines that they need to address the worst health problems globally.

JEFFREY KAHN: Great. Ruth next, and then Reed, and then we are going to go to our next topic.

RUTH FADEN: Thank you, Jeff.

I am going to speak specifically right now because you asked about the Russian and Chinese vaccines and go back to the global ethics challenges with respect to equitable access, not just for vaccines, but as Nicole rightly keeps reminding us for much more that is needed to keep people at a point where they can have a decent human life in terms of their health.

We have two countries that have invested heavily in the development of vaccines. The Russian vaccine, from a company called Gamaleya, I think now is called Sputnik V. I have to say that every time I say that I feel like I want to say the Soviet Union is developing this vaccine, but okay, it is the Russian vaccine.

It is a vaccine, the data about which has not been much reviewed outside of the Russian scientific network that said that the Russian government is actively shopping their vaccine to a range of middle-income countries right now, some of whom may already have signed bilateral agreements we think, but they are not yet publicly known, at least as far as some of us who are watching this space can tell. The Russians have approached the WHO for potential review of their vaccine data. We will wait and see what happens.

The point is, when we try to estimate something like the size of the numbers of people for whom courses of vaccine will be available, until we know exactly how many doses the Russians are saying they can produce for the rest of the world as well as for their own country, and something about how good their vaccine is, that is going to be a big unknown.

The Chinese have multiple vaccines in development. Actually both the Russian and Chinese vaccines are deployed widely in both of their countries. The Chinese vaccines, one of which is developed in conjunction with a Chinese-Canadian company, and that particular vaccine has seen the most public scrutiny because it is a Canada-China joint venture. They are working out and making major commitments with countries around the world, and this is clearly—I am thinking especially for international relations, foreign relations participants and audience members—an exercise in soft diplomacy at a massive scale. The United States—as a non-foreign relations person, I look at it from the outside—is losing an extraordinary opportunity here, and the Chinese and Russians are filling this gap.

Whether the Chinese vaccines are of the quality we would like, we will not know until we see the data, but I am going to hazard a guess that there is a decent chance that they are pretty high quality vaccines. They short-cutted in both cases the process that is being followed in the United States, Europe, Japan, India, and many other countries. If we are worried in the United States—and we will get to this—about whether a vaccine that is developed in a short timeframe is something that we as individuals should take—and I personally am not, but that is what we are going to talk about next. Certainly I have talked to colleagues and journalists from countries that are anticipating making available Chinese and especially Russian vaccines, and they are deeply worried about the confidence that the publics there should have in these vaccines, because there the process has been super-short-cutted and way less transparent.

JEFFREY KAHN: We are going to talk about trust in a second, but I want to give Reed the last word on this topic before we make that switch.

REED TUCKSON: In the interests of time, let me just say that Ruth nailed it. I want to underscore two key points:

One, I think it is very important to understand the geopolitical issues here and the dangers that are there, not only the dangers of the United States having ceded a leadership role around the world, which has its own implications, but I think also the sense that by combining political objectives with scientific interventions you start now to run into a whole serious of ethical minefields.

Second, what is really key that she also mentioned—and it is where we are headed now, so I will just touch it—is that there is a real sense that as these vaccines that have not received the kind of testing certification that we would have expected here in the United States, there is the presumption by many parties that people in poorer countries are being used as guinea pigs and that this is a way in which people will find out how well vaccines work or their safety in people who are dependent upon the largesse of these donor countries. That sets up a whole set of anxieties in a world where everyone is interconnected and there are no secrets to what is going on. What happens in Mali is known all around the world.

JEFFREY KAHN: Great. Perfect segue to the second part of our conversation. Thank you for that. Thank you all for the interesting answers to our first set of questions.

We are going to talk now about trust and public confidence and willingness to be vaccinated. I should say too, you all talked about the Chinese and Russian vaccines. We should also note that the UK medicines regulator approved yesterday on an emergency-use basis the Pfizer vaccine. So it is happening quickly.

In all of that context that you have already articulated we have to figure out how to allocate what we have, but we also have to figure out how to get people who we say should be prioritized for the allocation to be willing to be vaccinated. Just before we came on the webinar there was a news piece I saw go across my email that Presidents Obama, Bush, and Clinton all have said that they will be vaccinated live on television at the same time in order to instill public confidence. Clearly there is a sense that we need to address this.

I want to do the descriptive part first. Coming back to you, Reed, since I know you spend a lot of time both thinking about and working on these issues, I want to ask you to start answering a question about how we came to be in what seems an incredibly fraught time, moment, and situation related to willingness to be vaccinated with this particular vaccine. Obviously there is the whole anti-vaccine hesitation—I shouldn't say "anti-vax" because that is demeaning in a way, but I want to ask you to describe why you think we are where we are before we get to the diagnosis and prescription part.

REED TUCKSON: First, if we look at it generically across the country, you are absolutely right. We have had this movement of people who have been organized against the precepts of vaccination in general. There is a growing distrust across the land in elites across the board, and we are seeing that distrust of elites in every sector of our society. It extends now into science. The word of scientists and the word of trusted officials is no longer accepted at face value by millions of people in the country.

Second, there are the pernicious effects of social media, where conspiracy theories and all manner of rumor and innuendo with no fact checking become the order of the day, and what we find is that there is no longer in America a true north. There is no place that most Americans can turn to have a common conversation on facts. This leads for those who have mischief in their minds—as we have seen through our elections process and other aspects of our lives—that mischief is now able to be conducted and circulated widely without any checks and balances.

Third, the behavior of the president of the United States has been abhorrent. There is a level of guilt that sits at his feet for having politicized this process that I hope history will judge so harshly as to disavow anyone ever of doing what he has done again.

Finally you have the specter of people of color, who themselves have had with their entire experience in this nation experiences that lead them to have a distrust of health care and a distrust of government.

One thing in the interests of time I would just want to underscore is the premise of the question. This is not an idle observation. This observation is so deeply entrenched that I fear that the disease of distrust and disinformation may be worse in many ways or as hard to battle. COVID-19 does lead to death, and it does lead to misery and suffering, but the disease of distrust is so significant that it is almost as hard to fight as the virus itself.

JEFFREY KAHN: Well said.

Ruth, I want to turn to you next. I know, Reed too, all of us have thought a lot about these issues in the context of research on human subjects. Of course we at Hopkins have a particular context in history. Maybe you can speak a little bit to the description about how we have come to this moment and the history that informs the kind of distrust that Reed just articulated.

RUTH FADEN: Thanks, Jeff.

I really liked your analysis, Reed, of identifying these four different streams that are obviously all interrelated. It underscores something I think that is very important to recognize, and that is that the groups of people who are concerned and thinking they will not take this vaccine is not one group. They are heterogeneous. They have different histories. They have different value systems. They have different epistemic commitments. They believe different things.

One strong focus I think that we need to have as we think about this is to recognize that because there are different kinds of people—there are the people who were anti-vaxers—and I will just use that term here because I think it's fine for some people who were anti-vaxers before this pandemic and before this vaccine. They have a deep distrust of vaccines and similar related technologies. Those people are where they are.

There are the people who are—let's call them "newly distrustful" of this particular vaccine because they are worried about either the pace at which it went or the administration under which it was developed or some combination.

Then—and this is the part I think, Jeff, you were referencing and that Reed of course mentioned importantly at the end of his four comments—there are people of color and communities of poverty who have had a long and horrible history, as Reed alluded to, that gives them reasons to distrust not only public health institutions and research in particular but wider American institutions, politicians, and systems. It has been rigged from the beginning and continues to be rigged against them, so this is the origin of systematic structural injustice of which structural racism is the paradigmatic illustration. But it is a rigged system into which poor people, people of color, and other oppressed minorities, gender and otherwise, find themselves. Now you have this vaccine that is being put out there for the African American community—I really would rather have Reed to speak to this than me—which has its own particular legacy with research involving human subjects and with public health institutions generally.

You mentioned for us at Hopkins parochially it is the Henrietta Lacks experience and experience of her family, which some in the audience may know. Certainly the Tuskegee syphilis study looms large. There is a term that one of our colleagues has coined, "a justified distrust." These are communities that are justified in their distrust, and to treat them otherwise, to fail to recognize that they are justified in their distrust, is counterproductive but also profoundly disrespectful.

I think it is terribly important that we tease out the different communities of people who are concerned or object or oppose vaccination and why. There is a different origin story in each of these cases with some overlaps. The way we respond both ethically and programmatically to these different sources of objection or resistance or hesitancy is very important.

JEFFREY KAHN: Great. Believe it or not, we are flying through this section of our conversation.

I want to ask Nicole and then Clive maybe on a more prescriptive level: What can we do, do you think, to reestablish trust? We have spent I think a fair amount of time in this section talking about the U.S. perspective, but maybe to the extent that you feel comfortable about it, you can speak to this in a more global health level in this part. What should we be doing to try to rebuild or reestablish that trust?

NICOLE HASSOUN: Sure. In the United States about half the population is expressing hesitancy about getting a vaccine. The major reservations concern safety, effectiveness, and approval processes of the vaccine. I think it is important to take those concerns very seriously. We do not want to politicize the problem. I think the problem of politicizing science lies as much on the left as it does on the right to accept that kind of framing of science as a thing you can claim. We need to focus on appropriate communication, compassion, listening to people, and understanding that diverse populations have differential access to health care.

Thinking about how we can address these problems, we might think about making sure that people of all racial, ethnic, and cultural backgrounds and types basically are included in clinical trials. That is important for scientific validity but also for encouraging trust in the process.

We need to have access to testing and immunization. We need trustworthy community leaders and partners. We need culturally appropriate education, translators, and support for people.

We have talked about the history a little bit of racism. I think it is important for us to understand that racism is not solely the responsibility of black people or minorities. It would be wrong to ask these communities just to be more trusting. We need to maximize transparency and explain that the purpose of participating in clinical trials is to help improve the health of the people who the trials are testing the vaccines on and ensure that they have appropriate support if they do get sick and that they provide the care for people.

Internationally it is not quite as bad of a situation. About 70 percent of participants I saw globally are hesitant, but a lot will listen to their employers. There are different situations in each country and different groups that might be hesitant. I think we need to have clear, consistent communication with everybody and explain how vaccines work, how they are developed, and how the regulatory process works.

For instance, the Centers for Disease Control and Prevention (CDC) says, in the U.S. context again, that when you approach somebody try to talk to them in a way that makes sure that what you saying is accurate, that you are credible, that you are empathetic, that you show respect, and that you tailor your message to recipients' needs. I think all that is really, really sage advice. That is all I have to say.

JEFFREY KAHN: Thanks.

Clive, your last comment on this section before we take on the global allocation and distribution questions.

CLIVE MEANWELL: Yes, very interesting comments.

I want to paint a starker picture of clinical trial participation. I have worked running ethics programs with people in the biopharmaceutical industry with Maggie Little and other people. We have run programs where we asked the biopharmaceutical managers and executives if their grandfathers should go into a diabetes trial and then role-played primary care, investigator, and IRB roles so that they could ask all the questions they wanted to. In a program of about 860 people, only two finally actually agreed that they would recommend to their grandfather that they go in the trial. That is pharmaceutical industry people who actually do have access to all of the information. I am not entirely sure whether we are as objective as we wish we could be about clinical trial participation, even if we are brilliantly informed as, of course, those 800 people were relative to most of us.

What I think we are lacking is the love and vulnerability aspects of this because I don't know about you, but I used to take my cues on health care from my mum, who would tell me what she thought I should do. As I got older, I realized she had some wisdom.

We have to take into account that a community will decide whether or not they take part in clinical trials. I am very heartened by some of the programs in, for example, hypertension, where if we are to look at African American communities where barbershops have been interesting places to learn different things from African Americans, particularly men in that case, getting haircuts and hanging out with their friends and learning things together and discussing them. That is the sort of initiative, if you want to cut through it, we are going to have to go way off the science here and work into those communities with mums and dads, with pastors, and with everybody else.

The idea of watching even wonderful President Obama and President Clinton, even if they lined up together and had their shots on TV, I think most would regard that as a bit of a comedy show: "That's nothing to do with my life. Of course they're going to get the right vaccine. They are former presidents." I wouldn't trust that.

JEFFREY KAHN: We can come back to this in the question-and-answer, since this is a pretty rich area that we did not fully cover.

The third topic that we identified to cover is global distribution, allocation, and prioritization. The way I think best to proceed here—and we talked about this a little bit before—was to start with Ruth for the descriptive part. She can tell us—with Nicole adding on, but Ruth will start—what is going on on the global stage, who is leading, and how are those groups thinking about global allocation, distribution, and prioritization?

I should say before Ruth takes the stage that she is a member of the Strategic Advisory Group of Experts on Immunization (SAGE) committee of the World Health Organization that is charged with making recommendations related to a framework for these decisions from the World Health Organization.

With that, let me turn it over to Ruth to do a summary to the extent that you feel like you can.

RUTH FADEN: Thanks, Jeff.

A slight correction, for my SAGE colleagues, I am on, with many other people, the Working Group on COVID-19 Vaccines to SAGE, which is the standing committee of the WHO that opines on all vaccines. Their way of operating is when a new vaccine comes up they name a working group to work on the issues and then present them with a slate of options, and then they make the final determinations, but it is actually the director-general of the WHO who makes the recommendations recommendation. So it is like for those who watch the CDC's Advisory Committee on Immunization Practices (ACIP) space, it is like the ACIP Working Group that then reports its recommendations to the ACIP kind of a deal.

In terms of the description let me just say that we have a mixed bag here from the standpoint of how this is proceeding. High-income countries by and large have already locked up and have pre-committed or pre-financed substantial supplies of vaccines for their own residents—and I underscore "residents" because I really, really hope it will be all residents and not only all legal residents of their countries. So a substantial amount of vaccine supply in the near term has already been bespoken by the United States, Europe, Japan, Australia—you can go down your list of high-income countries. The Chinese and the Russians are taking care of themselves, and we can go on.

Then there are the middle and low-income countries. This is where the COVAX facility comes in. COVAX is part of something called the Access to COVID-19 Tools (ACT) Accelerator, which is a global effort stood up by the WHO with support from largely European countries initially to both facilitate the development of not only vaccines but therapeutics and diagnostics. COVAX is the vaccine arm of the ACT Accelerator, but it is all three as rapidly as possible and with the aspiration of equitable access globally.

I am going to jump one second ahead to the diagnosis. The bottom line is there will not be equitable access to any of these three ways of combating the pandemic. This is really aspirational, and the question is how close can this global mechanism go towards approximating something that will not be equitable access no matter how you define or whatever your operational definition of "equitable" is. We won't get there. The question is: Will we be better off than before if we had not had this enterprise in place? The answer there is absolutely yes.

With vaccines in particular the goal was by 2021 to have in this COVAX facility sufficient vaccine to cover 20 percent of the population of all of the countries in COVAX. Let me just underscore that there are 189 countries as of yesterday in the COVAX facility. A chunk of them are not self-financing. They are what are called the Vaccine Alliance (Gavi) countries. Gavi is a preexisting organization that coordinates philanthropic support of vaccine distribution in low-income countries. There is a preset number of Gavi countries that are included in the 189 number, and they will receive vaccines essentially subsidized through COVAX with philanthropic support and the support of other countries that are participating.

Then there are a chunk of so-called "self-financing" countries that are middle income and a chunk of self-financing countries that are high income that make up the 189. It does not look like this goal of allocating 20 percent of population vaccine courses to all of the participating countries will be reached by the end of 2021, but it should be reached shortly thereafter. There are Monte Carlo simulations being run now at COVAX to look to see exactly where they are going to end up.

I already mentioned some of the wild cards in here. One of the wild cards is what role the Chinese and Russians will play, particularly with respect to middle-income countries. Another wild card is what high-income countries will do with vaccines that they "don't need." This is an ethics hot potato right now. The National Academy of Sciences (NAS) report—Reed was a member of the committee that developed it—made a recommendation with respect to excess vaccines. The WHO, the committee that I am part of, has made a recommendation. The European Union, a special group led by the French foreign minister it is my understanding is actually working on and has made a commitment that whatever counts as excess vaccines, and that is a very dicey question, for the European countries will be donated to the COVAX facility to distribute.

In the case of the United States, we are going to have wait for this new administration to see what position is going to be taken, but the preferred pattern for those of us concerned with equity is to have excess vaccine by high-income countries donated to COVAX to distribute through a mechanism that is at least centrally coordinated, but they could go bilaterally. I should underscore that the United States, China, and Russia are not participating in the COVAX facility at all.

NICOLE HASSOUN: China is.

RUTH FADEN: China is, sort of, but not clearly, fair enough, but not yet the way we would like. The Russians and the United States are out. That does not mean that they cannot—and the Russians would say they are approaching their responsibilities to middle-income countries and some low-income countries bilaterally. We will have to see. So another major recommendation for the United States and the new administration is that they join the COVAX facility.

Let me just say one more thing about the descriptive situation. There are a lot of modelers now trying to game out effectively what the impact would be for different ways of distributing out the vaccines that COVAX controls—or, if you imagine the perfect world where vaccines were able to be developed by a philosopher sovereign—in some fair and equitable way.

One of the interesting twists in this pandemic which makes it different so far from other pandemics is that the burden of disease is greatest right now in high and middle-income countries and not in low-income countries. This we have not seen previously, at least not in my study of pandemics. I am not a historian of pandemics as some people are, but it is throwing off the way in which we normally say that when there is a pandemic the hardest hit are always the world's poorest countries. For reasons that are unclear, at least in terms of health impacts, not necessarily economic impacts, there has been a disproportionate burden of death and disease in high and middle-income countries.

There is one explanation in part, and then I will stop, and that is because of age structure. Because of profoundly unjust background conditions that result in the fact that disproportionately very small numbers of people in very poor countries live to be old because they die of diseases that are managed well in wealthy countries and because the people who die in the greatest rates from COVID-19 are older, we are seeing lower death rates, in some countries almost nothing at all to speak of. They are thinking maybe there is underreporting, but it is still just a different dynamic. That is a little bit of an ethics head scratcher from the standpoint of how to think about global distribution of vaccine that I am just laying out there for us to consider perhaps in discussion.

JEFFREY KAHN: Nicole, I am going to come to you. I am going to let Nicole add on to what Ruth said and maybe do a little more diagnosis, unless you want to add to some of the description.

Then I want to signal Clive and Reed. After Nicole is done, I want to ask you to tell us what you think we can learn about what to do in this case from traditional—whatever that means—more historical approaches to distribution and allocation of new medicines, in particular new vaccines globally.

Nicole.

NICOLE HASSOUN: I guess I have a bit more to add by way of description. I think the most important thing that we need to do is have international cooperation. There has been a lot of vaccine nationalism. Countries are buying up these vaccines to use for their population. Canada I think has nine doses per person, and there is a question about what they will do with that capacity. The COVAX leadership is our best global effort to address the problem, but it is estimated that 3 billion people around the world who lack adequate resources like cold chain supplies, immunization campaigns, health care workers, and electricity will lack access to the vaccine for years.

COVAX is by no means perfect. They will let some rich countries vaccinate up to 50 percent of their populations before giving poor countries more than 3 percent.

There is a lot of collaboration there. The World Bank is offering some funding. They are also getting criticized because they may not be doing enough to help.

There are limitations that go beyond the immediate distribution plan in COVAX. The plan again is kind of inequitable because it only will give poor countries a little bit first, hopefully eventually up to 20 percent of the population, and you wonder what happens after that.

But even treating countries equally is I think not the thing we should do. I think we should focus on helping individuals, and that might mean giving a very unequal amount of resources to different countries, not 20 percent across the board, because the pandemic does not exist everywhere at once.

Competing proposals for fair distribution I think are likewise inequitable. I don't think rich countries should get to prioritize their populations first. I think the fact is that we should be supporting poor countries in these distribution efforts.

Just to recap from what I have said so far, to mitigate the negative health effects of COVID-19 we need to build better research-and-development and health systems around the world, so encourage generic production, minimize transactions costs, and help countries and companies tie rewards to the health impact of those investments. Then, to then address the pandemic and prepare better for future and ongoing pandemics, we need allocation principles that require countries and companies to cooperate to increase vaccine distribution, production, and consumption. Countries lack consistent energy supplies, delivery capacity, cold chains, and staff to administer vaccines, and there is no reason we should not set up a global distribution system to address this globally and prevent and address future pandemics as well.

International cooperation is essential not only for producing the vaccines and getting them distributed, but we need all that auxiliary equipment, health systems, and health workers to get it out there. Policymakers and manufacturers need trustworthy and transparent information campaigns to increase vaccine uptake, and we have to recognize that with globalization comes global responsibility. Pandemics just don't respect borders.

JEFFREY KAHN: Thanks to you both. That was really helpful in framing a super-complicated and obviously a big work in progress.

Clive, I want to ask you now to try to answer, maybe both in terms of what we can take away that is good and also lessons learned and not to be repeated in terms of how we have disseminated, shared, and invested in new medicines, especially vaccines, on a global basis.

CLIVE MEANWELL: A point was made earlier, which was interesting, which is that the diagnostic capabilities around the globe may differ. I think usually when data are being gathered at this speed we try to interpret them right away, but certainly later we realize that we may be using the wrong denominators or the wrong numerators. So I would just caution about whether we know actually just yet how many people are infected or how many people are dying. It is very unclear, so it is difficult to set policy on. "All models," which is the ultimate way of doing it, are, as George Box told us, "are wrong, but some are useful." But I do think we should be cautious about pre-reading our epidemiology data on the fly, as it were.

One fact of the matter, though, that is worth considering is that medicines and Coca-Cola are distributed fairly widely by the companies that make them or have distribution agreements in place. While it is tempting to put the mother of all distribution systems into the world it might be also tempting to simply bolt together existing distribution networks because this becomes neutral. Whereas the controversies of science and who gets paid and how much money they make are very fair controversies to debate, controversies of logistics are less alarming.

You need to get the stuff to the place as quickly and faithfully and have the appropriate storage conditions as you can, and then someone on the end of it—the last mile is always the hardest—needs to be adequately trained, and I really mean "adequately" trained, to stick it in someone's arm. As a physician who has done that quite often, it is not that hard, I can assure you, as many of you know. Is it possible to teach family members and community leaders how to give the simple deltoid intramuscular injection? Absolutely, with the right type of simple syringe setup.

So, rather than thinking that this is all going to get done through the health care system or some clinic or something, we should again think of this as a community-based problem where families and family-trusted community leaders literally have the syringe in their hands because they will be trusted. If my mum said, "Stand there, I'm going to give you a shot," I would stand there and get my shot.

I think you need to be very practical. Coca-Cola has learned how to distribute their drink all over the world. I don't know if Coca-Cola is going to be involved in this, but they also know how to distribute chilled things. Drug companies do it all the time. They just have to be asked to do it because I don't think we should make distribution controversial.

The top-down question of where it goes I don't think the industry is in any condition to answer. I think someone has to figure that out, people who are wiser and with a broader view than maybe commercial organizations. But if called to action, I would predict that you would be stunned by the quality of distribution that is available because it is there already. But don't reinvent it. I don't think you have to build it as a public service. Go ask someone to do it for you, and tell them to do it for free, because now you are working with commercial organizations in their own communities, and that is where, should we say, they want to shine their light. I would be pretty ambitious and fairly optimistic if we could tap into the commercial entity.

I do worry, even though I am very happy about the change of administration, because of the political cost of this change that there will be a tendency for administrations around the world, not only here but in Britain, in Germany, and across the European Union, to feel they need to distance themselves occasionally from industry for obvious reasons. I really think this is a situation in distribution and logistics where people shouldn't be afraid of that. That would be the way I would take it on.

JEFFREY KAHN: Really interesting. There was a [CNBC] story this morning about Kroger—I don't know if people heard this—being good at supply chain and keeping things cold, and that may well be a place where vaccinations happen. That is giant grocery chain, of course, in the United States.

Reed, your thoughts on this. What can we take from what we have done before, either good or bad?

REED TUCKSON: I think what we learn is that there are five main categories of things that have to be attended to:

(1) There has to be prior planning. I think if we have learned anything, you cannot start de novo from a standing start. There has to be an infrastructure in place and a pre-planned activity that can then be drawn upon. The transition from the Obama administration to the Trump administration is a perfect example. When an incoming administration ignores the work done before, you have a disaster.

(2) You have to have a clear sense of population group prioritization: Which folks are the ones that you go after the most, given the nature of the challenge? And each of these challenges are different. Sometimes pregnant women and children are going to be more important than something else. So you have to be clear about understanding how you make those prioritization group challenges.

(3) You have to be clear about the infrastructure resiliency, your supply chain resiliency, and the monitoring of the effectiveness of the supply chain in real time, with particular focus on physicians at the community level and how those will relate to other elements, because it is the community-based infrastructure that if you bypass it—although I love the idea of the Kroger system and the fact that we are doing all this work now with pharmacies being intimately involved with this, what is the relationship between the pharmacy doing that and the local on-the-ground docs who are competing against pharmacies for their ability to stay in business? These are fundamental issues.

(4) There has to be, we have learned, extraordinary communication at the community level, and there have to be skill sets at being able to communicate information with trusted ambassadors and intermediaries but also being able to communicate information in ways that people can understand.

(5) The financing of the effort needs to not only include, as we have learned from past experiences what government puts in, but also how insurance works, both Medicare and Medicaid public insurance but also private insurance. One more wrinkle on private insurance is that because of the preponderance of employer-sponsored health insurance, what will they do? This came up very much in the H1N1 experience, where we faced such real challenges around whether or not the administration of the vaccine would be a cost borne by the individual patient or by the insurance company or the self-insured employer.

It is all five of those elements to me that I think we have learned are all important, and each of them will play out in different ways, depending on the nature of the threat, except for the first one, which is, there has to be in place comprehensive prior planning that allows you to pivot, depending on the scenario du jour.

JEFFREY KAHN: Wow. Super-interesting from everybody.

We have no a little over 15 minutes for Q&A, which I think will follow on well. I am trying to curate a little bit.

Maybe picking up directly on Reed's well-crafted five points, there is a question here from Ford Rowan. Ford is a member of the Berman Institute's advisory board and a former journalist among other things himself. He invokes a little history too from the H1N1 experience, when in the state of Maryland, led by a group at the state health department and at the Berman Institute that Ruth was involved with—and I will ask her to say more about it in a second here—went through a process of town hall meetings to try to assess the community's feelings about allocation of scarce resources, in that case, ventilators. As you may remember with H1N1 the worry was that we would run out of ventilators, much as we worried at the beginning of the COVID-19 epidemic, so using that method to seek community engagement and community input about the right way to allocate scarce resources when there are just not enough to around. Maybe not exactly a parallel, but using that kind of methodology to seek public input about how people feel about vaccine safety.

That is a little bit of what Nicole mentioned in one of her answers. Maybe I will ask Ruth first to say two words more about that effort, since you were deeply involved with it. I only showed up at the tail end of that. So, first to you, and then maybe to ask Nicole to weigh in, and then Reed and Clive, in that order.

RUTH FADEN: Thanks, Jeff, and thanks, Ford, for the comment and the question.

This was a process we undertook right after the H1N1 scare had passed, and we realized we were not going to run short of ventilators, but we had been doing all of the intense planning, as so many places were on the ethics side, the Intensive Care Unit side, and every other sort of side to figure what were we going to do when we ran out of ventilators, and we never did. The whole time we were doing this we were feeling very stressed because we did not have an opportunity in this compressed period of time to engage with the different publics that make up the state of Maryland and figure out where they were. We expected to find out that different people would be in different places.

Once it was over—and this speaks, Reed, to your first point, prior planning—with all good intents, we said: "Okay, let's not get caught flat-footed again. Let's go ahead and go through this process," which we were able to do. We can maybe share the paper and the other papers that have come out since then for others who want to pursue it. It was a very important experience, and we ended up with a plan that was not perfect. A group that Jeff was part of for Hopkins then took it and made it better.

The relevance to right now I think is that while Reed's committee, the nascent committee, did take public testimony—and he can speak to the importance of that in your thinking—I am not sure what ACIP did. I am going to stay with the United States for a moment, and then we can talk about this globally as well. The details of what actually is going to happen in terms of prioritization are going to be worked out at the state and local levels, and there is still opportunity at the state, local, city, neighborhood, and county levels to engage with people through a process like we engaged in or otherwise for lots of reasons. There are multiple good ethical and prudential reasons for substantial community engagement at this point. It is a heavy lift, but it needs to happen now, and it needs to be resourced, which is a piece of the challenge.

I think one way of framing it that some of us have tried to emphasize is that it has been such an important pivot to say we are now going to have science-based policy, but science and the evidence it produces are empirical facts about the world that still need to be mediated by the values that we are trying to accomplish and in some cases need to trade off in this prioritization sort of context. If we open up the conversation so that we legitimize the expertise of people who are not scientists—that is to say they are just people, but they have values, and those values are really what matters in helping us figure out what to do with the good science.

How should we think about this? Is it right that we should prioritize people who are at greatest risk of severe disease and death over essential workers, or should it be the other way around? That is not a science-driven analysis. That has to be informed by the values of the people who are going to be affected by these decisions.

I will stop there by saying I hope there is still time, and I am sure that some local jurisdictions are already moving in this direction. I know, Reed, you are involved in at least one or two initiatives like that that maybe you can share with us, but I don't want to go outside of your order, and I know Nicole has thoughts here as well.

JEFFREY KAHN: We can follow on Nicole.

NICOLE HASSOUN: Yes. I also have something for Reed.

I think the importance of community engagement is something to stress. I am going to step back to what you said initially, though, Ruth. I think there is a scarcity mindset, so this will be an unpopular comment, but in a pandemic people tend to think, Well, priorities change for doctors and society from individual patient care to maximizing the benefit for the majority, something like the common good, and then we have to prioritize to do that.

I actually disagree with that idea. I think what we should do is take those individual concerns seriously and try to respect human rights in that process. This shift to utilitarian thinking is a problem for me.

I think what we should when we face these tragedies when it seems like we cannot have enough ventilators and cannot have enough vaccines for everyone is have what I call "the virtue of creative resolve," which is this fundamental commitment to trying to think around the problem, solve the problem, or avoid the problem. So rather than spending a lot of time deciding exactly what allocation principle is right, often we can solve the problem by getting on the phone and calling somebody at other health systems and borrowing ventilators or sending people elsewhere.

There is this background to this thing I am going to say, but with that said we do have to prioritize things because there are going to be tragedies where we have to decide who is going to get it first. I think it is important to get clear on those values, to get clear on what matters. I don't know to what degree it should reflect the values of the society that holds it. I saw something on the ACIP committee report that is deciding how we are going to allocate resources or recommend vaccine distribution in the United States suggesting that people do think we should prioritize the elderly, which is not what the National Academy of Sciences and the ACIP seem to be recommending. I would like to hear Reed's comments on that, the mere fact that people seem to have different priorities than the scientists, if there is evidence of that, if that is something to be taken seriously.

I do think we need to subject those values to critical reflection, and there are times when we are really clear about what it is we are trying to achieve. We are going to have the best global health impact. We are going to have the most lives and alleviate the most disability or save the most life-years or whatever. If we get clear on our objective, we can often do a good job of saying: "Okay, what is it that is going to help us achieve that objective?"

But there are those times where we need to step back and ask: "Does this respect people? Is this a respectful policy as individuals and not just aggregating the most good?" It is a complicated discussion I guess is what I'm saying, but I am interested in what Reed has to say about the way that he is thinking about values and the ACIP and the National Academy of Sciences are thinking about how values should enter into that discussion and reasonable disagreement about whether we should prioritize the elderly or something else.

REED TUCKSON: I appreciate the opportunity. I am not sure how much light I will add, but let me just throw these out:

One thing that this pandemic is teaching us at this particular moment that comes out of your comment just a second ago is that there is no backup from any other state. Everybody is now maxed out. You are really in a bad situation. Every single state's hospitals are now maxed out, and you cannot call in the cavalry from Wisconsin to go help Wyoming because everybody is in trouble.

I think the key thing here is what are the goals, and you just hit it very much. Is the goal to get people back to work and get the economy going, which has its value? Is the goal to get the schools back open so that the kids can get back? Is the goal to try to reduce morbidity and mortality? Each of those are different, so there is going to need to be a clear sense of what are we trying to achieve.

The thing that is obvious is going on is it didn't matter and it doesn't matter that the National Academy made its recommendations or that the ACIP made their recommendations because ultimately this is all going to devolve to the states. The states are going to do what they are going to do.

The advocates for people of color or marginalized populations or others will have the National Academy of Medicine report, will have the ACIP report, to use as they advocate for changes to the decisions that a state may make. But what I am particularly fearful of is that what the states will do, and particularly politicians, will pander to their political base or they will pander to the need to show that they are doing well by distributing a certain number in a certain time period.

If you are looking for ease of administration and good reportable numbers that say you have injected X number of arms in X period of time, African American and other marginalized communities may not make it as easy to get those numbers as some other communities. So what you may well find is that at the local level decisions will be ultimately made that have to do with political expediency or looking good in the media versus the goal of immunizing those who most need to be immunized. So I am very fearful of what happens at the state level.

Last, I think that in so many of the states we have seen if you look at the election kinds of results and the way in which activities have been implemented by states to suppress votes from particular communities, I don't think it is a very big leap to think that those elements, those biases, and those preconceptions will not enter into the dissemination process for the vaccine.

JEFFREY KAHN: Clive, any thoughts on this? It looks like we are going to only have time for this last bit, unfortunately. We used up our time.

CLIVE MEANWELL: I will be very, very brief.

I think the comments made are fantastic. I would add only that we should be so lucky. If we have enough vaccine made quick enough to be able to make these choices and execute them in batting order, I will be thrilled.

But I am afraid, although we should follow all these principles, whatever they become as a consensus, we should just get started injecting people. Because this is a global pandemic, frankly whether it is the Upper East Side of New York City or the upper east side of Somalia, let's just get started. I hope we will have enough vaccine to be smart about it, but I am afraid we won't for at least a year or two.

JEFFREY KAHN: We have five more minutes. I am going to try to collect here from among the questions in the Chat.

A few things related to herd immunity: What level of population immunity do we need to get to to achieve the public health goal? And what do we think as a group about people relaxing their behavior, knowing that a vaccine is coming? Do you expect a surge as a result? That's one.

Second, how will states prioritize? When an allocation comes to a state, do they get to distribute as they wish, or how will that happen? I know that all 50 states have been required to submit their prioritization plans to the federal government. That has all been done as of the middle of last month, so there are criteria within each state. They are not all the same as each other, but they are fairly parallel.

What else? Maybe we will just start with those. Who wants to start?

REED TUCKSON: Two hundred million is probably the number of people who need to be infected and/or vaccinated to be able to get to that herd immunity in the United States.

JEFFREY KAHN: That's a lot.

REED TUCKSON: We have 14 million infected now. You do the math there. We have a long way to go.

JEFFREY KAHN: And the message to take from that is: Don't relax.

RUTH FADEN: Don't take your mask off, yes.

Can I just add that some of the latest discussions that I have been involved in are keen to find out whether these vaccines have any impact on transmission, and if they have transmission-blocking potential, you may be able to get away with fewer people being immunized and still get to something like herd immunity. That is a global and also country-specific question, but right now we have no evidence that these vaccines interrupt transmission, so we have to keep our masks on and hope that lots of people agree to be vaccinated.

REED TUCKSON: That is such a key point. When we think about and look at the data for effectiveness of the vaccine, we have to be clear about what individual vaccine candidates' attributes are, and that sense of does it stop transmission, and also does it reduce severity of illness once infected. There are several elements of those, and I think what happens is we start talking about this in the public discourse as if it were just one thing.

RUTH FADEN: Exactly.

REED TUCKSON: We have to be more clear about that, and I am glad that Ruth brought that up.

JEFFREY KAHN: I would say too that stopping community spread—your answer, Reed, was for the whole country, but of course it will be a locally determined matter too. There is a way of making people's self-interest part of the equation here, if you want your kids to go back to school or if you want to go back to work. We need to reach whatever that threshold is in our communities, and over time that will mean the whole country.

I see Joel, which makes me think we are trying to wrap up. Is that true?

JOEL ROSENTHAL: We are near time, Jeff. Do you have some concluding remarks?

JEFFREY KAHN: I don't, but I am sure others may want to chime in a little bit yet.

RUTH FADEN: I just wanted to say one thing and then I will stop about the scarcity question. I think it is important to underscore that while we are wrapped up and tied up in knots about prioritization within the United States—and I am mindful of your reservations, Clive; it is a big set of assumptions that people are feeling good about that maybe they shouldn't—but at least right now the projections are that we will have sufficient vaccine in the United States. We will have enough. It is just a matter of waiting for when your number comes up, but not whether it might not come up at all, whereas for most of the world that is not the operative premise. The operative premise is that there will be vaccine in short supply potentially all the way through to 2024. The point is, when people are planning for prioritization in some parts of the world it is not when, it is ever; which groups will get vaccine, full stop. That is a very different context when we are trying to make these difficult ethics/community values tradeoff decisions, and it needs to be underscored. We are privileged yet again in terms of the nature of our problem.

JEFFREY KAHN: This has been a really interesting conversation for me and I hope for all of you and the attendees, of course.

Over to you, Joel, for whatever concluding remarks you might have.

JOEL ROSENTHAL: Jeff, thank you very much. I just want to thank all of you on behalf of the many people who have been listening in. It was a wildly ambitious agenda, and we covered vaccine development, we talked about distribution, and we talked about this important issue of trust. I can see that this is going to be an ongoing conversation, so I hope I can call on you in the future to continue some of these conversations and crucially to share some of this information with our constituents and a growing constituency of people who are interested and concerned about these issues. I hope that the Berman Institute and Carnegie Council can do more of these types of events and perform a public service in that way.

With that, we will conclude this session. We do "live online," as it were. Come to our website, the Berman Institute website. There are lots of resources there, and I am certain there will be more coming along the way in the coming weeks and months.

With that, we will adjourn the session. Thanks again to everybody who participated.