On October 2 the US National Academies of Science, Engineering, and Medicine issued its consensus Framework for Equitable Allocation of a COVID-19 Vaccine. William H. Foege, MD, MPH, emeritus distinguished professor of International Health at the Rollins School of Public Health at Emory University, cochaired the committee that authored the report and discusses its recommendations. Recorded October 2, 2020.
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>> Howard Bauchner: Hello, and welcome to conversations with Dr. Bauchner. It is Howard Bauchner, editor-in-chief of JAMA. And what an honor today to be joined by a living legend, Bill Foege. Welcome, Bill.
>> William Foege: Thank you.
>> Howard Bauchner: So for people who don't know, Bill was director of the CDC from 1977 to 1983. He's been a principal adviser to Bill Gates who established the Bill and Melinda Gates Foundation. And he was awarded the Presidential Medal of Honor from President Obama, and is one of the principal architects for the eradication of smallpox in the world, probably one of the single greatest public health achievements in the history of mankind. It's been an extraordinary career, Bill. So thank you for joining me today.
>> William Foege: Thank you for having me.
>> Howard Bauchner: So earlier today, the National Academy of Medicine released a consensus study report entitled Framework for the Equitable Allocation of COVID-19 Vaccine. Bill was the co-chair of the committee. It's a long list of a who's who of a national representative group of important individuals in the US. Before we get into the recommendation, Bill, could you say something about Helene Gayle, your co-chair of the committee?
>> William Foege: Well, Helene Gayle has been a colleague for many, many years. She came to CDC, and I actually talked her into leaving CDC when she was in charge of a billion dollar budget on HIV with hundreds of employees. And I said to her I can take you away from all this, and into a secure place where you only have to supervise one person, and you have no money. But I said you have the opportunity to influence the most important person for HIV that you can imagine. And she came. And the Gates Foundation did get involved in a big way in HIV. For example, Rockefeller Foundation put up $10 million to start a program looking for a vaccine for HIV, and Seth Berkley became the director of that enterprise. Bill Gates then matched that with $100 million because he said I trust the Rockefeller Foundation, that if they're willing to put that amount of money and they've studied this, and he put in $100 billion. He ended up when we proposed six different possibilities of things in AIDS. And at a time when he really wasn't that interested in getting into another new program, he ended up in 20 minutes telling us to do all six things. And it was such a spectacular change in what we were doing, that I asked his father on the way home from that meeting, tell me what happened. Because at the beginning of the meeting, he said, I do not want to do things that are, turn out to be money down at rat hole, that if I invest this year, I have to invest next year, and then I'm tied into it, and things like that. And I said he did not want to do this, and 20 minutes later, he says, do all six things. And I said what happened? And his father said, he's a businessman, he knows what he wants. He wants a return on his investment. And he knows what that return looks like. But when faced with the human condition, he'll always make the right decision. And I said to myself, I'm working at the right place right now.
>> Howard Bauchner: So the equitable allocation of vaccines. So let's put aside, we don't know when a vaccine will be ready. We don't know if in fact, it will be more than one vaccine. What framework did you try to work from, Bill?
>> William Foege: These were 18 people, and you can expect they're 18 opinionated people. [Laughs] They come from different backgrounds. They have different experiences, and they have ideas on what should be done next. But from the beginning, we decided this is not the Supreme Court. We won't have a minority opinion. And we will flesh things out until we agree, or we won't put them in. And leave it or not, two months and one week after our first meeting, all on Zoom, two months and one week after that first meeting, we had our report written with everyone agreeing and signing on. I mean, it was an unbelievable experience. Good people, knowing what the objective is, wanting to improve what happens in this country and around the world, because we were asked to look at the global situation also. They were able to come up with a report. Over and over I just would shake my head as someone would come up with an idea that really solved the problem.
>> Howard Bauchner: Now the report is long. It's over 250 pages. I've been able to glance through the executive summary since I received it early this morning. What would you say when people ask you, how are the first hundred million doses going to be distributed?
>> William Foege: Well, I would tell them that the discussion on how to do that started out with ethics and equity. Now, you and I have been on committees before, scientific committees, and we oftentimes start with the science. And then, when we have come to some conclusions on the science, then we address the ethics and the equity. This group started with ethics and equity, and developed a framework. And then they asked the question, with individuals what is their risk of getting the virus? What's the risk if they do get the virus of being sick, hospitalized, dying? What's their risk of transmitting this? And what are the things that could change this, like, the ability to use a mask and so forth? And from that, then came up with the criteria of who should go first. I think one of the big surprises people expected, since this is a disease that is hurting minorities more than others, people thought we would come out with minorities as the first group to get the vaccine or the elderly. With minorities, we do not say that. We instead say the problem is not race. The problem is racism. And that if you look at the problems, individual problems, the individual risks of people who are in minorities, then like the majorities also, and there's a whole list of them, but there are three of them that are really at the top of the list, that's heart failure, kidney failure, and a body mass index over 40. So what if you aim at those things, and then, you look at what are the social vulnerabilities, not just the personal vulnerabilities, but the social vulnerabilities? What does it mean to live in a crowded house, three generations in a house, inability to work from home, every day having to take a risk of facing the virus, having problems with transportation, school children coming in and out? And so, we said let's look at the risk factors and make those the decision point for getting vaccine rather than saying race, because the virus simply doesn't understand race, color, it does understand vulnerabilities. So that I think is a big, unexpected.
>> Howard Bauchner: And that may prevent legal challenges to the allocation scheme because allocation schemes based upon race alone may end up being, may being challenged legally so there're other important reasons to have done that. Are our healthcare workers considered a priority?
>> William Foege: Yes. When we finish going through all of these risk factors and what are the mitigating things, the healthcare workers are first priority, they're in the first phase. And this is another thing, instead of calling things tiers, we call them phases, because with a tier I can see someone above me that is holding me down because they have a priority.
>> Howard Bauchner: Right.
>> William Foege: With a phase, I can see someone in front of me that has a reason for getting the vaccine for pulling me along.
>> Howard Bauchner: Right. Yeah, the language, the choice of language becomes very important.
>> William Foege: Right. And so, I'm pleased with the way that happened. But the first phase is divided into two parts. There's the jumpstart phase, but we don't have much vaccine, those are the health workers. Not just the doctors and nurses, but janitorial staff and all of the people working in the hospital that could be exposed to the virus. Why? Because, not because one person is more important than another, but one position may be more important than another because it ends up protecting people down the line. It keeps a facility going that's taken care of not only coronavirus patients, but other medical conditions. So their personal list also included our first responders because they oftentimes, while they can have masks and so forth, they're oftentimes in situations where they cannot, in fact, if they're trying to give CPR, they get exposed. So they were high on the list. The other part of the first phase turned out to be people that have comorbidities, and are really at high risk. By the time we get down to the second and third phase, we're looking more at transmission of the virus than at mortality and morbidity. But from the beginning, we decided this is not mortality being the most important thing. It's the combination of mortality, and suffering, and transmission, and what it does to society, and try to come up with a solution that puts those together.
>> Howard Bauchner: Bill, is there an estimate of how many are in that first phase, the number of individuals?
>> William Foege: Yes. We estimated that about 15 million people. And if you're looking at two doses, that would be 30 million doses. And we decided that you do not start with 30 million people. You, in fact, if you get started with 15 million, you wait, in order to use that second 15 million doses on them. It doesn't do any good to partially protect people.
>> Howard Bauchner: Right. So if the company delivers 30 million doses, in theory, those would be retained to go to those 15 million healthcare workers?
>> William Foege: That's right. And with these different vaccines, you know, two of them require refrigeration at minus 80 centigrade, which is over 100, minus 100 Fahrenheit, you really need special facilities to do that. This is not something you'll do in a pharmacy or in an immunization clinic. This will be at medical centers. And so, if those first vaccines turned out to be those kinds of vaccines, then it'll be easy to be able to do the first responders and the medical people right there in medical facilities.
>> Howard Bauchner: Yeah, I had another conversation last week with someone, and I came to realize the benefit of this phase one is that those vaccines will go to hospitals. And hospitals, in theory, should be able to do the storage at these unique temperatures, unthaw the vaccine and then give it. When you move out into the community trying to, and I'm a pediatrician, so I even know pediatric practices struggle, and we do vaccines all the time. So once you leave the hospital, if you have a unique storage capacity, it's going to be a problem.
>> William Foege: One of the vaccines will only require refrigeration, the Johnson and Johnson, and a single dose. And so, then the question is if you've started on the other vaccines, and this one comes along, then what do you do [inaudible]?
>> Howard Bauchner: Right, that's a question already. So you can already answer the first question that's come in. Do you switch vaccines or you just stick with the first vaccine?
>> William Foege: I think you have to stick with what the person started with, and not say, we're going to experiment with two different vaccines and see what happens. And then, also, as a pediatrician, you'll appreciate the point that when we finish the phase three studies, there won't be a single --
>> William Foege: -- person under 18 that's been vaccinated.
>> Howard Bauchner: Right. Yeah.
>> William Foege: And so, what do you do about that? So many of these questions, ACIP is the Advisory Committee on Immunization Practices, will have to come up with a solution to, and our group was not asked for that kind of a solution.
>> Howard Bauchner: So Bill, we get through phase one sometime in the first quarter of next year. I mean, we could all speculate whenever that will be. You know, I'm talking to Peter Marks on Monday at the FDA about how the FDA will handle an EUA application. But let's say we get through phase one sometime in January, February, March, what's phase two look like, Bill?
>> William Foege: I think once the vaccine is at that point, we're suddenly going to get a lot of vaccine.
>> Howard Bauchner: Okay.
>> William Foege: And probably competing vaccines. And even though we put these in specific stages, we might move through stage two to stage three relatively fast. The problem is not going to be, I think the limitation of vaccine, it's going to be the hesitancy of people wanting to get the vaccine. But in stage two, we include such things as jails. Some people do not want to see prisoners vaccinated before other people, but they don't have mitigating possibilities. You can't keep six feet away. You have to treat them as being at higher risk and put them in phase two. We also have school teachers and staff, but we don't know what to do about students. And so, you can protect the teachers and the staff. But if you're not vaccinating the students, they're going to take this virus home with them. And so, many of these problems, we end up saying, here's a framework, a federal framework, but it has to have much flexibility at the local level.
>> Howard Bauchner: Bill, how do you have a sense of how you'll get to the 65 or 70-year-olds? Some who live at home and some who are in nursing home and skilled nursing homes, and we know that the data about the elderly, the frail elderly in nursing homes, it was devastating in the early months of the pandemic. I mean, even now, the numbers are 45, 50, 55% of the deaths are from people who are older and frail. Do they come into phase two or are they a phase three group?
>> William Foege: Interestingly, the model showed you can save more lives by vaccinating the workers in nursing homes rather than the residents. You in effect do a surveillance containment project on a social level rather than an individual level. So if you don't have much vaccine, the people working at the nursing home actually come with other health workers in phase one. But then, the residents would be in phase two. And so, people with comorbidities or the elderly will come up higher on the list. Now, here's the other thing. I'm 84 years old. I have comorbidities. I do not think I should be close to the front of the line because I can work from home. I don't have people coming in and out. I don't have someone working outside and coming home every day. So you also have that to balance. But then, by the time we get to phase four, someone asked well, why do you have a phase four because you don't have many people in it? We have to make sure that there's an understanding everyone who lives in this country. And they can be residents, they can be immigrants, but everyone living in this country is eligible for vaccine. And phase four, we'll make sure that everyone gets it. Plus, I think the hesitancy issue may not be a permanent hesitancy when people who should be in phase one and phase two don't get their vaccine, and a high percentage of Americans say they will not take the vaccine. When they see that the vaccine is actually working, they may change their mind, and so we have a phase four that will click all of that also. But an important point here is vaccine is not the silver bullet, that you have to continue everything else. And I make the point that if we had a vaccine that was even 70% effective, which is pretty good, 30% of the people getting the vaccine will not be protected, but they won't know that there's a 30%. And so, they have to continue using masks, and distancing, and washing hands. And so, vaccine is added to what we're doing. It doesn't supplant anything we do.
>> Howard Bauchner: Yeah, I can emphasize that enough. That's coming up more and more. So 330 million Americans, 70% would be great. We don't know how long it lasts. That we'll figure out after people have been vaccinated and we follow them. But at 70%, it means 100 million Americans, 100 million people living in the United States, even if 100% were to get vaccinated will not be protected, and you won't know who they are.
>> William Foege: That's right. That's right.
>> Howard Bauchner: Bill, given all the data that you saw, and I know you had many consultants from different groups, do you have instincts about when a vaccine may be ready? What your sense of when we'll begin to see the vaccines be approved?
>> William Foege: Well, I will not be surprised if we see the first vaccines by the end of the year, but in small amounts. But then I think it will ramp up pretty fast in the first quarter of next year. That's what I think. There are lots of things that can go wrong. And even getting through phase three to have enough people exposed to know how good is the protection, we don't know how long that will take. So, but you also, when you were talking about how many people would take the vaccine, but not be protected, you know, it takes us into this herd immunity question.
>> Howard Bauchner: Yeah.
>> William Foege: Because when I started with smallpox, I was told repeatedly the herd immunity level for smallpox was 80%. And this was a good vaccine. I mean, a vaccine that close to 100% effective.
>> William Foege: If you didn't get to 80%, smallpox will stop. Well, India used the herd immunity approach for 150 years, and they had repeated smallpox programs. And each time, a group would come in from the outside, give them advice on what to do, and then, a group would come at the end of the program to assess it. And the advice always was to get to 80% coverage. And then they'd come back to do an assessment and they could show they hadn't reached 80%, because the vaccinators would go to the easy-to-reach [inaudible] and easy-to-reach groups two or three times rather than find the hard-to-reach groups. And so, they weren't getting to 80%. The last program they had, believe it or not, experts from WHO, CDC, and other countries said, well, here's your problem, you're not reaching 80%. So set the goal to be 100%. Well, if a country can't reach 80%, they're not going to reach 100%. So we went to India with a different approach, which is find the virus.
>> William Foege: And just vaccinate around the virus. And in May of 1974, at the peak of smallpox, one state alone was having 1,500 new cases each day, which meant 1,500 new investigations every day with contact tracing, which we did, with no smartphones and no computers. And we were able to do in India at that time, contact tracing, a magnitude that you can't imagine, and somehow in this country, we're told we can't do that. And here we have millions of tests being done that are useless because they come back so late, you can't really use them for contact tracing. So there are a lot of things that have gone wrong. This idea of herd immunity, if you have trouble getting it with a vaccine, you're going to have even more trouble trying to get it with disease, and it just is not a plausible approach to this problem. Howard Bauchner: Yeah, well, the estimates I've seen are, you know, so variable, 40%, 50%, 80%. I think the key will be how long the immunity lasts from the vaccine. And I think that remains one of the great unknowns. You know, do people get two doses and have protection for three months, six months, or a year? Because if everyone needs to be revaccinated after three months after the second dose, it's going to be a long year or two until we really are able to vaccinate everyone and really protect everyone. If immunity lasts for six months or a year, that's a very, very different story than three months or six months.
>> William Foege: And you know, we can be happy with how few cases have actually come up a second time. And, you know, most of them have been well-investigated, and there haven't actually been a second. So I think we're getting close to thinking, well, we have six months of immunity anyway. And it may go longer than that. But then the question is, what's the immunity of a vaccine versus a disease? And so, many uncertainties in all of this. And I started the preface of our report quoting Richard Feynman, "Certainty is the Achilles Heel of Science."
>> Howard Bauchner: Yeah, I saw the first sentence. Two other questions, Bill. You know, I don't know if there was a heyday of the Centers for Disease Control and Prevention, but it's a world-renowned, a world-renowned group. I have many friends and colleagues there. One of my mentors, Jerry Klein was an EIS officer, and Jerry and I have remained friends for many decades. It's been a very difficult six months for the FDA. Early on, there were some errors. They've had a kind of difficult time interacting with the executive branch. As a former CDC director, what's been your impression, Bill?
>> William Foege: Well, it is a difficult time because in a paper that came out last week, which I wrote four months ago, I point out that we've learned many lessons over 75 years of disease control. And almost every lesson has been violated with this, the worst pandemic that we've seen in our lifetime. And the first lesson is, know the truth. You can't control an outbreak unless you know the truth about it. And we're in a position now that people are never sure about what is the truth. And they go to universities rather than CDC to get their truth. And this just hurts me more than I can tell you. And in CDC, the workers are still as dedicated as they've always been, and they're working as hard. But there is now a political interference that has made it difficult for them to do what they've done in the past. So know the truth is first. Number two, you need a good surveillance system in order to find out the truth. Number three, you need coalitions, no one can do anything on their own. And coalitions have not been a strong feature in this. Number four, you need national plans. You cannot leave this to 50 states, each one trying to develop their own plan, and we've not had a national plan. And so this is a deficiency. Number, next number, you have to be looking globally. You simply have to work with WHO. And in our report, we make a case of this that the United States has to reenter the global health community, provide leadership, but also get information so that we can track this virus and know is it mutating to a point where the vaccines may not be good? We have to have this as a global effort, we can't do this alone. And in the worst case scenario, what if none of our vaccines actually work, and we had to go on the world market to buy a vaccine? If we're not part of that world assembly, who will want to actually sell to us? So there are lots of lessons and we violated every one of them. And it's been because of political interference.
>> Howard Bauchner: Quite a few questions just came in, Bill. So I just want to ask you one or two more, and then I'll ask you my final question. You touched on vaccine hesitancy. You know, I see all the different polls, 40%, 50%, 60%, but we certainly know more than a third or 40% of the population have expressed hesitancy about a vaccine, I think in part because of the confusion about the approval process. I think some people recognize these are truly novel approaches to creating a vaccine. Historically, black Americans have had hesitancy about vaccines. What's the concerted approach that we need to have? You just talked about kind of having a single message, what should that message be, Bill, and how do we get there around this vaccine?
>> William Foege: Well, the message has to come from people trusted by those subgroups. Now, Reed Tuckson has talked about for the black community we need a consortium of the four black medical schools, and the black churches, and the National Medical Association, and the people that the African American population could in fact respect. The same thing in the Latino community, that it requires people they trust. So if you come up with a message that says, we're going to provide full transparency on how this vaccine is made, what the results have been in using it in people and who are these people, and we allow everyone to ask questions about it, I think we can reduce the hesitancy level. But it won't be done by a federal government that tells people they should have to take vaccine. People aren't trusting the government that way, so it has to be like black medical schools and the black churches that are engaged in this and invested in this to make it happen.
>> Howard Bauchner: The last question in some regards has two parts. Bob Redfield and Tony Fauci have been quite outspoken about the need to mask and socially distance on a very consistent basis. Late yesterday, early this morning, at least when I woke up, it was reported that President Trump has been infected with COVID-19. He's clearly been hesitant about masking. That's quite obvious. He claims he masks periodically. It's been difficult to know when that has occurred. How do you think that's going to play out over the next couple of weeks? Vice President Biden has masked. He surrounds himself with people who've masked. That's less true for President Trump, and he was infected. How do you think about that, Bill?
>> William Foege: First, I have to tell you, it's saddened me a lot just to hear that the two of them were positive. I just, it doesn't help anything that I can see. But on the other hand, I'm sure that it will change the perspective. This may turn out to be one of the most important things that happens to improve masking, and what would really be great is if President Trump would say I made a mistake. And I recognize, and I ask the entire country to start masking now. I think that would be just such an important move on his part. And maybe he will actually see that as being important to him to do that.
>> Howard Bauchner: I mean, we're still at 45,000 cases, 500 to 1,000 deaths a day, and we're beginning to go into the winter months. And I think people are increasingly concerned about that. This is Howard Bauchner, editor-in-chief. And it's rare that I actually get to interview legends, and I have today. But I do have one final question. What was it like to receive the Presidential Medal of Honor from President Obama? What was it like, Bill?
>> William Foege: You know, it's so humbling, because you realize you shouldn't be there. And so, it's hard to enjoy it as much as you should. But I tell you that one of the things that I appreciated about it, one of the people getting an honor was a man by the name of Gordon Hirabayashi. And I worked for a short period of time in Nigeria with a young man by the name of Jim Hirabayashi. And coming back to the States, I was reading up on the internment of Japanese Americans during the second world war, and I found out that one of the key legal precedents was from a case that was the US versus Hirabayashi. And so, I got a phone number for Jim that night and called him. And I said, "I've been reading this, is this someone in your family?" And he said, "That's my older brother." He was going to the University of Washington. And when they rounded up Japanese Americans to put them in camps, he refused to go. And so, he was arrested and put in jail in Seattle. But he would not give up. He said, "You have to have a reason to arrest me. It can't be just because I'm Japanese American." And his case went to the Supreme Court, and he lost the Supreme Court unanimously. I mean, think of this. If you believe that the Supreme Court is really infallible, think of that decision, and it was unanimous. And to his credit, he then was told to go to camp, but that there was no money to send him because they'd already sent the buses to camp. Gordon Hirabayashi hitchhiked to the camp and turned himself in. And now I'm calling his brother. And his brother said he is still so angry about what the United States did that he's living in Canada, and he teaches in Canada. But he said, "It so happens he's visiting me tonight, would you like to talk to him?" So I talked to Gordon Hirabayashi, and asked him, what will overturn this? And he could not think of a reason. He said maybe if a black panther is arrested for no reason other than being a black panther. Maybe that becomes the case, then it reverses, but he said, I can't see it being reversed. Well, as you know, it was reversed. And at point then, the University of Washington gave degrees to every Japanese American student that had been taken to camp and were still alive. And I was so pleased because Gordon Hirabayashi would now see that the country and this university had done right, only to find that he had Alzheimer's. And so he didn't even appreciate what had happened. But here he was, posthumously getting the Medal of Freedom. And so, I was so pleased that I would at least see Jim, his brother, and the rest of the family. And I get there only to find out that Jim had died the week before. And so, that was one of the high points for me is the fact that Gordon got the Medal of Freedom. Now the other thing, of course, was Bob Dylan being there. And I'm sure that that's the only reason my granddaughter went, [laughs] two granddaughters, they wanted to see Bob Dylan. And so, and John Glenn was also there. And just a medical note, I asked him what had happened about his MÈniËre's syndrome.
>> William Foege: And he looks surprised, and he said, "I didn't think anyone would ever remember that." But he said, it turned out not to be what they thought. He said, "I fell in the bathtub and cracked a bone," and that he'd fully recovered. But so that's a little medical tidbit on the side.
>> Howard Bauchner: Well, I know when you were introduced, it was interesting because President Obama made a joke about how tall you are. And he didn't often joke that much. So it was just interesting, because he was very struck about how tall are you. How tall are you, Bill?
>> William Foege: Well, now or used to be?
>> Howard Bauchner: Let's do used to be.
>> William Foege: I used to be used to be 6'7". I've lost about an inch. But I tell you, President Obama could not have been more gracious. Afterwards, when he met with the families, I had a granddaughter who was usually so precarious, and she was struck dumb. And so, I said to President Obama, "I know what she was going to say to you. She was going to tell you that on her birthday, she woke up and said today is my birthday, and it's also President Obama's birthday." And with that, he got down on his knees, and he talked to her face-to-face, and brought her out of that star struck moment. And I thought that was so gracious of him.
>> Howard Bauchner: This is Howard Bauchner, editor-in-chief of JAMA. I've spent the last half hour or so talking to a wonderful individual, Bill Foege, who along with Helene Gayle is responsible for the National Academy of Medicines report just released earlier today, Framework for Equitable Allocation of COVID-19 Vaccine. Bill, thank you for joining me today and please stay healthy.
>> William Foege: Thank you for having me. This was enjoyable.
>> Howard Bauchner: Take care, Bill.
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