3 10 229 Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound My role was to mobilize our partners. The partners who I work with are the women, the youth, and the traditional leaders. Our main focus was with traditional leaders. My role as head of the Carter Center team was to help work along with other partners to design specific interventions, and what we were focused on from our side, as the Carter Center team, was to use our platform. Over the years, we've been able to work with traditional leaders to build confidence, trust and confidence, and that's what we used during Ebola because if you see from the start of the outbreak, there were issues of trust. Citizens did not trust the government and so they refused to listen to messages from the government, even though they knew that people from their community were infected, people were dying, but they refused to accept the message from the government that something was wrong. That's because over the years there's been a big gap of trust between the governed and those that had authority. We over the years have worked with the chiefs. We've worked with them by telling them the truth--we've been able to bring information to them. We've been able to live up to when we made promises to them. So that trust helped us to engage. I brought that to the table at the level of decision makers when we went to these many sessions that took many, many days to decide what to do, why people were dying. We were simply just trying to tell them, this is the target group; these are the people we should work with. Instead of coming and spending one week to develop messages, go and tell the messages--before you can release the message, people are dying. Let's reach out to the people, because then it was easier to know that all of the don'ts about what helps to spread Ebola were targeted at actual traditional practices. We were working with traditional people, so we said, the easier thing to do is to bring these people on board--they can help us if they understand what is happening. At first they were resistant because people wanted to bring in experts. It was good to bring the experts to talk about how you can manage, because this is strange to this region, it's strange to this country. Experts were needed, but you also needed the local expertise. That's what we were providing […] Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Flomoku Trust Transcript Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound [T]hat was the start of the Big Idea of the Week campaign. What we realized was a dead body was a lot more infectious than somebody with Ebola because, as you can imagine, the dead body was teeming with virus. I remember when we were trying to put together a message that would resonate. Jenni and some of the others were like, I wonder if we can get this to be a pledge? I was like, I think we should think about that. And so I started writing it down and trying to make it understandable to the public. I remember that evening, I went up to my mom and I was talking to her, and she was saying, "What are you guys going to do about this Ebola outbreak?" I said, "Well, we have to provide the information for people to understand that Ebola is a terrible disease. What it does, it infects people who you love. What it does is it infects people who have compassion for you." We have a word for that in Sierra Leone, it's called ajo. "People who have compassion for you are the people who get infected with Ebola. Because they come, they touch you, they try to help, and then they get infected." And she was like, "Oh! That's a terrible disease!" I said, "Yes." So, I was just joking with her. It started off as a joke. I said, "I'm working on this, and I've been trained, and I don't think I'm going to get infected. But just in case, don't come near me." And she's like, "You like talking nonsense!" [laughter] And I'm like, "No, but it's true. It's true." I left from my mother's house and I went to the radio station with Joe Abbas. We sat there and we were talking about this, and he said, "Tell me a little bit more about this. Why is it important for us not to touch dead bodies?" I explained that by the time the person dies, the body is teeming with virus. Because of our traditional practices, or caring for the dead--washing the dead, grooming the dead, presenting the dead to the rest of the family and people touching, kissing, and all that kind of stuff--it provided an opportunity for the virus to jump from that dead person into the people he loved. I said, "I was talking to my mom, and I told her." I said it in Krio, and I'll try to do it here. I don't know if I'll be able to get the exact words that I said, because it just came out that way. But I said something like this. "So ar tell me mama, say--lek how ar dey wok pan dis ting so if me die, if me die mek ee no cam dey. If ar die ar no wan mek none me fambul dem touch me bodi. Because de ting wey go mona me pass all pass de die wey ar don die, nar if ar lay don nar me grave ar know say me infect me compin people dem wit Ebola." And in English, that would be something like, "If I die, I want my family to know that they should not touch my body. They should call"--I don't remember what the number was. Again, the numbers are different. "They should call the Ebola hotline and report my death, and let the dead body management team people come and take my body away and bury it safely. Because the last thing I want is for me to be responsible for infecting my loved ones." That took off in a major way. It was covered all across the world. The ministers and some of the other permanent members of the Sierra Leone community also made similar pledges. People started realizing--because this is something that's sacred. We all grow up--I mean, the last respect and honor you can give to your parents or your loved ones is a good funeral. For prominent people to come up and actually say, "If I die, do not touch my body. Call the response team, for them to come and get my body and give me a safe and dignified burial"--I think it was a very powerful message, and one that resonated across the country. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Williams Pledge Transcript Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound Safe burials was another one as well. There was a lot of death taking place at that time. They were working to enhance and increase their ability to respond and pick up bodies, but a lot of people lost a loved one and had the body there for days. With the cultural practice, at least in Muslim culture, when somebody dies, if it's a female, the female family members wash the body. If it's a male, the male family members wash the body. Here are these people that are going against their religious and cultural practices of mourning and grief and handling the dead. Because in some cultures, the way that you're handled after death, it's almost like that's how you're--it can be perceived that that's--someone has a responsibility to make sure you get to heaven in the best way. And we were asking people, "Don't touch them, don't wash them, don't do these things that you've been taught that it's the word of God that you should do this," and then we're also leaving you with the agony of having a family member that's no longer alive, present for days. That was really hard as well. Transmission from a dead body, from what I understand, the quote-unquote "amount of Ebola" that is in your body or the ability to be transmitted is heightened from a dead body. And people wanted to take care of their dead. They wanted to make sure that someone died with dignity. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Nur Dignity Transcript Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound I also knew that I would be implementing the Ebola Big Idea of the Week. It was basically taking these messages that were preexisting, and then making modifications based on current need. If they saw that there were challenges around burial practices and safe burials, that maybe this one week's message was around that. There was a really integrated approach of it being a radio, the radio messages, they could be crafted for newsprint, they could be crafted for healthcare workers, if people wanted to do interviews--it was really for journalists to be able to take this and use it as a guide to develop how they were going to communicate about Ebola that week. I was lucky in that the person that was there left me with I think two or three weeks' worth of content. But then I was asked to develop the next four to six weeks of content. It was a good experience, but it was a little challenging because there's a cultural element to it, right? I need to know what's happening. They have different holidays or cultural celebrations or national celebrations that take place, and making sure that what we're encouraging people to do, like trying to discourage mass gatherings for a national--Independence Day. That's not the example, but for the sake of this conversation, an Independence Day celebration, and reinforcing the health precautions around mass gatherings and things. So, yeah. There was a lot that I learned while I was there. There was a whole conversation about infection prevention as it relates to chlorine and the right mixture for handwashing versus cleaning. I don't know. But you learn who your points of contact are and who you can work with, and you really have to stay on your toes. I remember somebody said that when you deploy, you might go over thinking that you're going to make bread, and you end up having to fix cars. You just have to be prepared for whatever you're asked to do. It should be skills-based, but you may get on-the-job training. I hadn't had a lot of field epi, but I was working with people that I could learn what they wanted me to do for case investigation […] Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Nur Communication Transcript Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound JERNIGAN: "[M]essage of the week" things, or "big idea of the week," I can't remember the--big idea--<o:p></o:p> Q: Big idea of the week, I think, yeah.<o:p></o:p> JERNIGAN: --that, rather than say, "Hey, let's build some communication messages," and then that's what we use for the response, they recognize that people quit looking at things. If you change it each week and coordinate it across posters, videos, YouTube, TV, broadcast, radio, whatever, and push that even down to the community monitors and others, then you have a coordinated weekly message to pregnant women, or to the elderly, or to kids, focused on soccer or whatever. Those were critical, I think, for making sure that people were constantly being reminded of the potential for infection and what to do if you got sick, but also such that if you did get sick, if you heard a survivor on TV or whatever, you're more likely to do something than not. Because if a survivor said, "I'm fine, it was okay, they didn't poison me with the food," which there was so many rumors going around. Social mobilization was key.<o:p></o:p> Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Jernigan Communication Transcript Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound Dealing with distrust was I think the most difficult thing. I told you last time about the whole chlorine. When I was in Bo doing social mobilization, we went to different villages, and Bo was just getting new cases--neighboring Kenema. Kenema, height of the epidemic in July, they were getting controlled. It died down, but then Bo was starting to get new cases and they were getting really scared why we get pockets of cases, where did they come from? We would go out to the villages and ask the chief what happened and why does the chief think it happened. The entire village came close to our car, very upset, very hostile, telling us to leave the chlorine bottle next to the car if we were to walk into the village. We were really confused, and we don't want to go anywhere without chlorine because chlorine is my lifesaver. So we had a local who spoke Mende ask, "What's going on, why is chlorine bad?" And the chief started explaining, "We had a community clinic. A lot of the nurses died, and then a bunch of white-clothed people came in, started spraying inside the clinic. They closed the door, they locked the door, and the spray team said don't go inside." Without telling them when they could go back inside. So the chief thought, oh, it must be really toxic and that's why they told us not to go inside. So, one bad memory. And then when there were other sick people, he called an ambulance. The ambulance team takes the sick person, puts them in the ambulance, closes it and starts spraying outside the ambulance. They thought, oh, there's no ventilation inside and the fume is really toxic, so they're killing the person. Let alone all those sick people never came back, so what's the point of notifying that they have a sick person? We had to explain to them that it's our bad that we didn't tell you when you can go inside. Chlorine kills Ebola virus, but we just want to make sure that it kills Ebola virus completely before you go in and accidentally be exposed to the virus. That's probably why these people told you not to go inside. But we love chlorine--not chlorine itself, but the chlorine solution because I feel really safe, especially in a country where we don't have running water. We demonstrated in front of them, sprayed it on our hands, our boots, all over, and nothing happens, right? So the chief felt comfortable demonstrating the same thing in front of the village members. Village members looked like they were getting, okay, maybe it's okay, and they were starting to talk to us and listen to what we had to say and things like that. It was an eye-opening experience to understand what kind of communication barriers were occurring. Now we needed to move forward with that, chlorine is safe--like we have to incorporate that now. Those kinds of things, you would never know sitting in a room, unless the locals understand that nitty-gritty to tell us. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Lee Distrust Transcript Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound Q: Let's dig into that. What were some of those challenges that happened at launch?<o:p></o:p> SEWARD: We were hoping to launch before the end of March, and so March 31st we were hoping to actually get started, and that's what we'd planned for. We had a meeting with the minister of health right before we launched, and I attended that meeting. I think Oliver attended, Dr. Samai attended from the College of Medicine. At that meeting, some new concerns were raised that we hadn't heard about and that we had to then scramble to try to figure out how to address them, The minister had concerns about liability insurance and wanted a guarantee of fifteen to twenty years of liability insurance for the trial, which is unheard of. Nobody does that kind of liability insurance. We had a policy in place, and Merck did as well. There were a lot of phone calls with CDC and with Merck to see if we could increase our insurance, at least commit to the five-year tail of insurance period after the trial finished. We had insurance in place for the trial, both global liability insurance and local liability insurance, and then CDC ended up committing to an extra five years, which you purchase at the end of the study period, generally, and you generally only purchase that if there's anticipated to be a problem, or if there's been a problem. You don't usually go ahead and purchase that if you don't anticipate a problem. We committed up front to purchasing that for an extra five years, and that was quite a financial commitment, for an extra ten million dollars of insurance for five more years, and so that took some time to get that worked out.<o:p></o:p> The minister also had questions about vaccine availability after licensure. Assuming this vaccine were to be proved safe and effective, what would be the availability of the vaccine to the population of Sierra Leone? That was a very valid question, but in fact, people from his ministry had attended meetings at WHO on that very issue. There had been a commitment by GAVI, the Global Alliance for Vaccines and Immunization, to purchase vaccine for some of these countries if and when a vaccine were licensed.<o:p></o:p> The third issue that came up suddenly was about a renal dialysis unit. This was quite unexpected. We had been asked previously to help get an intensive care <a href="https://globalhealthchronicles.org/ohms-viewer/viewer.php?cachefile=JaneSeward.xml" data-timestamp="55" data-chunksize="1"></a>unit up to basic international standards at the main city hospital in Freetown, a hospital called Connaught Hospital, and CDC doesn't work in clinical care, so we had to work through partners to help get that done. We worked with King's College and DFID [Department for International Development], the UK [United Kingdom] aid organization, offered to help with that. DFID helped get some equipment and some training for staff in the intensive care unit, but that all hadn't been completed when we were ready to launch. It was all in progress but hadn't quite finished. The renal dialysis unit had never come up, so that was a completely new thing. "As well as the intensive care unit, we want the renal dialysis unit functioning and at international standards." Well, the renal dialysis unit was not being used. They in fact had one, but it was not functional, and you don't want to use it during an Ebola epidemic. They were doing hemodialysis, which involves blood going through tubes and is quite a dangerous procedure in any country. It has to be done under very, very good infection control. We then had to have a lot of discussions about what to do about that demand, because the minister made it a condition of launching the trial. I spent a lot of time on the telephone, I spent a lot of time summarizing meetings in-country, sending them here to Atlanta to Dr. Schuchat and Marc-Alain and leaders for STRIVE, Dr. Schuchat being the overall senior leader for STRIVE since the very beginning. That's been very useful to have that continuity and institutional knowledge at a high level. I mean, I knew which decisions needed to be made here. I was not in a position to make them, and so would have conference calls with Anne and Marc-Alain and people and say, "What do we do know?" Talk with Oliver at that end, and had further discussions with the vice minister of health.<o:p></o:p> I was thinking recently, actually, because it was Easter recently. Easter there is a four-day holiday, and that was early April last year, so it was while we were in this limbo period of trying to get the intensive care unit ready. She--the vice minister--was helping with that, and I spent time sitting under a tree at Connaught Hospital in the heat talking to her during the Easter break, when there was nobody to work there. She wanted the walls painted. She wanted the place to look better. She thought that would help with this final review by the minister, and so she was trying to get those things done, and I was just down there. I couldn't do it, but I thought I would try to see what I could do to help. So spent some time sitting there with the vice minister, getting to know her, as she tried to push to get the intensive care unit ready. Meeting with King's College, talking to them, could they accelerate getting the--the equipment had been delivered, but hadn't been put into the intensive care unit yet. Had to go through all sorts of regulatory review at the hospital, to be sure that it was all documented which equipment had come in, so that it doesn't go missing and things like that. Then they had to do the training. Turns out they didn't have, what's it called--equipment that you use to start the heart.<o:p></o:p> Q: A defibrillator?<o:p></o:p> SEWARD: Yes. Didn't have a defibrillator, and they wanted a new one, and so we borrowed one from the embassy. We borrowed an extra one that the US embassy had and delivered that to the intensive care unit. We patched together what we could for that. We came up with an acceptable compromise on the renal dialysis unit of offering some funding to help support purchasing equipment, although in the end we couldn't purchase equipment. We couldn't do it through CDC, and through appropriated dollars the CDC Foundation couldn't do it either, and so we committed to helping with consultancies if they had need for technical assistance to try to get the unit together. Then we would try to find partners to help with that, if needed. We had that letter signed and submitted to the minister. With that letter that Oliver signed and Anne signed from here, and the intensive care unit painted and the equipment in there and the training done, an extra ten million dollars from CDC for the liability insurance tail, and extra insurance also from Merck. We started with thirty-two million dollars of insurance, liability insurance, during the trial itself, and then $12 million will continue in the five years afterwards. With all those in place, we sat down again with the minister. In the interim there'd been a meeting with the president, so the minister requested a meeting with the president, so I went to that with Oliver. The ambassador's--the deputy, DCM [deputy chief of mission], the deputy person in country. The ambassador was out of the country. She attended, and was very experienced in negotiations, actually. She was great.<o:p></o:p> We attended that meeting with the president himself, and he essentially said, "You need to pick a date to start and work back from there to get these things done." He essentially gave a marching order that we should start, and I don't remember whether it was an exact date, but he did sort of say, "Thursday next week."<o:p></o:p> Easter came. It was right in that period, and so not a lot happened over that, and then Tuesday, Wednesday, the vice minister came back to Connaught Hospital. Things weren't quite ready. We were thinking, who's going to give us the green light here? We didn't have a green light, so each day we were sort of like, do we call the staff in? Do we not? Do we have to give them some warning to show up for the first vaccination site? They were being delayed. Finally, I think I was told to be down at Connaught Hospital for a final walkthrough by the minister, and then got a request that no, he wasn't coming there, we needed to go to his office. So, Oliver, the ambassador, who was back, and me attended a meeting with the minister, and actually the ambassador was extremely helpful in that meeting, in getting the trial started. The meeting went for an hour and a half, and in the end the ambassador suggested, he said, "What about if we start tomorrow? These other things are in progress, and let's just start and we'll keep meeting for following up on these issues." The minister said yes to that. We knew at like eight o'clock the night before we launched that we had a green light to launch the next day.<o:p></o:p> It was a challenging time. [laughs] It was really challenging. When I think back, I think at this end it was probably harder. It was probably easier to be there and experiencing it. But it was, yes, it was a very big deal. Exactly a year ago. It was April 9th that we launched, and we started the next day. Once we got started, it was very hard to stop. It was a very good suggestion of John Hoover's. We were waiting for the minister to say okay, but he didn't say it in this meeting. John, having more experience at a high level with negotiating, I think it was a very good suggestion on his part. "Why don't we just go ahead and start? Everything looks like it's okay, and then we'll just continue."<o:p></o:p> There was overwhelming demand and interest in the vaccine, and so I think there was a fair amount of media coverage and interest. I think it would have been challenging for the minister to stop things, once they started, provided there was no reason to stop, which there wasn't, fortunately. Once we started, that was it.<o:p></o:p> Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Seward Challenges Transcript Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound CALLIS: It was such a dynamic time, things were changing daily, that you just never really knew what the day was going to look like. We hadn't launched yet, we were really working hard to get--I mean, a clinical trial can take years of planning. We were working really hard to get all of the pieces in place from even the buildings. We had to refurbish some buildings. It was logistically a really heavy lift. It took us a long time to get it off the ground and actually launch. Prior to that, from a communications and social mobilization standpoint, Sierra Leone had never seen a [vaccine] clinical trial. Nobody had ever done one. We were in the midst of a horrific emergency. We needed to be able to talk to the potential participants in a way that gave them the information so they could make an informed decision, but didn't promise. People were so desperate for a solution. We wanted to really be clear, this was a trial, we didn't know. We had a good sense that it would probably work [but] we didn't know. We didn't want to hold out hope in the middle of this emergency, and so it was a delicate--it was a bit of a tightrope, trying to talk to people about the trial and their participation in it. Q: Can you talk more about, so what that communication work really entailed in the beginning? CALLIS: Before I came, there were folks who literally mapped out every single hospital, every single Ebola treatment unit, every single Ebola holding unit, everything, so that we knew where all of the potential participants were. The trial was only open to healthcare workers and frontline workers, burial workers, people who swabbed out the ambulances, things like that, and the reason why was because they were at highest risk. They were dying by the numbers. I remember when I got to Sierra Leone in February, I went to Connaught Hospital, and I had been there years before, and when I walked in, every wall was plastered with obituaries. Photos of all the nurses and doctors who had died, and it really hit me. I think there's a great responsibility that comes with that. This country had a fragile healthcare system to begin with. And then they lost so many of their best and brightest. And we, I felt a deep responsibility to both honor the risk that these people were taking, but also make sure that we provided them all the right facts, so that they could really decide if they wanted to participate or not. Once we had done this enumeration of all of those hospitals and everything, we literally went to every single hospital and we sat down and gave an information session where we talked about everything from the science that had come before this trial, what we knew, what they could expect, what we felt that some of the side effects would be. All of these things. After, we opened it up to questions, and everybody was able to ask their questions and everything. We did this in hundreds of places. And probably talked to, unfortunately we don't have great records, but I would guess that it was upwards of one thousand to two thousand at least. Then, if they decided they wanted to participate, when they came to the actual vaccination center, we again did a smaller information session and allowed them to ask questions. Then they did an informed consent one-on-one where they would sit down with someone who spoke Krio or Temne, or whatever it was that their native language was. Often cases, it was English. They would go through the informed consent step by step by step, and allow them to ask any additional questions at that point. It was a very high touch and in-depth process, but from an ethical standpoint, I feel very strongly that we did it exactly the way it should have been done. Q: What makes you think that? CALLIS: Well, we--first of all, the response was amazing. We never had backlash, we never had any big rumors or backlash against the trial. I think a lot of that was due to the fact that we one, worked so hard to provide the right information to the participants. But we also worked with the community. I sat down with chiefs in the area that we were working in, and would sit and talk with them, and I would go back every six weeks, or part of my team would go back every six weeks and update them and the mayors and the city council and hospital administrators. We really made it a priority to continually communicate with these people and make sure that they felt a part of this process, and that they could talk to us if they had concerns. Because we knew that they were people that the community was going to talk to, and say hey, we heard about this vaccine, what's going on? I think that was really important. It's ethical, it's respectful when you're in a country to sit down and talk with the stakeholders and the leaders. But it also helped our trial. We had hoped to enroll six thousand people--we enrolled over [eight] thousand. There was a lot of support for this. A lot of hopes hung on it. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Callis Communication Transcript Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound SCHUCHAT: From that weekend on was an evolution or a journey of thinking about how to try to test a future Ebola vaccine in the middle of an epidemic in a place that had never--that had not got a vaccine field site going. The next several months were--we can go into however much detail as you want, but developing, recruiting a couple people to work on this fulltime, to develop it out. Then many changes in our design and plans. Q: What are some of the most important of those changes of those decisions? SCHUCHAT: We initially proposed a stepped wedge approach. You may, you probably heard. There was a lot of discussion about, can you test--a randomized controlled trial is a pretty hard thing to pull off. Double-blind, large numbers, everybody involved needs to--you have to follow incredible protocol, details, of course. But also the idea of placebo and blinding is pretty complicated when you're--even just an investigational vaccine is pretty complicated. We thought, well maybe we could do a stepped wedge design which would be a way that everybody's eventually going to get it, but they don't all get it on the same day. You use the observation time before you get it of what's going on, but it takes a huge population and you actually have to get everything ready to go in terms of enrolling the whole population and tracking disease in them before you start giving vaccine, or there's problems. We started off with that plan and we started developing sample size calculations doing the paper version of the protocol. Then October 23rd, 2014, there was a meeting at WHO [World Health Organization in Geneva] about vaccine trials. I went for CDC and there were folks there from NIH and there were folks there from a number of academic institutions. Then there were people from the [affected] countries, as well as a number of donors. We were talking about what could be done. There were manufacturers there about their candidate vaccines. Where are we? Because frankly, we were talking about stuff but [products] hadn't really gone into people very much at all at that point. That usually takes--it takes multiple years [to go] from animal [trials] to people for the small studies in people, and we were talking about doing a big field trial. October 23rd was the first time that we offered. [CDC] had folks in West Africa already for the emergency response, but at that [Geneva] meeting we started to talk about this idea and if Sierra Leone was interested, or others were interested, we would be interested in working with somebody on this. Then the next week, or the last week in October or first week in November, we sent three people from CDC Atlanta to Sierra Leone to start meeting with counterparts and start talking about possible studies. Initially the possible study was this stepped wedge design. The folks--you'll probably talk to different people. People who went to the field in November and December--I'd made my first trip early December and by then we had a lead from the Sierra Leone College of Medicine and Allied Health Sciences, our principal investigator. We had a lead from the Ministry. They had been doing a lot of outreach to try to understand what was important to people. If we were going to do a study, what needed to be considered? They were looking for possible sites, trying to figure out where would we do it, trying to match what was going on with the epidemiology with the logistic needs that we have. December, early December, it was still quite hypothetical, but it was still quite urgent. I think the week I was there was actually, looking back, the peak week of disease in terms of the number of cases per week and so forth. An overarching principle for us was not to distract from the response. CDC's staffing really had to go for emergency response. Staffing for our trial team couldn't take people who were going to be working on the response. We needed a lot of different kinds of people, but we had to make sure. It was kind of exciting to work on a vaccine trial, but [we couldn't reassign people], no, no. You've got to fill the spots in the response [first] and then we can get people, although we needed people with certain skills. In any case. In December, we were having leads here in Atlanta for the design, or for the trial which at that time was a planning [activity], and leads in the field who were figuring out [logistics like] who were the counterparts, where might we do it, what's all involved in this? Just to jump ahead. I think we've had over three hundred CDC staff involved in this trial, because people were rotating through both in the field and in Atlanta. I may be the only person who's been involved since September [2014]. We changed the design, we had to select a vaccine, we had to identify who would be eligible, we had to develop a cold chain. We had to do this in a way that would be acceptable and that would be, have both short-term and long-term acceptability. Our leads in the field from Sierra Leone, as they went out talking about this project, learned that when you talk about an Ebola vaccine people think you're talking about a vaccine that gives you Ebola. We learned that CDC didn't necessarily have a good reputation in Sierra Leone before the Ebola outbreak and that there were concerns that that field station CDC had in the eighties might have been where Ebola came from. It was really important to us that there be country ownership and a country voice and face for the trial, and that CDC work on this in a collaboration. My first trip in December, our lead from the university, we had a really good discussion and he said that the most important things from his perspective were transparency and mutual respect. I said, perfect, because those are really important to me, too. We had multiple objectives. Our overarching objective was to accelerate use of a vaccine while simultaneously evaluating its safety and efficacy. We didn't want to [roll out] vaccine that was unsafe. We wanted to find out if it worked quickly, because it if it worked quickly it would be important to scale it up. We didn't want to just answer a study question and then stop. In Liberia, their goal was really good science of randomized, controlled, placebo-controlled safety and immunogenicity of two different vaccines against placebo. They didn't really have the phased introduction idea. In our study, we didn't stop when we realized we're not going to be able to measure efficacy because part of [our purpose] was accelerating availability and we were targeting high-risk healthcare workers and frontline workers. We ended up pretty much vaccinating anybody in the five districts we targeted who met the criteria, who could be enrolled. Essentially, [health workers in] those districts pretty much were eligible. We got over eight thousand people vaccinated with what I think is probably a very effective vaccine. The vaccine's [still] not licensed. It's 2016. As there are new cases and we do outbreak response, [vaccine] still [has to be used] under a research protocol [in order for] people to get vaccinated in the rings. We had from the beginning that goal of quickly figuring out if [the vaccine] works or if it's harmful while [if it's not harmful] making it available as quickly as possible. The second overarching goal was to strengthen the capacity of Sierra Leone. We wanted to do this trial in a way that not only was safe, ethical, scientifically rigorous, but that had a long-term benefit for the country even if the vaccine didn't work, or even if the vaccine was harmful. I think it's really hard in 2016 to fully remember or understand that this was a pretty scary enterprise. In December of 2014, a little study in Switzerland found unexpected side effects of one of the two vaccines. We had to decide which of these two vaccines are we going to use. We said, one of them has a better [chance]--we think theoretically it might be more effective. We didn't know. Just based on the nonhuman primate [results] and the immunogenicity, you couldn't really tell. We think the one that might be more effective is the one that might have unexpected side effects. We're talking about a community that has--is dealing with an epidemic, has very limited healthcare, all those things. We had to go through all this expert review to figure out which of the two vaccines to propose. Then we needed the country to decide, what do they think? They agreed with us and we went with the one vaccine [vesicular stomatitis virus, VSV]. The first doses [were given] when Jane [Seward] was there--that was intense. In January of 2015, we got the first dose response results from the human immunogenicity studies done elsewhere and instead of this dose [that we had expected], we needed a higher dose. Instead of a dose we were expecting, we needed an even higher dose and that meant that the bottled formulations had to be diluted in the field in a different way. It's a live replicating vaccine. Just the quality control of dilution. The vaccine had to be kept at minus eighty degrees. We had to get that to happen in a place with a very--where the power--just to have power and a backup generator and everything was really complicated. We had to transport [vaccine doses] to all these different sites that we were going to be using. The logistics [reality] and the rigor [needed] were always in tension, just to make sure that we could do this carefully and well. Then we had an extraordinary communication plan, because it was really important to us that people voluntarily participate, that they understand we didn't know if this [product] worked or not, that they didn't put themselves at extra risk because they thought they were protected with the vaccine. One of the reasons we didn't use a placebo--we changed our design, but we didn't ever use a placebo--was our principal investigator felt like people won't believe if you just give them a shot, they're not going to believe it's not real. Whatever you tell them, they're not going to believe it. We counseled everybody on continuing to use protective equipment and so forth. Anyway. We had to pick the vaccine, we had to change the formulation plans and really try to do everything as safely as possible. Our communication program, the folks in Sierra Leone and our team from CDC really worked hard on stakeholder engagement, visiting the chiefs in the districts, visiting the health leaders in the districts, meeting with all the healthcare workers before they could enroll to really understand how we should design this in a way that was going to be acceptable. Then had to do the training, very short notice because it was a race against time to get the trial going. Both because we wanted it to be useful and because the cases were starting to go away, which was good. My role was--there was many funny things about this trial, but my role was cheerleader because almost every day additional problems emerged. The two leads in Atlanta would meet with me every day, tell me what they were hearing from the field, what was the latest catastrophe, and I would reflect what we ought to do or help give them feedback. Then I had these pom-poms and I would bring out my pom-poms to say, we're going to get through this. It looks like there's no way out of this, but we've gotten through worse before and we'll keep getting through it. I think nobody believed it was going to happen until it started and then when it started, of course, there were so many other additional challenges. Whenever we thought it was about to slow down, something else happened. It's been a big journey. Very, very meaningful to be part of […] Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Schuchat Vaccine Transcript Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Ebola - Oral History Transcripts Oral History A resource containing historical information obtained in interviews with persons having firsthand knowledge. Transcription Any written text transcribed from a sound As long as you have a coworker in the community, you must touch each other. We eat together, we used to play together, and at that time we were not being told that we should not be close to each other. We just went into the fight unknowingly to us. Even that chlorine administration that they came up with later, it was not introduced at first to us that we should use chlorine. We were not using chlorine. We don't even know about it. When we enter into the center, the epicenter, the dead zone area, we come out, we undress ourselves. There was nobody watching after us. We did everything by ourselves. That is how most of our colleagues got infected, during the undoing of the PPE [personal protective equipment]. Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Kallon Protocol Transcript