Dr. Jane Seward

Dr. Jane F. Seward

Q: This is Sam Robson, here today with Dr. Jane Seward. Today's date is April 14th, 2016, and we're in the audio recording studio here at CDC's [Centers for Disease Control and Prevention] Roybal Campus in Atlanta, Georgia. I'm interviewing Jane as part of the CDC Ebola [Response] Oral History Project. Jane, thank you so much for being here.

SEWARD: Great to be here. Thanks, Sam.

Q: Of course. For the record, could you please state your full name and your current position with CDC?

SEWARD: My full name is Jane Frances Seward, and my current position is senior advisor to STRIVE, which is the Sierra Leone Trial to Introduce a Vaccine against Ebola. I'm in the National Center for Immunization and Respiratory Diseases.

Q: Thank you. Can you tell me when and where you were born?

SEWARD: I was born in Australia, in Perth, Australia, in 1950.

Q: Is Australia where you grew up?

SEWARD: Yes, grew up in Australia, went to school there, went to medical school there, and then met my husband in Papua New Guinea, of all places, when I was a 00:01:00medical student. He was an American medical student. I ended up coming to the US to do my internship and residency after I graduated from medical school in Australia.

Q: Can you just talk about, leading up through secondary school? Which is secondary--is that high school?

SEWARD: Yes.

Q: Okay. [laughter] That's embarrassing. Up through high school. I just didn't know if there was an equivalent. Do you call it high school in Australia?

SEWARD: Yes.

Q: Cool. Up through that point, what were your interests?

SEWARD: I think general things that were of interest to most Australian kids at that time. I liked science. I liked languages, English. I was a good tennis player. I played a lot of tennis, did a lot of swimming. Everybody in Australia 00:02:00needs to learn how to swim. Sports were very big in Australia and at the school I went to. I was good at science and math, came pretty naturally to me, and so I then went to medical school after high school. Medical school in Australia is a six-year degree straight out of high school, and in Western Australia you graduate from high school when you're seventeen and you start college the year you turn eighteen. It's called "university" there, not college, and so I started medical school the year I turned eighteen. I was an MD [doctor of medicine], or an MBBS, bachelor of medicine and bachelor of surgery, by the time I was twenty-three, and I came to the [United] States to do my internship and I was a couple years younger than the medical students. [laughs] It was kind of interesting.

Q: Oh my gosh. Quickly, can you tell me--were you raised by your parents?

SEWARD: Yes.

Q: Okay. What do they do?

SEWARD: My father was a dentist and my mother was a social worker.

Q: Got you. Thank you. What prompted your move to the United States?

SEWARD: Meeting my husband, who was a medical student when I was a medical student in Papua New Guinea.

Q: Right. How did you get to Papua New Guinea?

SEWARD: Went up there with a friend, and was just travelling around for the summer, and was going to go and work in a hospital. Had set up to volunteer in a hospital, and then bumped into my husband at a Christmas party. He was there for a year as a medical student from Cornell [University] Medical School. They sent two or three students a year to an Institute of Human Biology that did research 00:04:00in the highlands of New Guinea. And so we met there, and got me very interested in public health and international health, that whole experience.

Q: No doubt. Were there specific experiences that you had there that are memorable to you?

SEWARD: I think just travelling around. My husband was working on a project following up children who had a condition called "pigbel." That's the Pidgin English name for the condition. It was pig belly. It was acute abdominal pain that resulted in surgery quite often, and a number of children died with this. They couldn't get to the hospital in time from where they lived, so oftentimes when they did get to the hospital and were operated on, they had a section of the bowel removed because it was gangrenous, and then they were sent back to 00:05:00live in their village with not a whole lot of follow-up. His project was to find all these kids from just having a name and a village name, perhaps, and probably a parent name. He had to drive all over the highlands of New Guinea to do this, and so that was pretty interesting.

Q: Was it hearing about that experience that got you interested in public health, or how did that--were you more medical before, and then--

SEWARD: No, I think I was--I think the interest in public health grew over the years. I did pediatrics as my residency and training, and I think a lot of pediatricians working with children realize it's better to prevent illness than to treat it. I think a large proportion of CDC's workforce, epidemiologists, are 00:06:00trained in pediatrics. I don't know if that's just a coincidence or what, but preventing illness at a community level seems better than treating it, so sort of got interested and decided to work in that field.

Q: Tell me about your first few years in the United States, residency.

SEWARD: My husband went to Cornell med [medical] school, and then did a residency there at Cornell, in New York City. I moved from Perth, which is a reasonably sized city, about the size of San Diego with a climate similar, to New York City, which was quite a change. I was applying as a foreign student, so I didn't have a great chance of getting a high match for residency. I did internship at a small little hospital in New York City, but it was a good hospital. What they lacked in experience they made up for by having you rotate 00:07:00into a large city hospital for a couple of months a year, to a big cancer hospital that was there, [Memorial] Sloan Kettering [Cancer Center] in New York City. That was a good experience. We then moved from New York to New Orleans and finished up peds [pediatrics] training at Tulane [University], at Charity Hospital there, at the big C, and got great experience with very underprivileged population there, in inner city New Orleans.

Q: What happened then?

SEWARD: After that, we finished our pediatric training. My husband, RJ, did his master of public health in tropical medicine while I was finishing my peds, and then we travelled for a year. We didn't work, so we drove to the West Coast and 00:08:00then drove up to Alaska and did hiking and canoeing and different things. We then went across the Pacific and ended up in Australia and spent some time there with my family, and were looking at work options as we went. In Perth, we talked to some people, and we ended up coming back there to work for a while. That kind of cemented getting into public health. One reason was our pediatric boards, which we had passed--so the peds training here wasn't recognized in Australia. We would have had to have started again with all the postgraduate training in pediatrics to pass their fellowship exam, which is different. Pediatrics in Australia was also a referral specialty program and general practitioners, GPs, took care of children. Pediatricians were people that you referred somebody to 00:09:00with an unusual problem in a child. It was quite a different kind of specialty. So it was just complicated to switch into clinical work there. We both did public health and then we liked it.

Q: When you say you did public health, what does that mean?

SEWARD: Well, RJ worked on a research project at the children's hospital in Perth [then the Princess Margaret Hospital for Children], and I worked for somebody in the state health department and at the University [of Western Australia]. So we were working in different areas, but we both then decided that we really wanted to pursue a career in that, and that we needed more training. There wasn't a master of public health program in Perth at that time, so we couldn't stay and do any more training there, and then a visiting pediatric 00:10:00geneticist who was visiting the children's hospital for a couple of months as a consultant on an exchange program told RJ, my husband, about the EIS [Epidemic Intelligence Service] program. He had gone through EIS, this person, and hadn't stayed in public health himself--he was still working in clinical genetics in Cleveland--but he said, "Oh boy, this would be a great program for you." So RJ applied for EIS. This was back in '79, and then they did interviews by phone. He didn't have to come here. Several interviews on the phone, and he got accepted. We then came to Atlanta, and while he [served as an EIS officer], I did a 00:11:00master's in public health at Emory [University] part-time. We had one child by then. Our first child was born in Perth, and then the second once we got to Atlanta, so I was doing part-time MPH and at home with the children.

Q: What are your kids' names?

SEWARD: Nicholas, Andrew, Jonathan, and Sam. I have four boys. The last two are twins. [laughs] Went for a third and got four.

Q: What did you think of Atlanta?

SEWARD: I think we wouldn't have moved here if CDC hadn't been here, to be frank. My husband grew up in Colorado and Utah, and really liked that part of the country. I did as well. I grew up on the coast and liked the coast, and Atlanta had neither of those things, but it seemed--I mean, CDC was certainly a place to come to, and so we came with an open mind and we've ended up staying here.

Q: Did you end up with a specific thesis for the MPH?

SEWARD: Yes, I did. I worked actually with somebody at CDC, so that was one way that I got to know people at CDC. I took part in a huge taskforce review of the literature about infant feeding and infant health. Back in the early eighties, there was a big to-do about formula feeding killing babies. There were signs, "Nestlé's Kills Babies." Because children that weren't being breast-fed in some of these developing countries and were buying formula instead couldn't afford it, didn't mix it up correctly. It was potentially a dangerous thing for parents 00:13:00to do, if they didn't know how to do it properly or couldn't afford to buy the milk at the necessary concentration, etcetera. I worked with a CDC supervisor to review all the literature about infant feeding and infant growth. There were other areas that were looked at, but that was our focus--the whole task force report was a supplement in pediatrics, and mine was one fifty-page article with hundreds of references. It was a great experience, and the person that I worked with, Mary Serdula, has stayed a lifelong friend. I was doing that project with two young children, a two-year-old and a baby. I would come meet with her with both the children with me. I did most of the work at home. I would come into the office as needed, but this was back at a time where the front of Clifton, you 00:14:00could drive into it and park your car and walk in the front door and go to the credit union, or meet with people. It was completely different than it is now. Completely different. You could literally just drive into Building One--that's gone now--and park in the front loop and walk in. Now, it's an active conquest to get in here.

It was a very good experience, that research project. Mary is in the nutrition branch, and now I think it's the Division of Nutrition, Physical Activity, [and Obesity], and she's stayed in that field her whole career. Other people in the 00:15:00branch at the time were Helene [D.] Gayle, who was an EIS officer, she's now head of CARE in Atlanta; Jim [James S.] Marks, who was a center director. A lot of very good people that went on to have pretty illustrious careers at CDC and after CDC.

Q: Yeah, it sounds like an amazing group of people.

SEWARD: Yeah, it was a very good experience, that project that ended up my so-called thesis. You had to either write a thesis or publish a scientific article, and I did the latter.

Q: Did they influence your thinking?

SEWARD: No. No, I mean, Mary and I just discussed all the papers and what they meant and how to put together what--I look back at that article now and I think, wow, that was kind of impressive to get that done as a student. It's a pretty 00:16:00big article. I think I'm pretty good at writing, but I didn't have a lot of experience at that time, and Mary was tremendously helpful in providing guidance. I was first author on the paper. It was very good mentorship by her.

Q: What happens after public health school?

SEWARD: After that, I was asked to teach in the Emory school of public health, [the Master in Community (or Public) Health program]. After I got my degree, I was asked to teach part-time in the Emory School of Public Health because the person who was teaching some of the core courses in epidemiology left for a sabbatical, and so I taught as adjunct faculty, part-time. This worked out quite 00:17:00well when my children were small. The teaching was sort of 5:00 to 7:00 pm kind of time. My husband could get home by then, or I could leave my children with a neighbor who was minding children. So, I did that. I taught the core course in epi [epidemiology] that was required for all MPH students, and taught a course in research protocol design. Then I did some part-time contract work in the Division of Nutrition, and again, that was at a time when it was--these were every small contracts, but they were working on issues with international health and nutrition and I could work flexible hours and things like that. I did that for a few years, and then in 1991, my husband had been working--has worked his 00:18:00whole career here at CDC in birth defects, and he started working on a big project in China about prevention of neural tube defects, with Brian McCarthy.

China had a perinatal center, a WHO [World Health Organization] center for collaboration in perinatal health, and they were looking at causes of mortality in the first month and the first year. In northern China, a third of the infant deaths--for the first year, a third of them were due to these birth defects, which was incredibly high. It was one of the highest incidences recorded in the scientific literature. They were interested in preventing these defects. Around that same time, information became available about folic acid potentially being 00:19:00linked with neural tube defects. A deficiency in folic acid causing a neural tube defect. Spina bifida is the best known example of those defects, or anencephaly, where you're born with most of the brain not developed. He [RJ, my husband] was going back and forth to China a lot in the late eighties, and then China was interested in doing this huge intervention project, giving folic acid to a lot of pregnant women and seeing if it impacted birth defects, those birth defects. We actually moved to China for his work at CDC, so our whole family moved to China in '90, '91.

Q: How long were you there?

SEWARD: Five years.

Q: Five years?

SEWARD: Yes. We went for two, and then extended, and we were there for five 00:20:00years. Our children, some pretty formative years they spent there. It's meant a lot to them, I think. Their outlook on life and everything has been very impacted by that time there, and a lot of the travelling and other things that they got to do by being overseas.

Q; Tell my about your life in China.

SEWARD: We got there and I didn't work initially, just helping us all get settled in and things. We were living at Beijing Medical University, which is across--in the northwest part of Beijing. A lot of the universities are in that area. That was back at a time where, well, very uncommon to have a family with four children, so a family of six. Beijing Medical University said they would 00:21:00provide us accommodation. Well, they couldn't find an apartment big enough for us because nobody had more than one child there, and there wasn't yet a private market for apartments and accommodations in Beijing back then. Now there is, but there wasn't then, so it was incredibly difficult to find us somewhere to live. In the end, we stayed at the university, and they took six individual rooms that were rooms for visiting students or faculty that were like a single room and a tiny bathroom, off a hallway, and they put a door across the hallway, and that was our house. They turned one of the rooms into a kitchen, and again, finding 00:22:00things like a dishwasher--nobody used them. They certainly didn't have a big one. They did find one, a tiny little dishwasher. A refrigerator that was bigger than just a tiny one was challenging. The university were fabulous. They went to a lot of effort to try to get us somewhat of a reasonable place to live. Hot water was challenging. It wasn't provided all the time, it was only provided a couple of times a day. In several of those rooms, they installed a small water heater so that we could run a bath or have a hot shower at times that were not the times when the hot water came on. Each room had a balcony, so we had six 00:23:00balconies. The kids thought it was pretty fun. We used one room as a living room, one room as the kitchen, one room as a study, and then two children shared two different other rooms, and then my husband and I had one. That was how we lived. [laughter]

Q: How did you spend your time?

SEWARD: We sent our children to the international school in Beijing, initially. There wasn't a precedent for sending your children to Chinese schools. They wouldn't allow them to go to the local Chinese school, although they would have made exceptions for us there on the campus at Beijing University, but they didn't have any capacity to help your child get up to speed with the Chinese and things like that. So we initially sent our children to the international school. 00:24:00A bus picked them up there. They had about a half an hour drive to get to school and bring them home. There was another family who were at another university with a couple of children who also got picked up by that bus. So, helping the children settle into school, and us just getting to know where to buy things. Finding butter? It was a huge challenge. Chinese don't use it, at all. Milk they didn't use much either. You could buy fresh milk, but it was usually in little plastic pouches on the street, not refrigerated, so you had to get out there, buy it early in the morning, bring it back, cut all the pouches open , and pour them into something, put it in a refrigerator. Learning where to shop for--I mean, vegetables was easy, but other things that we needed. Initially, we didn't 00:25:00have that accommodation worked out. We were staying in a student dorm and eating at the local student cafeteria, which was an adjustment for our kids. I do a lot of Chinese and different cooking, and so they had been exposed to more than American cooking, but for some of them it was more challenging than others. They're sort of fussy eaters, and so didn't want to eat the couple of dishes that were served at these places, at the student cafeteria. They all got adjusted pretty well, but helping them all settle into school.

Me exploring Beijing, which I did a lot, on a bike--would just ride all over the city and get to know the city. It was, then, a great place to live and visit. 00:26:00Now, it's really grown a huge amount, and I think it wouldn't be as easy to get around on a bike as it was then. It was a very good time to be there, actually. Initially, I didn't work, and then as I got to know people, I got asked to work for the United Nations Development Program, UNDP, so that's who I started working with first. They needed somebody who wrote English to write up a big proposal for a big scientific project that was being funded by the United Nations Development Program, and in addition UNICEF and the World Bank came in later. It was a big program to iodize the salt in China. They had some problems 00:27:00with iodine deficiency in certain parts of the country. It had been a very big problem in some areas, and that's why we iodize salt, and people have forgotten why we iodize salt. Iodine deficiency leads to goiter and mental retardation in children, and so it was a pretty important project. I started working for UNDP, then ended up working for UNICEF as well, and a little bit for World Health Organization. That gave me a lot of exposure to international health and to the UN [United Nations], which was pretty helpful.

Q: I imagine down the line that really came in useful.

SEWARD: Yes, it did, it did. When I came to CDC, when we moved back in 1996, a 00:28:00lot of my contacts--I was looking for a full-time job at CDC by then, and when we'd been in China, it had been during the--there'd been a freeze on federal hiring. There hasn't been one for a while, but in the nineties, there was a freeze on federal hiring. You couldn't come in as an external person and get a job at CDC. Right when we came back, the freeze had just been lifted, so suddenly there was an ability again to hire externally. So I was fortunate. I applied to the EIS program and was told no, you're overqualified. [laughter] I had to come in as an employee, get a job. I came back in advance of us all 00:29:00coming back and interviewed around in different areas to see what was around and what I might be able to apply for, and then ended up getting offered a job at the National Immunization Program. When we came back from China in 1996, five years later, then I started work full-time at CDC then. I joined CDC quite late in my career, in a way, given the circuitous path that I took to get there, but when I did I brought in experience in international health and other things. Birth defects, I actually worked in Australia in a birth defects area for quite a while, so it was interesting. My husband worked on enteric, diarrheal diseases, I worked on birth defects. He ended up matching in EIS in birth defects, and has had a whole career in that, and I've ended up in infectious 00:30:00diseases and vaccines.

Q: Funny how that works out.

SEWARD: Yes. [laughter]

Q: Were you in immunizations for a few years, or how--

SEWARD: I've been in immunizations my whole career, since then.

Q: Whole career at CDC. Tell me about it.

SEWARD: I started in what was then the National Immunization Program. That doesn't exist anymore; that was one of the centers that was merged into the current National Center for Immunization and Respiratory Diseases in 2006. For ten years I worked in NIP, it was called. I was in the Child Vaccine-Preventable Disease Branch, and I was hired to work on chicken pox, which a vaccine had just been licensed and approved for routine use in children. In 1995 the vaccine was 00:31:00licensed, and then recommended in '96. I came at the very beginning of that time, was asked to work on that activity, which is what I did. I became, firstly, a varicella zoster virus expert, and then worked on monitoring the impact of that vaccine with a lot of other people both at CDC and in various parts of the country. Varicella, or chicken pox, wasn't a reportable disease then, like measles is and polio is, etcetera, so we couldn't use the passive reporting system to look at the impact of the vaccine program. We had to set up special active surveillance, which we did in three different parts of the country. In Philadelphia, in Texas, and in Antelope Valley near Los Angeles. We 00:32:00had population based active surveillance sites, and I was the project officer for that project. It was an interesting time.

Then I ended up becoming a team lead over a team for varicella and shingles, or herpes zoster, because the vaccine came along for that as well. That's the same virus. Stays in your body and comes out later as shingles. Then I was branch chief, actually, when NIP merged with parts of NCID [National Center for Infectious Diseases] to form this new center. Our whole branch was merged into a division, a new division in this new center, and it was the Division of Viral Diseases. That was a tough time for a lot of people, but I think I was very 00:33:00fortunate, and so were my branch. We merged with another whole branch and Larry Anderson, don't know if you've heard of Larry, but he had a very eminent career here. He now works at Emory, but he was the branch chief in a branch in the Division of Viral and Rickettsia Diseases in NCID, so they took our two branches. Larry was made the division director and I was made the deputy division director, and we merged into this new structure of a new division here.

Q: When did the merge happen?

SEWARD: Two thousand six. NIP was at Corporate Square, so we moved here to Clifton in 2006, and have been in that new structure since. All of NIP was 00:34:00absorbed into this Center for Immunization and Respiratory Diseases, along with other parts of CDC, of NCID, including all the labs that supported the vaccine program. We already had very close working relationships with the lab people at NCID, because they were our lab counterparts in our programs. I had worked with all of them, of course, measles and mumps and other areas as well that I was responsible for in the branch. I think for me, it wasn't--it was a transition and a new structure, but I think it went fairly smoothly for our division, and not necessarily for all. It was just a challenging time. Big change in 00:35:00leadership and head of the center, and all sorts of things. That's when Anne Schuchat became the center director. She was the new center director. Walt Orenstein had been the NIP director, but Walt had left and when this new center was formed, Anne Schuchat was named the center director.

Q: What kinds of things did you work on then?

SEWARD: In DVD [Division of Viral Diseases]?

Q: Yes.

SEWARD: Well, I pretty much brought my vaccine expertise. We were a whole branch working on just vaccine-preventable diseases. Larry's group brought some vaccine expertise and a lot of laboratory expertise, then a lot of expertise in the non-vaccine-preventable diseases. His group had been the SARS [severe acute respiratory syndrome] folks, who identified the SARS virus. That was done in his 00:36:00branch, and did all the epi studies related to it. There were a lot of important things like rotavirus that was just a vaccine, had been used and then taken off the market, and another vaccine was just being approved for licensure around the time that the divisions merged. Then respiratory syncytial virus was another--is another very important disease that doesn't have a vaccine, but there's one in development. Norovirus, Cytomegalovirus. There were a lot of other areas in the division that came in that didn't have vaccines for prevention yet. Some of them were developing them, some were not. MERS [Middle East respiratory syndrome] is the new [disease like] SARS that emerged out of the Middle East and was given that syndrome.

I mainly brought my vaccine expertise, especially in vaccine policy development 00:37:00and evaluation. I'd gained all that experience working in NIP, tweaking all the policy for varicella vaccine, which started with a one-dose policy and then became a two-dose routine policy for children. Working through policy issues with surveillance. You learn by doing. If that's one thing I've learned here at CDC, is that you learn by doing, and you learn by making mistakes and learning how to do things a different way and working with all sorts of different partners in state health departments, especially. They are a very, very important, critical partner for our domestic vaccine program. I also worked on other areas in the division--norovirus--or helped advocate for programs and 00:38:00provide scientific leadership in some of the non-vaccine-preventable areas as well, but I mainly brought my vaccine expertise to the partnership and Larry didn't have that particular set of skills. He had another very valuable set of skills. He's a real virologist, he's an epidemiologist, but he's very comfortable working in the lab, which I never was. It's been an interesting ten years working for the Division of Viral Diseases. I've really enjoyed it.

Q: No doubt. Any other developments that happen within that division for you, personally, leading up to Ebola?

SEWARD: Not really. I was thinking towards when I might retire from CDC, and do something else as well, or instead of working for CDC, but hadn't really--was 00:39:00thinking about that. At the time that Ebola hit, I had started those thoughts. Nothing was concrete, but I was a little bit more open, I think, to working--I initially volunteered for, just for a deployment for STRIVE, in the field for six to eight weeks. It ended up being closer to ten the first time, by the time I came back, because there was an advantage in me staying. Then it was clear as they were trying to manage STRIVE with rotations, like they managed most of the response, it's challenging. You really ideally need some continuity, and we'd 00:40:00provided some of that continuity here in Atlanta with people moving out, temporarily extending details and working a six-month detail, but that's hard for their programs.

Dr. Schuchat asked me if I would be prepared to move into working for STRIVE full-time, and I was in a position that I had been considering anyway retiring and moving on from DVD, so I thought about it. I really enjoyed the time I spent in the field, and was happy to then leave DVD, or free up my FTE [full-time equivalent position]. I felt bad tying up my FTE in an extended detail. That wasn't fair to the division. When I thought through, and thought, okay, if they 00:41:00can find me an FTE in NCIRD [National Center for Immunization and Respiratory Diseases] to work on STRIVE full-time, I'll do that and free up my DVD FTE so they can hire behind me. That's what I did.

I then moved out of--did an extended detail, worked for STRIVE when I was back here and then went back out to the field for another two months. I ended up doing three long details to Sierra Leone over about eight or nine months. I spent six months there last year, between the end of February and into November. Then I came back here, was working here on the Atlanta side, so the people that had been providing the continuity here in the leadership role had to move back to their other positions, couldn't continue that, understandably. They were 00:42:00looking here for some stability on the Atlanta side as well, and so I committed to that about a year ago, and I've been working on STRIVE full-time since then.

Q: That's great. I'm going to take a moment and look at the monitor over here, because this box just popped up and I have to [laughter] have to maintain it.

[break]

Q: We're back. Sorry about that little break. Thank you for that really good overview of your career, but also your STRIVE experience, because that gives us a cool outline on which we can go back and review things. Before you volunteered for your first deployment for STRIVE, had you any involvement in the trial?

SEWARD: No. I hadn't. They were rotating people through all the positions in the field, including the field lead, and it was a huge machinery, as it was in the 00:43:00EOC [Emergency Operations Center]. We were not sitting in the EOC, but we were a task force and we were pretty much finding our own people to staff up the vaccine team. It's a lot of work, keeping those rotations going. I was just one of a rotation, going down. Typically, they would have an orientation before you went down, and you would join some calls, regular calls, that were occurring between the Atlanta team and the field team to discuss progress towards getting the vaccine ready for launch, the trial ready for launch. I started reading the protocol. I started a week or two before I went down, and only started part-time. You get down there and it's--you can read a protocol and a 00:44:00two-hundred-page manual, which hadn't been finished yet, actually--all the standard operating procedures that had to be put together. That was a huge amount of work on the Atlanta side and the field side, putting all those detailed instructions together for how to do every specific role in the trial. I read what I could, participated in some calls, and there was a supervisor here, Marc-Alain Widdowson, who had been one of the leads here in Atlanta. Marc-Alain was very available and happy to chat, and happy to chat once I got down in the field as well. The team here provided some good support, but you pretty much landed there. You had a little bit of overlap with the person who you were 00:45:00replacing, which was very helpful. Danny [Daniel R.] Feikin was the person I was replacing as lead.

It was a pretty critical time for the trial. We had hoped to launch it earlier, but it was a lot of work to be able to even launch it by the end of March, which was the target date we were hoping to do the launch. I got down there in late February. There was still a lot to be done before we could get ready to launch. We had to train everybody, develop training materials for over three hundred staff. Over three hundred fifty staff, actually. That was a whole week of training. CDC is pretty good at training. There were other partners that we worked with, but we did the lion's share of putting together--my team, I mean. I 00:46:00didn't do much. It was my team. I was just coordinating, really. I had a very good team. Some of the people that had been regulars in the team--before I started, the team in Atlanta had been working hard to hire people into positions for STRIVE, to stay in the field for extended time periods. To have some core people in that field staff who would be able to provide some continuity on the ground. Several of them went down with me, on the same flight, and were starting, and I was helping them, then, get their position worked out in a more stable structure in the field. There was a large field team when I went down. 00:47:00There were thirty people just working on STRIVE.

Q: In the field.

SEWARD: In the field, thirty field staff, CDC people. One person from BARDA, the Biomedical [Advanced] Research and Development Authority, from HHS [US Department of Health and Human Services]. Two people there from BARDA, one helping with the cold chain and one helping with regulatory issues of the trial, which was very helpful as well. It was a lot to coordinate. It was a lot to coordinate, but it was very helpful, then, to have these long-termers, some of which now have been with us a year, a lot of that time in the field. When not in the field, they're working on the trial here and have provided some very, very important, very detailed field knowledge, which is critical.

Q: When you're talking about doing that coordination, especially still talking 00:48:00about the first deployment, what kind of stuff does that actually entail?

SEWARD: Well, it entailed a huge amount of clearance. Huge amount of clearance, at the time, because all the materials were being finalized. There were teams. The field team had a structure which I helped modify a bit to work in different areas, but we had people working on the standard operating procedures, finalizing procedures for how to evaluate somebody after they were vaccinated and how to do the vaccinations. That involved working with the locals to work out how to do it there, and then how to write how to do it. Those materials were coming back and forth to Atlanta and having comments from here that we may not have understood a regulatory requirement or something that had to be included.

Setting up the cold chain. There were lots of different aspects that had to be coordinated, so we had lots of meetings. I had areas of development with teams working on the standard operating procedures, a team working on the cold chain, a team working on training materials. I'm pretty good at delegating. You can't do everything yourself, you can't. I didn't have the skills, either, so I just got good people. I had great people, and just put them into teams and we got it done. My specific role was the CDC representative for the principal investigator for CDC, for STRIVE, and so I had daily meetings with this College of Medicine 00:50:00and Allied Health Sciences lead investigator, Dr. Mohamed Samai. I would have daily meetings with him, and then report back on decisions that came out of those meetings that were important for revising or modifying the protocol for the trial, and things like that.

I was reporting those things back. I was meeting with the CDC country director, Oliver [W.] Morgan, and the ambassador. Oliver had weekly meetings with the ambassador, John Hoover, to update him on the Ebola response. As we got towards launch, Oliver invited me to join him for the last part of those meetings and give an update on STRIVE. I would drive up to the embassy and join Oliver in the 00:51:00meeting with John Hoover and others. Those sort of things were very important because we had some challenges right around launch and we needed the intervention and assistance of the ambassador. Oliver was very helpful and knew how to negotiate those kinds of relationships with the US government.

Q: Let's dig into that. What were some of those challenges that happened at launch?

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 00:52:00that 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 00:53:00see 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, 00:54:00and so that took some time to get that worked out.

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.

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 00:55:00unit 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 00:56:00dialysis 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 00:57:00and 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.

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 00:58:00were 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 00:59:00with 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.

Q: A defibrillator?

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 01:00:00for 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 01:01:00extra 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.

We attended that meeting with the president himself, and he essentially said, 01:02:00"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."

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 01:03:00for 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 01:04:00for 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.

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 01:05:00Hoover'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."

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 01:06:00was it.

Q: I have a few follow-up questions about that whole process of getting it starting. Do you mind if I--I'm going to take a moment and organize my thoughts.

SEWARD: Sure.

[break]

Q: We're back. The first question I have, it relates to a larger question that we'll ask about the whole trial, but specifically about finding that money for the insurance. I'm wondering about funding for STRIVE. That sounds like something that was unprecedented, that you couldn't have planned for, really, and suddenly you have to come up with these several millions of dollars. Could you talk about that?

SEWARD: Well, the insurance didn't cost millions. We had to pay about three hundred thousand dollars for an extra $10 million of liability insurance 01:07:00coverage. Still, $300,000 was what we hadn't anticipated.

Q: [laughs] That makes sense. I got confused.

SEWARD: That's the coverage that was purchased. The total cost of all that, what CDC purchased, was three quarters of a million or so. Everything that we had to purchase for liability insurance. It was a fair amount, but an extra $300,000 was what we had to suddenly decide on.

STRIVE cost quite a lot, actually. The whole study cost a lot to do, and we were paying for all the deployments, of course, as well, and everybody. Thirty people in the field at any one time--it adds up, as well as all the other costs. We were fortunate in getting some appropriated dollars specific for STRIVE, 01:08:00separate from the Ebola response. Then also, BARDA contributed a substantial amount as well, initially, to the trial. That was very helpful. That was fiscal year--FY--it was October 2014 funding, that fiscal year. We used all that money and needed more funds to complete the trial. There was no further appropriation. Congress forgets pretty quickly. Money comes and goes. The new thing's Zika, which of course needs funding, but even before Zika, Ebola needed--there were needs to finish up a lot of important things like this. That was challenging. We 01:09:00had to piece together funds from different sources, and NIH [National Institute of Health] actually came through and helped us out with some funding to finish the trial.

Q: Thank you. My next question was, you mentioned that CDC and CDC Foundation couldn't buy equipment. I think you were referring to the renal dialysis equipment?

SEWARD: Yes. Very early on, before there were appropriated dollars, the Foundation helped with a lot of equipment purchases. Well, equipment and facilities construction. They did all the funding for the trial in the beginning, especially what was needed in-country. We had to renovate quite a few 01:10:00different facilities to be able to have vaccination in them. We built a new conference facility, or a STRIVE study center, the main headquarters during the follow-up of participants in Freetown. Then, coordinated some purchases of equipment--the freezers and things like that--for the cold chain, through the Foundation. That was very helpful. By the time the appropriated dollars came--and the Foundation also helped, I think, with--no, I think the insurance was paid with appropriated dollars because we knew we were getting appropriated dollars. By the time we got appropriated dollars, then they--you can only use those for some things. You can't use them for renovations and things like that. 01:11:00The private donations through the Foundation were critical, also, in getting STRIVE off the ground. And we couldn't use appropriated dollars for the renal dialysis unit. We couldn't do that and we couldn't use Foundation dollars for that either, because they had--by then, they'd been used for starting STRIVE. This didn't even seem related to STRIVE.

Q: It was just the--you couldn't find the right funding stream, essentially.

SEWARD: Yes. And it's not--CDC doesn't do clinical development and doesn't build capacity in clinical medicine. That's not our mission, which is why we had found another donor to help with the ICU. For that request from the government, we 01:12:00could only fund through the Foundation, technical assistance, and we could fund if they needed assistance in renal dialysis experts from around the world. We could send people in to provide guidance on what they needed. But we couldn't purchase the equipment. We would have had to find other donors like DFID or others for whom it was their mission to help with that. We found out later, as part of--and this was part of the important networking that I think you do in a position like I had in-country--that an Israeli aid organization called MASHAV, in fact, they were supporting renal dialysis there in Sierra Leone. They had brought people to Israel for training. They had had people come back and forth 01:13:00from Israel for training with doctors and nurses. They had purchased equipment. They were about ready to open the unit, but they had some issues with providing the right kind of water that was needed, that was clean, completely clean and safe to use in this equipment. Then they had halted everything at the time of the epidemic. I reached out to them, actually, and verified what I had heard from somebody else, a physician who worked at the hospital, to verify. In fact, we ended up bringing that up with the minister when we had further discussions, because it looked like they were double dipping, essentially. He probably just wasn't informed. This was something that was being done through the president's 01:14:00office, with a direct scientific project that was being run out of his office. I reached out to them, to MASHAV. I spoke to one of them by phone. I followed up with emails and just verified that they were committed to continuing to develop that capacity, and they were, so that was great. Any further requests for renal dialysis never came up with us and the Ministry.

Q: Really cool to get that story. So that's one of the big ways you were able to get past that requirement, essentially.

SEWARD: Yes. Well, I think at the time, the letter is what got us past the requirement. We committed to one hundred thousand dollars of technical 01:15:00assistance and other assistance as needed through other donors. We, in fact, were never asked to provide that in the end. But the letter is what got us to open STRIVE, I think, was having that letter and saying we were committed to trying to help. Mainly working with other partners. They then didn't come back and say, "What are you going to do?" They asked a few times, and then in another meeting, in one of these follow-up meetings the ambassador had suggested we keep having, we raised this issue of the Israelis supporting this, and then said, "It appears this is covered. Let us know if it isn't." And we never heard anything else. And I'm not going to bring it up again. [laughter]

Q: Sounds good. You probably have mentioned this and it just flew past me. You 01:16:00mentioned, and I'm probably mispronouncing it, Connaught Hospital?

SEWARD: Connaught.

Q: Connaught Hospital. Is that the only site, or are there several sites?

SEWARD: There were seven sites that we were vaccinating in. We conducted STRIVE in five districts in Sierra Leone, or five states, equivalents. Those were the districts that had a high incidence of Ebola at the time we made a decision to do the trial, and these were reevaluated right before--fairly soon before we launched. They were areas where we could develop the cold chain capacity, and where there was an adequate population of health care workers to vaccinate. To offer vaccine to, for STRIVE, because we wanted to enroll at least six thousand people, so if we were in a very remote, small, rural province, we mightn't get 01:17:00the needed sample size. The epidemic had started in some of those remote rural areas, which was why, I think, it was challenging to identify the epidemic, initially. Then it was peaking in Freetown itself, in the biggest city, and in some surrounding provinces at the time we launched. We did it in five provinces and had seven different sites in those five places to enroll and vaccinate people.

Q: Right. Were you--did you split your time between sites, or--

SEWARD: I would visit them. We had staff on the field team who were assigned specific roles, and so I was pretty much--they were reporting to me. I went and observed at almost all the sites, and including the follow-up--so, there were 01:18:00seven vaccination sites and three follow-up sites. Two of them were the same physical area, but different locations. One was doing vaccination and another was using different rooms for the participant follow-up. Physically, they were the same place, but they were quite different functions. We had ten different things going on. Vaccination and follow-up, and then we had the cold chain sites, which were different as well, where the vaccine had to be diluted every day and delivered in the syringes to these sites. That required a standard operating procedure for the trained pharmacists to correctly dilute vaccine and draw it up into the syringes. That's usually not needed for vaccine 01:19:00administration. Usually you just take it out of a syringe. You might have to mix up a freeze-dried version of the vaccine, like we do with MMR [measles, mumps, and rubella] and varicella vaccine, with a diluent, but we had to, here, mix up a freeze-dried--no, it was a frozen liquid vaccine. We had to let it thaw out, then mix it with saline, and then draw up twelve syringes from that mixture that were the appropriate dilution, and they had to all be carefully labelled and carried at a certain temperature. There were three sites doing that as well.

We had different people on the field team who were helping watch vaccination, helping watch follow-up, helping watch the cold chain, and I was just doing spot 01:20:00checks to understand the process and to meet with our staff in the field as well as with local leaders, over all that. We'd have field team meetings. We had people out in some of the rural areas, and so we would supervise them by phone. Three times a week, we would meet as a field team, twice by phone. In person if you're in Freetown, on the phone if you're out in Port Loko or in Makeni or in Tonkolili. Some of the rural sites. Then people out in those sites would come in for the weekend to Freetown, and then we would have a two-hour field team meeting on a Saturday. We pretty much were working seven days a week, or at least six, and would have a two-hour, often went for three hours, in-person 01:21:00meeting on Saturday and go over everything that was being done. That's when I'd learn about problems or help solve problems. When the people came in from the field, then there'd be lots of small group meetings about specific issues that had to be dealt with as well, which I sometimes would join as appropriate. Then we were meeting with our implementing partners there, too. We couldn't do all the things in-country that we needed to do, like go buy the tables and chairs and the equipment for all the vaccination, and so eHealth Africa was our local implementing partner. I was meeting with them frequently as well to troubleshoot and deal with issues that were like, there aren't any pregnancy test kits at the site today, or what do we do? We've run out of this, we've run out of this. Challenging. Those logistic things, which we don't even think about here, they 01:22:00were a daily crisis there, actually, even after we launched. There were daily issues with eHealth not being able to provide on time, sometimes, everything that was needed, due to all the challenges there.

Q: Do you remember any particularly scary moments?

SEWARD: I think we had some challenges initially, not that I directly experienced, but that my staff talked to me about, with such a demand for vaccine that we had crowd control challenges. With hundreds of people showing up and pushing and shoving to try to get in line. I think we were very gratified by 01:23:00that, but it was also challenging because there weren't a lot of staff that were able to step away from their usual job to do that kind of crowd control. We got help from security guards there, and I think the embassy helped us with some security to help with that. It was a good thing there was interest, but it was hard for people, if they were working. A lot of them were then, which is why we enrolled them. They would have to come on their day off, or get permission to. Because it took most of the day for them to enroll. The enrollment process was quite lengthy. They had to be consented, they had to first be screened, to see 01:24:00if they were eligible. Women had to have a pregnancy test. They had to wait for the result of that test. They then had to be enrolled. That took an hour, an hour and a half, two hours to go through that whole process, make sure people understood. Local staff were doing all this work. The day-to-day work was being done by trained Sierra Leonean staff. Then, they went and got vaccinated, and then they had to be observed for an hour to make sure they didn't have an allergic reaction, and then they got compensated. They had to wait for their compensation, once we were paying it in cash. They couldn't come back day after day, and they wanted to be enrolled the day they came, and so sometimes there was some challenges with crowd control. But no, I think there were issues like, 01:25:00has somebody had an allergic reaction? We had a call about somebody's short of breath, and it's like, oh gosh, is this going to be the first allergic reaction? But they were just nervous, I think, they were just having a panic attack. But we had all the processes in place, including an ambulance close by, and things like that, for those eventualities. We had to.

We had challenges with the cold chain. I never considered myself the expert in any of these areas. Had to rely on those that were, and know who the right person was to call. So that's what I did. I had adequate, very good staff, and we had a good person over the cold chain, and so if something happened he took 01:26:00care of it. He or she. We had firstly somebody from BARDA who was there for a couple of months helping it get set up and training done, and then BARDA contracted with Modality Solutions to have somebody in-country. One person in-country all the time. And Sierra Leoneans had been trained, so they were very good. Learning to manage themselves, but always with some oversight. Now, Modality Solutions have left, and they're managing the cold chain remotely. Because we're not vaccinating now, and the local staff have stepped up and they're adequately trained. We had a recent situation with a freezer going out, and there were situations where you can lose power from the electricity--if you 01:27:00even have it. In one area, we were off the grid. There was no grid, no national power grid where we were. You can lose electricity, a generator can fail. A back-generator can fail. Some of these generators that existed are old and they are not maintained as well as they might be, and they'll fail. Then you might not have the piece to fix it, there and then, so you need a backup to the backup generator. Then we had solar batteries, and sometimes the--we were trying to set up an automatic switch so that if the battery went out, the solar batteries would switch in. The switch wouldn't work, or something. So you had to have multiple redundancies and ways to call people when things went wrong and deal with each new situation as it emerged. That's what we did.

Q: You mentioned the person from BARDA. Were there others who were good to rely on, to call people, people to call when things went wrong?

SEWARD: Well, I think BARDA were--I mean, they were fabulous for the cold chain. CDC doesn't really work in that area particularly, and so we had an excellent person from BARDA who was there for two or three months in the beginning and then they contracted with Modality Solutions to oversee that. We knew exactly who we had to call, and they would call us. They were "on our team," quote. They would come to our meetings, attend our in-person meetings. They were a member of the team, of the STRIVE field team. There were very good working relationships with them. We had newer points of contact in eHealth, and so if issues arose with supplies and things like that, we knew who to call.

Q: Any specific individuals come to mind?

SEWARD: Yes. We have Michelle Rose is the director in-country now. She wasn't there when I came, but she came about halfway through STRIVE. Dayo Spencer-Walker. She's actually African American, but Sierra Leonean ancestry. She grew up in Los Angeles, but her parents are Sierra Leonean, so she has relatives there and she speaks Krio, so that's very helpful. Then Elianne Furrer, who was--Dayo is the current project manager, and before her, Elianne Furrer was. They've both been very good to work with. It's challenging for them, too. They took on a lot at a time where they didn't have a lot of in-country 01:30:00capacity. We were all learning and flying the ship as we were--building the ship as we were flying it, basically. It was a challenge all around.

Then, people on the CDC team. We had a project manager. We still have her. Rosalind [J.] Carter, who is currently the field team lead in-country. Rosalind has been a very, very critical part of the team. We had a clinical trial nurse, still have, Wendi McDonald, and Wendi went down. She used to work at Vanderbilt [University], at the clinical trial unit there, so she had experience with conducting clinical trials but no experience in a developing country. Seeing a clinical trial done in Nashville versus in Freetown was very different for her. She trained the nurses to give the vaccine, and oversaw that aspect of things, 01:31:00and learned how you do things in a country where you can't just get on the computer and do it.

You may not have air conditioning, you lose internet connectivity, you can't contact people through the internet, you have to use the phone or go in person. Yes, you had to know who to call, but people knew to call you, too. We had a very good structure in the team, and people would bring things to my attention when things went wrong or when little issues like that arose.

Q: Were there local people who you found yourself interacting with quite a bit?

SEWARD: Well, of course, I interacted daily with the principle investigator, Dr. Samai, so absolutely. Also very frequently--Rosalind did more day-to-day with 01:32:00Ayesha Idriss. She was the Sierra Leonean project manager, and we had very close working relationships with her because she did a lot of the day-to-day work there. Then, depending on roles, I wasn't spending all my time at the site, so Wendi, who did spend every day at the vaccination site, she worked with the main nurses there and knew them by name and all the staff there. The managers at the follow-up sites, we didn't put any in place initially, which was an oversight on our part and something that I recognized and suggested that we change, that we really needed somebody managing all the staff who were doing the follow-up. We had the staff doing it, people to call the participants every month, nurses to 01:33:00deal with phone calls from ill--because we were providing free medical care, but nobody overseeing their work at a site-specific level. We eventually did. We made the recommendation that we needed those people. Dr. Samai quickly moved on it and got some good people in. Those people have been critical, really critical. We then identified some other gaps.

I think one of the more important achievements from my perspective, with the trial, we were very cognizant from the very beginning about capacity building. That was a very important objective of this trail, was to build capacity in Sierra Leone to do this kind of work, because they hadn't done an investigation or a new drug trial before. We were training three hundred fifty people to do it for the first time, including the senior people.

I think I saw, as time went on, that our core team, field team, sort of evolved into--we needed somebody over in medical management. So we got a call--we hired somebody. We actually hired another African American of Sierra Leonean descent who was a physician, ID [infectious disease] specialist working in Chicago, who was interested in a year of sabbatical. Or taking a year of leave and volunteering in Sierra Leone--working in Sierra Leone. We got her on board, and we could see with time that having a one-on-one Sierra Leonean working with those lead people, like Ayesha was working with Rosalind, somebody to work with 01:35:00our person there in medical management--Olamide is her name, Olamide Jarrett. And then somebody to work in regulatory with the BARDA person would be very helpful for building capacity. I made those recommendations to Dr. Samai, and now we have some really outstanding people in those roles that are working very, very closely one-on-one, and I think we're really building some very sustainable capacity.

Q: Was it still in the first deployment when that change started to occur?

SEWARD: No, the first deployment was--I don't think I had time to think about anything, but just getting the trial through the day, or just dealing with all the things that were still--we were still building the plane as we flew it, and so it was fine-tuning. It was two hundred people have shown up today here. How 01:36:00many should we enroll? The trial has to be monitored externally, and we had another partner there, FHI [Family Health International] 360, who were doing that. They were looking at all the paperwork and making sure everything's being done correctly, externally from us. I think in retrospect we probably enrolled too quickly and then put huge pressure on FHI, because they couldn't keep up with the paperwork of our enrollment. We probably should have gone a little slower in the beginning, but there was just so much still being fine-tuned and working out the kinks that we didn't even see those issues until well into the second deployment. We were starting and we were also rolling out these seven 01:37:00sites over a time period, and so we didn't start them all at once. We started one and then another one, and then one up in the rural areas, and one--in Port Loko District, we had three sites, but we had two teams. One team did enrollment vaccination for three to four weeks, and then they moved to the seventh location and opened that site last. It was actually a lot of coordination and effort to get seven sites going. I think if I had it to do again, I'd probably say, let's go with a few fewer sites. It's just challenging, really challenging, both to have your own staff there, but also to oversee all the local staff, or help oversee them. It was Dr. Samai's job to do that, but we had people there that 01:38:00could answer questions and help them from a technical perspective. I think I didn't even see those issues until well into the second deployment, when things had started to calm down and things were running a bit smoother, and then I could see, well, we didn't put site managers in place in these three follow-up sites. We had site managers for vaccination, but not specifically for the participant follow-up, which was a parallel, equally important activity. We dealt with those issues as they got recognized, and I think it was good to get them in place when we did. It would have been better in the beginning, but we didn't see it in the beginning and I think that's understandable.

[break]

Q: Another thing that I'm thinking about is--and you were talking a little bit 01:39:00about this before we stared recording, was the communication side of it. Communicating about the trial to the news media, to the population, given that there could be rumors going around about what the trial is about. Can you talk about your work in that part of it?

SEWARD: Yes, that was actually quite a lot of work in the beginning as well. Both very important work that Dr. Samai did. Backing up on that, there was a lot of concern before the trial started about whether there would be acceptance of the vaccine, whether there would be rumors that the vaccine would give you Ebola because it has a dead piece of the Ebola virus in it. The vaccine is made from a different virus, but a gene, or a protein made by a gene in the Ebola virus is put into this virus to express that. No, the gene is put in that expresses the 01:40:00glycoprotein that allows the body to recognize that they're seeing Ebola virus, seeing the main thing that triggers the immune response to Ebola virus. The Ebola virus glycoprotein. Explaining those technical issues to people is challenging. We had to first do some research and understand people's attitudes and beliefs about vaccine and about Ebola. Again, this was funding from the Foundation initially, I think, to do this research with a group in-country called FOCUS 1000. They are experienced and they're good, and so they did extended, lengthy, individual interviews with community leaders and designated 01:41:00public health officials, and some with health care workers and frontline response workers who were [going to be the group for] enrolling. They did a lot of focus group research. Interviewing hundreds of them, actually. And then in the communities as well because we knew that you had to educate the community as well, and stakeholders.

In the communities--because these people were going to be volunteering and enrolling in their communities--the vaccination clinics were going to be held in districts, and so people had to understand, these people went back to families. They were part of families. We got the research done, identified concerns and how to address them, and then developed materials that we used in STRIVE. We did 01:42:00a lot of outreach before the trial. Amy [L. Callis] would be able to tell you a lot more about it because she went to all these meetings herself to do this outreach. She lived in Sierra Leone for about eight months, including before the trial, and went to meet with the chiefs, with the district chiefs, paramount chiefs, important people, and answered questions. Then we had information sessions in all the facilities where health care workers worked. Health care workers and frontline response workers. Where we could be enrolling from.

We did between one hundred fifty and two hundred individual sessions where 01:43:00people could show up at these sessions and we would give a talk. We worked with local pharmacy students, pharmacists, they were just graduated from the College of Medicine and Allied Health Sciences, who became very good at doing this in Krio and understood the issues. We would often be there just for backup questions. People could listen to the talk, ask questions, and then stay, and there'd be a signup sheet for a specific day where the vaccination was going to be at the Connaught Hospital or the local place where they lived, and they could then sign up and come on that day. We tried to have some control over when people would come. Some, but we couldn't have all. You couldn't do appointments because we didn't know who was going to come, initially. We did that kind of 01:44:00signup, but people could just come. They didn't have to have an appointment. That's why we dealt with these crowds, initially. But we did all those information sessions, and so I think there was a lot of information out there. When we launched, before I got there, there'd been a big press event that Danny Feikin attended with political leaders in Sierra Leone. When I was there, there was an official launch event when they opened the clinic in Freetown at Connaught Hospital. It was at Connaught Hospital, and so the vice minister of health attended that and the principle investigator from Sierra Leone, the ambassador from the US, Oliver Morgan as country director, myself. Everybody 01:45:00said something. Press conferences in Sierra Leone go on for a couple of hours, so speeches would last forty-five minutes to an hour. Then there'd be a few questions, and then after those events, there was then a formal launch at each site. At each rural site, there'd be local leaders invited, local important partners.

We had to have partnership with all the laboratories that were testing and the Ebola treatment units because if anybody from our study got Ebola and then went to a treatment unit, we wanted them [the treatment unit staff] to know they were a STRIVE participant so they could take an extra blood tube for us for testing under special laboratory standards for a trial. They would get tested in the 01:46:00national response, but then we had to have another tube of blood that we would transport to the CDC lab in Bo for the special testing as well for the outcome for the trial. We had made a lot of presentations to those Ebola treatment units as well, to educate them about the trial.

When we launched, we had each individual launch event, and then we did a lot of media interviews. We did, and Dr. Samai did, and the Ministry [of Health and Sanitation] did some as well, but I went to quite a few. Did radio, mainly, because that's the main source of information, TV is not commonly used there. I did a number of radio interviews in the evenings, usually. They had a lot of talk shows and call-in shows that they'd done, they were doing, to educate the public about Ebola. This was part of the time where they realized that they 01:47:00really needed to get the word out, country-wide, about Ebola. I went to some of those where they were giving, "This week's statistics, we've had this many cases of Ebola in this district and this district, and there are this many people under quarantine." Then they would have a segment on the trial, and you'd get good questions like, what about us? What about the local--everybody? Why just health care workers? We'd answer those kinds of questions and try to educate people about why this trial was being done, why it was being done in the population we chose--because they were at very high risk of getting Ebola, much higher than the general population.

Q: Thank you for that. I actually remembered my question from earlier, finally. [laughter] It's when you were talking about all the local staff and international. Do you know how many total local and international staff might 01:48:00have been working on STRIVE at any one time?

SEWARD: At any one time? Well, there would have been close to four hundred local staff that were employed for the trial at any one time, at the time where we were enrolling and vaccinating. That's when we had maximum staffing for the trial, because we were enrolling and vaccinating. Enrolling and vaccinating for those who randomized to the immediate vaccination group all occurred in the first three or four months, and then we did vaccination for our deferred participants, those that randomized to deferred vaccination. Because it was an individually randomized trial. People picked an envelope out of a basket and got 01:49:00told, "Immediate," they were going to get vaccine that day, or "Six months later." People would open the envelope and some would be happy, thrilled that they were getting it that day. Some would be really disappointed because they wanted to get it that day. Some would be relieved they were not getting it that day. They wanted to see what was going to happen, with safety and things like that. Some would be disappointed they were deferred because they wanted to get it that day. We had maximum local staff working on the STRIVE trial itself in the beginning, so over four hundred. That included people that have continued working on the follow-up, and all the phone operators that we used for people calling in with medical illnesses. For CDC at any one time, the biggest number 01:50:00was thirty or thirty-two or something when I was in the field, in the field. But then we probably had ten or twenty people here [in Atlanta], twenty people here working on STRIVE. Probably about twenty. And then you had--so, are you just talking CDC, or--

Q: No, other partners too. Anyone involved in STRIVE.

SEWARD: Well then, eHealth Africa. They've probably had a team of ten or something like that. FHI 360 have had a rotating team of people in-country, and others back here supporting them as well, probably ten or twenty people from FHI. Sometimes they've had twenty people in the field, maybe, because they've 01:51:00had to have people observing at each of the seven vaccination sites, and at each of the follow-up sites. Emmes, who are an agency that we're contracted with to manage all the data, they do all the safety reviews. They have medical staff who are familiar with monitoring for serious adverse events, which is a very important safety outcome. One of those people, Dr. Bob Lindblad, has been down in Sierra Leone a number of times, and then he's at this end, in North Carolina. They manage all the data, so we have regular calls with them. The data is entered in Sierra Leone and uploaded to them, and then they review it, and we'll have questions like, "This person got admitted to hospital today with this. We're not sure exactly what this diagnosis is. Can you check what they--" So, 01:52:00questions are coming back and forth on the data, on an ongoing basis, to clarify exactly what each condition might be that's being described and resolve any questions. BARDA, in Washington, have been very important. They've probably had five to ten people at different times working on the trial, some in Sierra Leone and some here. TRI, Technical Resources International, they're another contracting group. They have the contract with BARDA and a subcontract with Emmes and FHI 360.

Modality Solutions, two people working at any time from them. WHO helped set up the cold chain initially, so a few people, half a dozen, maybe, people at 01:53:00different times from World Health Organization. Who am I forgetting? The Ministry of Health, of course. Some of the people working on the trial were the Ministry. Of those four hundred, some of them are from the Ministry of Health. The bulk of them are from the College of Medicine and Allied Health Sciences, but some of them are from the Ministry of Health and Sanitation. Those are our two important collaborators, day-to-day collaborators for the trial. I think CDC's had--we've had a couple of hundred people deploy through the field. That includes counting people like me three or four times, that have gone three or four times. But we've had--

Q: That number of deployments.

SEWARD: Yes.

Q: I want to add that up later, because it's quite a few. You probably don't 01:54:00know off the top of your head how many total different individuals were involved. It would be much more than at any one time, of course.

SEWARD: You mean, people working on it, or enrolled? Participants in the trial?

Q: Enrolled, it's 8,016, am I right?

SEWARD: No, 8,673 enrolled, and 8,016 vaccinated. Not everybody that got enrolled got vaccinated.

Q: Can we talk about that?

SEWARD: Yes. Initially, people got randomized to immediate and deferred. Ninety-five percent of those that got randomized to immediate got vaccinated. Some did not. Some, even though they were informed in the beginning that whatever they got randomized to meant they would get vaccinated, some people changed their mind after they enrolled, and so about four percent or so of the 01:55:00immediate group didn't get vaccinated, so that's some. Then of those that were randomized to deferred, they then had to get followed up monthly. Some died. A few died. Some women got pregnant, and so they then weren't eligible for vaccination. They were enrolled, but ineligible for vaccination. Some might have had some other conditions discovered that made them ineligible for vaccination as well. And then there were some with deferred, like immediate, that decided even though they were eligible they didn't want to get vaccinated in the end. So, a small number. That's the six hundred people that enrolled and didn't get vaccinated.

Q: That makes sense. Why did you have immediate and deferred groups in the first place?

SEWARD: This was an attempt to have a concurrent parallel control group for efficacy and for safety. We didn't use a placebo. In Liberia, NIH had started a study before we did that was a randomized control, placebo control trial, testing two vaccines, two different vaccines, against placebo. In Sierra Leone, the country wasn't keen to use a placebo. We were at the real height of the epidemic when this was all being discussed, and there was thought to be an advantage in using some different designs in case any particular one failed for different reasons. We chose, initially, what was called a stepped wedge design, but then changed it to an individual randomized design, and that allowed the 01:57:00group to be randomized. That's an advantage in a trial. You're controlling who gets--it's random who gets assigned immediate vaccination or delayed vaccination. The delayed group, though, are unvaccinated for six months, and so for that six months of their unvaccinated person time, they're the control group. They didn't get a placebo, so there is some disadvantage for safety, but for efficacy we didn't really see much disadvantage at all because Ebola's so serious, we didn't think we would miss cases of Ebola. Turned out we didn't have any cases of Ebola in our vaccinated people, so we weren't able to get efficacy from the trial. But the safety data, it's much better to have this concurrent 01:58:00control group than to have no comparison. We felt that even though it wasn't placebo controlled, we had a concurrent control group. Things like malaria and things that were seasonal, they would occur in both groups. Reasons for fevers and things like that. We could always compare the vaccinated group to the unvaccinated group.

In addition to the overall study, we had two sub-studies, and one was a detailed safety sub-study that was--when we launched this trial, there was hardly any information on safety in humans. There was some, but at this dose, there were phase one studies. We're talking less than one hundred people. There were ongoing phase one studies involving hundreds of people, but at the time we 01:59:00launched, you only see rare events for any vaccine when you roll it out in big numbers, and that's what happened with rotavirus vaccine here in this country. We only saw intussusception when we gave it to a lot of children. It wasn't common enough to see in the early trials, to see something that occurred one in five or ten thousand, or two thousand, people. A phase one trial's not that big, and often a phase two or three trial isn't that big. We had a safety sub-study that, for the first four hundred people enrolled, two hundred were vaccinated, two hundred were not because they were randomized to deferred. They had very detailed phone follow-up for safety, with phone calls at day one, day three, day seven, day fourteen, and day twenty-eight. With that kind of follow-up for both 02:00:00groups, we got very similar things reported by the immediate and deferred in all the time periods, except for immediately following vaccination. We could pretty confidently, then, attribute those differences to the vaccine. Things like more fever, headache, muscle ache, joint pain, abdominal pain, fatigue. Those occurred a few days--within a day--and for a few days after vaccination in the immediate group. There were some in deferred, but there were some in deferred all the way along because people have malaria and other things as well that were also occurring in immediate.

The difference, we felt, we were pretty confident was due to the vaccine, for the safety sub-study where they were calling people and asking them specific 02:01:00questions. That's why we had the unvaccinated or deferred group and why we had the design that we did. We felt like it worked--it was a good compromise between not using a placebo control but still getting some very valid scientific information.

Q: Thank you for that. To get back into your life chronology here, so you went on your first deployment, you came back from the first deployment when?

SEWARD: End of June. Sorry, end of April.

Q: End of April. Okay.

SEWARD: Went back in June.

Q: So you're here, end of April until, for about a month you're in Atlanta?

SEWARD: Yes, actually most of that time--I forgot when I mentioned it before--I wasn't working on STRIVE. I actually had another thing I had to do for the [National] Center [for Immunization and Respiratory Diseases]. I was the representative to a vaccinology course that's held for two weeks every year in 02:02:00France, and so I had to attend that course. I came back, I had two children's graduations to attend as well. A son from medical school and a son from an MBA program in California, so had to fit those in, too. Very important. So I was not doing a lot for STRIVE in May. In June, I started again and then went back to Sierra Leone for another two months.

Q: Right. Are there any major developments or challenges that happen in that second deployment that you haven't talked about so far?

SEWARD: I don't think so. I think as things started to get stabilized with 02:03:00rolling out all the vaccinations and things like that, I think that's when I, through the fog, could see some of the gaps that were clearer in the staffing and things like that. Just a few positions that we hadn't anticipated that I think were then very helpful to get in place. Also, for our own team. We were fine-tuning, still trying to hire people for the field team for CDC. I think one of the challenges, if it was a challenge, for the second deployment is that around that time, during that second deployment, the ring trial in Guinea published their results. That was suddenly, looks like this vaccine might--looks 02:04:00like it works. These were preliminary results, and the results weren't statistically significant, given the handicap you get for an interim look at trial data. You're not supposed to keep looking. You get handicapped with a statistical error when you do that, and so you have to be careful and not look unless you think you really want to look. But the data was very encouraging that the vaccine worked, and that's the same vaccine we were using in STRIVE. There was an immediate call, then, for educating people, informing people. I was in-country and so I wrote up a summary for the ambassador and went and met with 02:05:00him, with Oliver, and informed him about that. I think there was then an immediate sort of interest in vaccinating, should we--because WHO then stopped randomizing in their trial. They were vaccinating contacts of a case, and contacts of contacts in their design. They were randomizing around a case, the contacts, to either immediate or three weeks later vaccination, so that was their trial design. It was a very clever, ingenious trial design, and they stopped randomizing after those results and offered everybody vaccine.

Since it appeared the vaccine was working, then the question came up in all the other countries, should we be offering vaccine in a response? If so, how can that be done? Because this vaccine's not licensed, so you have to give it under 02:06:00a protocol, or a strict research protocol, ideally under an investigational new drug protocol like we were doing STRIVE. The question came up, will STRIVE modify it? Will CDC do this? Will STRIVE modify their protocol? Will we have a new protocol under STRIVE for the ring? Will WHO modify their protocol in Guinea to bring it to Sierra Leone for the ring? There was a lot of coordination and discussions, both in Sierra Leone, with WHO Geneva, with the lead for WHO trial who was from Geneva but was currently in Guinea, and with CDC here in Atlanta. That was occurring in August, late July, August, and on my way back here I stopped in Conakry and visited the ring trial headquarters there and spent a 02:07:00couple of days looking at how they did things then to help inform what we might be prepared to do. People that don't understand that an IND [investigational new drug] trial, it's very cumbersome and a lot of work. It's very different from a vaccination program, so people who didn't realize that thought, we can just start offering vaccine. Well, you can't.

Firstly, you have to have -80°C freezers. You have to dilute it, you have to be able to carry the vaccine at -80°C to wherever a case in the country will occur, you have to have informed consent, you have to educate people to do informed consent correctly. They have to understand they're taking a risk. There's a risk. There could be a benefit, there could be a risk, this vaccine may not be completely safe even though things looked good for what we had seen 02:08:00and what the ring had seen and what PREVAIL [Partnership for Research on Ebola Virus in Liberia] had seen in Liberia, and none of that was published, apart from the Guinea data. That was a lot of work both here and in Sierra Leone at that time. In the end, WHO decided--it was decided it was easier for them to modify their protocol and bring it to Sierra Leone, and that we would help with cold chain if they needed it. But there was a lot of back and forth and discussions around all that, at the end of that second deployment.

Q: When you say that WHO decided to bring it to Sierra Leone, what does that mean?

SEWARD: Well, they had a protocol approved in Guinea, and so they agreed--there were basically two protocols open. Well, there was only one open in Sierra Leone. That was STRIVE. We had discussions with the FDA about what would be 02:09:00involved in us having a ring response protocol under our IND. We would have had to have written a separate protocol and could've done that, and had a separate group. I made clear, very clear, that STRIVE personnel could not staff that. If CDC wanted to do the ring in Sierra Leone, I made it clear from the STRIVE perspective that we would help in whatever capacity we could, but we didn't have the staffing to take it on, either on the CDC--so, it would need a whole other lot of CDC deployers to do that. We couldn't dilute our people to start working on another trial when we had a huge amount to do with our trial. But that was one option. We could have written a new protocol, or found CDC people to do that, to do the ring response in Sierra Leone. Or, WHO could take their Guinea 02:10:00protocol, translate it from French into English, and make a few modifications and ask to have it approved in Sierra Leone. They were prepared to do that and that seemed like that was the easiest path to being able to do it quickly in Sierra Leone as needed, because they had trained teams, they could drive from Conakry into Sierra Leone as quickly as they could drive to remote parts of Guinea, actually. Because Conakry is only a half hour flight. It's a short hop from Freetown to Conakry.

That's what they did, and in fact, in September, in late September, a case occurred in one of our study districts, and we then had to do a lot of 02:11:00coordination with WHO because they were offering the ring [trial in an Ebola response]. They drove down from Conakry, sent a team. Sierra Leone trained a team as well, by WHO to meet them. They worked together, but we had STRIVE people who were enrolled, not yet vaccinated, and they could've been a contact of a case. Some were, so we wanted to--we worked with WHO to try to inform people that they could choose to take the vaccine in the ring, but then they couldn't get it in STRIVE because we wanted safety to be done clearly. You don't want double vaccine doses if you're trying to look at safety of one. That required a lot of coordination and work that started during that second deployment and then continued on during my third deployment, because there was 02:12:00another--there were cases in--cases in Bombali, Port Loko, and then recently another case in Bombali again, that they've done a ring response for. We had the vaccine expertise, and so were very helpful to the CDC country office in advising them how to approach collaboration with WHO for the ring protocol and things that CDC could or could not contribute, a lot of which was being discussed back here because Oliver was back here now, as the Ebola lead in the EOC.

Q: That makes a lot of sense, thank you. It sounds like the dilemma is a little bit like weighing trying to protect people immediately with knowing, with 02:13:00getting the data to protect people in the future through study, but then weighted down with the fact that there are these logistical concerns that you mention.

SEWARD: Yes, the vaccine's an investigational vaccine, still. It's not licensed for use, and so it has to be used under very strict conditions to study, still, the safety and how it works, and people have to be adequately informed of that. There's a lot of paperwork and a lot that has to be done to deliver vaccine that way, as opposed to a licensed product where people need to be informed of risk and benefit, still, but they don't have to sign informed consent for that because all the work's been done that just informs them, then they make the decision whether to get vaccinated or not, they don't have to sign anything. But for a trial it's--you can't just roll it out in a ring response quickly. It 02:14:00certainly was quicker for the solution that was taken in Sierra Leone for WHO to do any immediate rings that occurred.

Q: That helps. That was coming up in the second, and you said kind of into the third deployment. Can you remind me when your third deployment was?

SEWARD: Third deployment was end of September until into the end of the first week in November. That was really a time of fine-tuning, I think, the staffing and day-to-day working of the trial, and then also managing the field team with a much smaller team and trying to fine-tune that. How many people did we really need, because it was getting harder and harder to get these deployments. It's 02:15:00been a huge amount of work here to keep the deployments going. We're still needing some now, and we've managed, but it gets tougher with time because programs are maxed out with people deploying, and now they're being asked for Zika and we still have Ebola requests.

I think in that last deployment it was just doing some of the fine-tuning with the COMAHS [College of Medicine and Allied Health Sciences] staffing and our staffing and day-to-day management of the trial, looking into this year, and trying to plan out the field team longer term. And it dropping down, and staffing, with time. What did we need, and how long did we need people? That was always a lot of work for the field team lead, was to advise on people coming for 02:16:00the field team. They'd line people up here and then you'd look at their CV [curriculum vitae] and say, I think that person might work well for this position, or not. Doesn't have the skill set we need, we need a medical person or a nurse or a person with clinical experience in this position versus this position. We need logistical help here, and sort of working out all the--going through staffing calls with people here to finalize all the deployments.

That's ongoing, and as people come to deploy, sitting down with them and orienting them to the work. They've had an orientation here, but now they're there and so you sit down and you orient them to the work there. Some of them are EIS [Epidemic Intelligence Service] officers, so it's their first international deployment, usually, so making sure that they were comfortable. We had great, great EIS officers coming out. Just a really, really great group. 02:17:00Still have. We've got two out there now. They've provided some critical manpower for us.

Q: Anyone you want to cite specifically?

SEWARD: I think there's been so many. They've all been great. I think every single one of them has been really fabulous. We would have liked to have had multiple deployments from some of them, but naturally, they've got a lot of things they have to do. No, it's been--they've been really, really great. But you want to be sure that they know who to go to, they're adequately supervised. Very strict instructions about who's going to supervise them in the field, so you can't just throw them in. You've got to make sure they know who to call, follow up with them, see who's supervising them, make sure that's working, be available on the weekends when they come in from the rural areas to have those discussions. Then making sure people take time, don't exhaust themselves. The 02:18:00stress was pretty amazing. I deal pretty well with stress--I've been described as a stress seeker--I don't know what that means, but I guess I--I was working sixteen to eighteen-hour days, six or seven days a week. No question. Because oftentimes all the conference calls with here were at 5:00, 6:00, 7:00, 8:00 pm. That was our workday, and then you'd eat, and then you'd get on emails, catch up with all the emails still flooding from Atlanta because they're four hours behind. That would take until midnight or one or two, and then you'd go to bed, and then you'd be back at seven thirty at the country office meeting and having 02:19:00breakfast before that, because I would have to leave right after that, too, for the one hour drive across town to get over to meet with Dr. Samai.

So they were very, very long days, and everybody was working long days. It takes a toll, and you have to be very cognizant of the team, and make sure that people are not overdoing it, that they're taking a break on a Sunday and trying to get to the beach or do something like that. People were, I think, very good on the team in supporting each other, because some of the long-term people there, they were there for a number of months--much longer than I was--in a row. That's exhausting. It really gets exhausting, especially if you don't have a lot of international experience. Some of our new people going out, it was a culture shock just to leave the States, and then to get to a country where there was an 02:20:00Ebola epidemic, you couldn't go out, there were just different constraints with that that had to be dealt with. Washing your hands all the time, before you went into a building. Every time you left the hotel, you couldn't get--that were just extra demands, and then communications were challenging. We had wireless at the hotel, but in the evening--it was nice to work in your room and do your emails, but you'd lose your Citrix connection over and over and over again. You'd have all your emails lined up and then you'd lose the connection, and so you'd have to go and work in the lobby, or in what we called the Cave, which was the CDC EOC. But that's down underground, and all dark, an artificially lit room, so not a fun place to be often.

Those challenges made something that could be fifteen minutes, it took an hour 02:21:00to do because of challenges with connections, and the same with contacting family. You'd be on Skype and then the call would drop. It required adjustment and it required watching all the people you were responsible for to make sure that stress was not adversely impacting their lives.

Q: Tell me about your work since returning from your third deployment.

SEWARD: Well, I've been working on this side, and in between the deployments as well, helping--I was co-leading the STRIVE team here when I wasn't in Sierra Leone, from about the middle of last year, with Susan [T.] Goldstein. We needed two people here. I think it was tough for Susan when I was there. It was easier 02:22:00when I was there in some ways because I knew the field so well. On the other hand, there was only one person here to make decisions at this end. So, I was helping with that. In January, we had a new lead come on because I couldn't commit to the end of the trial. The trial's going to go well into 2017, and by that time I'd made a commitment to start some part-time work after I leave CDC with the Task Force for Global Health. My departure date kept getting changed, and it made longer and longer. The Task Force had been waiting for me to start with them, and so I couldn't commit into 2017 because I told them I'd start sometime in 2016. We sat down with Anne Schuchat and said I couldn't stay until 02:23:00the end, and Susan wasn't sure she'd be here until the end either. So Anne got another lead in, which was great. Dr. Barbara Mahon joined us at the beginning of January, and she has been full-time since then. She took over the lead, and now I'm senior advisor to her, or to STRIVE, and am just starting to transition out. I'm going back to Sierra Leone next week for a couple of weeks in the field again, filling in a gap in the field team lead position there, and I'm helping with some of the publications and things like that. The main paper for STRIVE, I'm helping the principle investigator get that written up, and we're working with Barbara on a lot of things related to getting abstracts submitted, now, for the fall meetings. You have to think now for the fall--it's not so far way--and 02:24:00for a writing workshop that we're going to be having in Sierra Leone in July, and sort of doing those things but starting to transition out so that within the next six months I'll be out and Barbara will be leading. Then I'll retire from CDC, actually, and go and work half-time for the Task Force.

Q: Can you tell me about that? What your future holds?

SEWARD: Yes. I'll be working initially in the Center for Vaccine Equity there, with Dr. Alan Hinman. Alan's an old great from CDC. He was actually director of the Communicable Disease Division of Immunizations, I think it was called. That may not be the exact, correct name, but before NIP was a center, it was an entity that wasn't a center that Alan was director of. Walt Orenstein took over 02:25:00from Alan, and Alan's been at the Task Force for a number of years. I'll be working with him, which will be a great opportunity. Initially, working on a project that looks at vaccines on the shelf, so certain vaccines for use in the developing world, vaccines that get invested in by companies up to a certain point of development and then don't go into human studies, often. Of course, the Ebola vaccine is a perfect example. Ebola vaccine got tested in animals, including up to non-human primate level, was shown to be safe, was shown to one hundred percent effective in preventing Ebola, and two different vaccines reached that level of testing. And then essentially, no further development 02:26:00occurred. For Ebola, there were pretty good reasons for that, because it's challenging--you can't test whether a vaccine works if there's no disease, and it was very hard to tell where disease was going to occur with Ebola. I think companies just weren't prepared to continue development, so those vaccines just sat.

When this epidemic occurred, the US government hosted a lot of meetings in the summer and fall of 2014, WHO hosted a lot of meetings, and there was a decision made. There were two vaccines that were at a good point to hit phase one human trials, and so those were accelerated into human trials in the fall of 2014. That was the first human trials. We were doing a phase two, three, 02:27:00efficacy/safety study in the spring of 2015. It was really unprecedented in how rapidly those things happen, but had those vaccines had more testing in humans, it would have been quicker to put them immediately into a final trial. Or if they'd been developed right up to--there are other ways to get vaccines licensed than if you don't--you can show efficacy, the FDA [Food and Drug Administration] has--for the reasons, like you can't, with Ebola--FDA has some other pathways, alternate pathways, for licensure. One is the animal rule that allows you, if you have efficacy data in animals, a good animal model, especially in non-human primates, and have safety data in humans, safety and immune response data in humans, and some bridging of the immune response in humans to the immune and 02:28:00efficacy response in an animal model, then you can file for licensure without efficacy. For Ebola vaccines, it's really important to keep developing other vaccines because they could get licensed under that rule, without efficacy.

Back to the vaccines on the shelf project, the idea is to do a review of all the vaccines that have reached a certain stage of development but not been further developed, to convene an expert panel and to summarize all the available information--and meet with vaccine manufacturers, meet with experts, and then convene an expert panel, have a meeting and discuss and prioritize vaccines for development that would really benefit from investment and development, and then 02:29:00work to try to make a case, an investment case, for those vaccines. That's what I'll be starting on. I'll be actually starting on it in a reimbursable detail first, for CDC, for the next six months, and then will retire and work for the Task Force.

Q: Thank you for that. You might have already answered this a little bit, but can you discuss a little bit more where the vaccines are now and that possibility of will they just--if Ebola doesn't happen, what'll happen to the vaccine?

SEWARD: That's a great question. We feel really strongly about this, and I think fortunately so do Merck. We haven't worked with GSK [GlaxoSmithKline], we ended up selecting the Merck vaccine for our trial, so haven't worked as directly with GSK, that had the other vaccine. Then there are other vaccines in development, 02:30:00too. J&J, Johnson and Johnson, they're developing one also. I think STRIVE will provide the largest safety database for this vaccine from any study, because we vaccinated over eight thousand people. We feel it's going to provide critical data, and we also have immunogenicity data from five hundred people that will have data out to one year post vaccination, to show some durability of immune response, some information on durability of the immune response. Those will be submitted to the FDA for licensure, from STRIVE. Then NIH would be doing the same with their PREVAIL data, WHO would be doing the same with their ring vaccination data. That all gets submitted to the FDA. The FDA reviews all that 02:31:00information. It's a biological licensure application that Merck makes, or vaccine companies make, to FDA, and based on the data they have, the FDA reviews all the data and makes a decision on licensure.

I think Merck are optimistic they'll be able to file next year. They have some other trials that they're doing on lot consistency. I think one of the real challenges with this vaccine development is usually you do very measured order of vaccine development. First, you might develop the tests that you're going to use in the trial, at the very beginning. They were being developed right at the 02:32:00time everything was done concurrently, here. You would usually do lot consistency studies before phase one. They didn't have time to, so there were a lot of ongoing studies that are being done by the manufacturer. There were studies being done in children because we didn't study the vaccine in children. We only studied in adults. So did NIH. WHO did modify their protocol to go down to age twelve, and then down to age six, but they'll need to go down to one, probably, to do some more work in young children, so that's being done in a number of African countries. Studies in HIV-positive people, who were not included in the trial, not included as a group known to have HIV [human immunodeficiency virus]. NIH tested everybody and then did have some people with HIV that they could look at safety in a small number of people, but there will 02:33:00be trials done in a couple of hundred HIV-positive people. When all that data's available, it will be submitted to the FDA and they'll look. Meanwhile, GSK are doing the same thing and preparing to submit, or submitting, and then other companies are continuing their trials with the same intention.

I think CDC feels it's very important for a vaccine to get licensed. After all this work, all this collaboration, which was absolutely unprecedented, including FDA that reviewed protocols and things in an extraordinarily short time frame than they usually take, it's really important now for people not to take their eyes off this and to keep the focus and get a vaccine licensed. That's certainly 02:34:00the intention. Merck will be submitting, and I assume the other companies will be as well, to see this through to a licensed product. GAVI [Global Alliance for Vaccines and Immunization] has made an advanced market commitment after the ring results came out from Guinea, that they're willing to pay Merck for a certain number of doses immediately after licensure, based on the preliminary results from the Guinea trial with the efficacy data. I think that's very promising. Hopefully, there will be a vaccine available not just for responding to cases, but if there's some information on durability of response, then it would be--I think there are groups that would benefit from vaccination before exposure, especially health care workers. A really high number got infected in this 02:35:00epidemic. In Sierra Leone, the risk was one hundred times greater if you were a health care worker. In one district, 12.5% of the cases were health care workers and a number of them died, including leading experts in Ebola, because they just--they were probably overworked, exhausted, didn't have the equipment they needed for infection control in the early stages of the epidemic. Really tragic. Had they been protected additionally with vaccine, it would have been helpful. You still need those things as well as infection control, because no vaccine's one hundred percent effective, but it's still very, very helpful.

WHO has had a working group looking at priority groups for offering this vaccine. There have been meetings of this Strategic Advisory Group [of Experts 02:36:00on Immunization], SAGE, which is the strategic advisory group to WHO on immunization policy. There's been an Ebola working group that has presented to SAGE, thinking through when a vaccine becomes available, who might they recommend it for. Initially, perhaps high-risk groups, but potentially in the long run, perhaps entire populations. Although, this disease may never occur again in West Africa. We expect it will, but the epidemic is still flaring up. There's still cases occurring from sexual transmission, and perhaps from reintroductions. But could vaccinate the whole population and not see it again ever there. But there's certainly health care workers and others might be at 02:37:00risk in countries where it has occurred, would be important. I think the other important thing to note about vaccine development is that this vaccine is targeting Zaire ebolavirus, and Ebola on the east coast of Africa is not this virus. It's Sudan ebolavirus, and this vaccine likely won't work against that one. There's a need to have multivalent, ideally--like poliovirus, that contains three polioviruses in one vaccine. It could be very beneficial to have a vaccine that protects against the main strains, not just the Zaire strain. I think that it's in development as well.

Q: How do you get to that point, where you can make it multivalent?

SEWARD: You have to test against the different strains. You have to either test individually and then put them together or ideally, put them together and then 02:38:00test. You may not be able to test because there's not Sudan ebolavirus circulating now, so you'd have to be testing for safety and the immune response, then hope to get it licensed through these alternate licensure pathways.

Q: That makes sense. Okay. I have one kind of random question and then a summarizing one. You mentioned to me previously that your daughter-in-law also worked in Liberia for the response?

SEWARD: And Guinea.

Q: And Guinea?

SEWARD: No, sorry. And Sierra Leone! She came when I was there. She works on the lab side. She's a laboratorian working in NCEZID [National Center for Emerging and Zoonotic Infectious Diseases]. She volunteered in the fall of 2014 in Liberia for a lab tour. CDC has had laboratories in both Liberia and Sierra 02:39:00Leone. I think she had a six week--no, four week--deployment in 2014, and was back just before Thanksgiving. That was the height of the epidemic in Liberia. That was when the dead bodies on the streets in Monrovia, and it was just very traumatic. I think she felt very strongly after she did that that it was a very valuable thing, and her branch allowed her to volunteer again. Then she came down to Sierra Leone as a team lead for Bo, for the Bo lab, for four weeks. She flew through Freetown, and I saw her as she came into Freetown, and then it's about a three-hour drive to Bo from Freetown. She spent another four or five weeks in Bo.

Q: What was it like having family as part of it?

SEWARD: Well, we just have a working relationship related to CDC, so when she came through I had dinner with her and we caught up. The lab--I mean, the people working in Bo, we had somebody in Bo as well for STRIVE, to test STRIVE specimens that came through there, because we had people tested for Ebola. We tested forty-eight people for Ebola. None of them had it, fortunately, but they had to be tested using a different test than was used by the CDC lab, and different standards. Initially, we just had to staff somebody there to do it. Bo is a tough rotation. They were pretty much in the lab sixteen hours a day. Hundreds of specimens were coming daily. They had only a team of four or five 02:41:00people, and it was very hot, limited air conditioning, maybe even no air conditioning. Had fans and tried to open the windows, but drank gallons of water, lost weight. Everybody lost weight down there. They'd often get back to the hotel after, they'd miss dinner, and so they'd just have to have something in their room. I think it was much more of a field experience than being in Freetown, staying at the Radisson Blu [Mammy Yoko Hotel], where I stayed most of the time. When she came on either end, on the way back, it was, wow, I can eat lobster or shrimp. [laughs] So yes, it was interesting. She enjoyed--she felt very strongly, too, about her two deployments, that they were very worthwhile. It was a very important mission of CDC, and she was very happy to be able to 02:42:00contribute to it.

Q: Reviewing your participation in STRIVE, can you talk about--well, just reflect on what STRIVE has meant for you?

SEWARD: It's been an amazing experience for me. I think it's probably been the most rewarding experience in my CDC career. I didn't really think about it or anticipate. I just volunteered for a deployment and ended up staying on for fourteen months. It will be eighteen months by the time I leave. If you work in vaccines, which I've done my whole career here at CDC, vaccines prevent disease. There was hardly anything more important in the epidemic, as far as I was concerned, than getting a vaccine licensed for this terrible, terrible disease 02:43:00that had devastated, and is still devastating, West Africa. To be able to contribute to that was an extraordinary opportunity, and I think it ended up being something--I was extremely comfortable in the field. I haven't done a lot of international work since I started at CDC, but I think my years in China made me very comfortable with working with the UN, and I've been at high enough levels in CDC that I know how to work within CDC comfortably. I know who to reach out, how things work, when I needed to talk to Oliver, when I couldn't manage it myself, when I needed country assistance, things like that. Oliver was a fabulously supportive country director. We needed Oliver a lot, and he always, 02:44:00always would answer a phone call, would respond to an email, would meet at eleven o'clock at night and sign the letters to the Ministry designating $100,000 for the renal dialysis unit so we could get the trial started.

It was very, very valuable time. I really enjoyed it. I think it played to my strengths, and I was just very grateful for the opportunity. It was a tremendously fulfilling opportunity. I was glad I was at a point in my family life that I didn't have young children, I didn't have children at home, I could be overseas for the amount of time I was. It was very good of my husband--he was very supportive of that. He could see, also, the importance of this, but six 02:45:00months is a long time. He was a much better cook when I got back. [laughs] For me, it's been--it's certainly been the highlight of my CDC career, and I think there have been a lot of important things I've done for CDC, or I've been able to contribute to. But this, I think, was just an extraordinary opportunity, and I think it's very hard to manage--I think this has come out in many EOC responses--it's extraordinarily difficult to keep things going with deployments. You can have that as part of the engine, but you've really got to have some people that you can put onto things for longer term, or you lose the continuity. 02:46:00Each time I've been back in Sierra Leone or when I'm here working on STRIVE, I draw on my field experience all the time. All the time. "No, we can't put this in the abstract because this is what happened when we did that in the country eight months ago." I don't know how you would function in the capacity without that field experience. It's been very, very valuable to be able to draw on that. Each time I've been back in country, I've drawn on it over and over. You're learning by doing, again, and that's very, very valuable. For me, it's been an extraordinary opportunity to work on something very important, and I've been really glad I could do it and contribute to it, in a small way.

Q: Well, I don't know about small. Do you have any final reflections or anything 02:47:00you want to make sure we get recorded, in the record, looking back?

SEWARD: No. I mean, I think CDC did an amazing job responding to Ebola. I think as an agency we did a tremendous job. STRIVE was just a small part of the overall Ebola response, and we had people--thousands of people--deploying to all the three countries, helping with a lot of other countries too that had importations or had to do a lot of preparedness. Now we're forming these response teams, or people that can be ready to respond and stay in-country for a long time. We had some long-term deployers like Oliver that spent a year in Sierra Leone, Sarah Bennett, another year or longer. Some of those long-term 02:48:00commitments, really, I think helped build--keep that high capacity in all these countries, to be able to do what we did. I think as an agency we should be very proud of the response. Vaccine trials are not CDC's bread-and-butter work, so I think we should congratulate ourselves as an agency for being prepared to take something on that we don't do, usually, and so we had to learn by doing. It was very helpful to have help from BARDA and some of these other agencies in HHS who had the trial experience, but we couldn't just--it took some learning for us, as well. I think as an agency we've got a lot to be proud of for the Ebola response.

Q: Okay. Thank you so much for being here. I've learned so much. It's been a pleasure.

SEWARD: Yes, likewise. Thank you.

END