Issue 22 Jerome Kim, M.D., Director General, International Vaccine Institute (IVI)

November 2020

Director General, International Vaccine Institute (IVI)

Dr. Jerome Kim, our readers know that you are a renowned physician and a recognized leader in vaccine research and development, especially in HIV. What motivated you to attend medical school and become a physician? Also, what events in your career or in life led you to HIV/vaccine research?

My interest in biology and the medical field started in high school, and I was especially fascinated by the field of regeneration. In my AP Biology class, we were given an assignment to write an extensive research paper on regeneration, and then a paper on bronchopulmonary dysplasia, which made me want to work on regeneration. After high school, I went to the University of Hawaii and expressed interest in wanting to work on regeneration.

After graduation, I wanted to attend medical school outside of Hawaii, so I applied to Yale School of Medicine and was accepted. However, my parents made it clear that I should get a scholarship to attend medical school. Upon searching, I found that the military was offering a scholarship program for medical students in exchange for a service commitment, the program still being offered today. Students were required to serve in the military as medical officers after obtaining their medical degrees and had to go through residency in the military in most instances. I signed up for the Air Force scholarship, and the Air Force paid a stipend as well as tuition and books. Towards the end of medical school, I asked to defer my military service to do my residency outside of the military, and they approved. Therefore, I completed my internship, residency, and fellowship at Duke University. During my fellowship in infectious diseases, I worked with Dr. Warner Greene, who is now at the University of California San Francisco, on HIV.

Dr. Kim delivering an oral cholera vaccine to a child in Ethiopia in 2015 (Credit: IVI)

In 1989, I became a faculty member at Duke University Medical Center and received a Pfizer postdoctoral fellowship grant and an NIH grant. Even though I wanted to defer my service for another five years, the first Gulf War had started, and I was activated. I was sent to “back-fill” a vacancy at one of the major air force hospitals. In the military, I was assigned to the Walter Reed Army Institute of Research to work on HIV vaccine research with the Army, and that is how I ended up in the field of HIV vaccine research. My first boss in the Department of Retroviral Research was Dr. Robert Redfield, now Director of the CDC, whom I later joined at the Institute for Human Virology at the University of Maryland after fulfilling my Air Force commitment. After two years of working, Dr. Deborah Birx, the current coordinator of the White House Coronavirus Task Force, reached out to me and invited me to join the Army and do more work on HIV vaccine research. I accepted her invitation and was asked to help with the RV144 Phase III HIV vaccine trial in Thailand, which remains the only vaccine trial that has shown protection against HIV infection. In 2015, I was eligible to retire from the military, and I was asked to join the International Vaccine Institute (IVI) as the Director General.

We understand that the International Vaccine Institute (IVI) is an international organization devoted to vaccine development and delivery for the developing world. Can you please tell our readers more about IVI’s identity and mission?

IVI is a non-profit international organization that was founded in 1997 as an initiative of the United Nations Development Programme (UNDP). The UNDP saw the need for an institute that develops vaccines for global health to fill the gap between the availability of vaccines for developing countries and developed countries. The major vaccine companies are great at making vaccines for diseases found in high-income countries, but not for diseases in developing countries. For many diseases found predominantly in developing countries, there were no vaccines because companies did not find sufficient profit incentive to develop them. Thus, IVI was founded as the brainchild of UNDP to develop vaccines to fill this gap.

IVI is an international research organization. Similar to the WHO, we have signatory countries and state funders. More than twenty five percent of our funding comes from our state funders, which include the Republic of Korea, Sweden, India, and Finland, and the rest comes from grants by organizations such as the Gates Foundation, the Wellcome Trust, and the European Union.

IVI’s operating model is that we identify diseases that have gaps in vaccine development, create a vaccine in our laboratory, work to get funding for the technology transfer of the vaccine to a developing country vaccine manufacturer, test the vaccine in Phase I – III trials, and then work with the manufacturer to get local, and ultimately WHO’s approval. WHO approval, called “prequalification” (PQ) is necessary for vaccines to be purchased by UN agencies and is a further assurance of quality. We can also work with companies interested in doing clinical trials in low and middle-income countries. For example, we are working with Bharat Biotech, a major Indian vaccine manufacturer, to do Phase II/III testing of their chikungunya vaccine in Panama, Colombia, and Thailand.

(Right to left) Dr. Kim with Ban Ki-moon, 8th UN Secretary-General, Minwon Lee, Director General, Center for Public Health Emergency Preparedness and Response at the KCDC; and Ki-Hwan Kweon, Director General, International Organizations Bureau of MOFA Korea, at the IVI State Forum 2019 (Credit: IVI)

Our main goal is to generate vaccines for global health, so our priority is to have the vaccines pre-qualified. In other words, we aim to move vaccines along a development pathway with the end being prequalification, use, and reduction in the burden of disease. IVI also can be viewed as a development organization because we work along the entire spectrum of vaccine R&D; we work not only with vaccines that are being developed, but with vaccines that have been approved to increase their uptake and to generate data in the “real world” that will help to generate good policy. In such efforts, we work with organizations such as WHO and Gavi, the Vaccine Alliance to create stockpiles and recommendations for the use of vaccines because many countries are not aware how significant the burden of these diseases is. In that sense, IVI also helps to generate demand for such vaccines—to get vaccines used to reduce the burden of disease.

IVI’s mission is to discover, develop, and deliver safe, effective, and affordable vaccines for global health. We develop novel strategies on new vaccines that help children in any country receive vaccines for vaccine-preventable diseases.

"We develop novel strategies on new vaccines that help children in any country receive vaccines for vaccine-preventable diseases"

No other organizations occupy the same niche, and we are often asked how IVI is different from Gavi or the Global Fund. The difference is that Gavi and the Global Fund are funders, whereas we are executors or enablers. In our strategy, we choose vaccines based on burden of disease, whether the development is feasible and funding is available, and then assess the impact of having the vaccine available. This strategy has been working; it has created sustainable value for companies and impact for people around the world. This makes us relevant to stakeholders. Also, it means a lot for us to maintain enough capability to function like a small biotech—to have people in the lab for discovery, others to manage clinical development, policy, vaccine delivery, and effectiveness trials for licensed vaccines. Thus, we have to maintain our key capabilities, which means that we have to work in different stages of a vaccine’s life cycle with different diseases of importance to global health.

IVI commemorating the institute’s 22nd anniversary in 2019 (Credit: IVI)

What are the major vaccines that IVI has been working on?

Our first prequalified vaccine is the oral cholera vaccine, and the second is the typhoid conjugate vaccine which currently is in Phase III testing. What we call “Vaccine #3” could be a multivalent non-typhoidal vaccine against Salmonella or Shigella. We will be involved in the testing of vaccines for chikungunya, COVID-19, and HPV, in collaboration with Bharat Biotech in India, Inovio Pharmaceuticals in the U.S., and the Ministry of Public Health in Thailand, respectively. We do not develop vaccines made by large companies that are well-funded and making significant investments, such as the respiratory syncytial virus (RSV) vaccine. Instead, we focus on vaccines that are neglected by the major companies.

In 2000, IVI received a letter from Bill Gates Sr., who recently passed away. His message was written on a single letter that (paraphrasing) said, “We think that IVI is right about the diseases of the most impoverished, here’s $40 million. Please work on vaccines and inform us every now and then about the progress.” It was an incredible grant that jump-started IVI’s work.

IVI began its work by exploring the diseases that bring significant burdens in the developing world, and how we can start to make vaccine solutions against them. Later, IVI received another grant that allowed us to work on a cholera vaccine that was being made by a Vietnamese biotech, called Vabiotech. The vaccine wasn’t at the level to be approved for use by the WHO. Therefore, IVI brought the vaccine in-house, reformulated it to meet the international standards, then transferred it back to Vabiotech and to Shantha Biotechnics. By 2011, the vaccine had not only been approved in India, but it was also pre-qualified by the WHO. This meant that UNICEF could purchase the vaccine and provide it to Gavi, the Vaccine Alliance, with the goals of increasing access to immunization in developing countries and global distribution.

In fact, that was only the beginning. Shantha was not making enough oral cholera vaccine, so we transferred the vaccine to a small Korean company, EuBiologics. Now, this company is the world’s largest supplier of oral cholera vaccine, making up over 80% of the current stockpile. The demand is still skyrocketing because the WHO announced a plan to reduce cholera deaths by 90% and eliminate cholera in as many as 20 countries by 2030.

Dr. Kim with Kang Kyung-Wha, South Korean Foreign Minister discussing the COVID-19 pandemic and equitable access to vaccines in June 2020 (Credit: MOFA Korea)

You formerly served in the U.S. Military as Deputy Director and Chief, Laboratory of Molecular Virology and Pathogenesis at the U.S. Military HIV Research Program (MHRP) and as the HIV Vaccines Project Manager with the U.S. Army Medical Materiel Development Activity (USAMMDA). Could you please share your thoughts on this experience? How did your service affect your professional philosophy?

Something that is not very well-known about the U.S. military is that it is helping the primary development and/or the invention of eight different licensed vaccines, and many fall into the “unincentivized” category. In fact, several major vaccines that are used today originated in or were tested by the military. Examples include the meningitis vaccine, the testing of the hepatitis A and Japanese encephalitis vaccines. Moreover, the vaccine against adenovirus types 4 and 7 was developed by the military because it was causing a critical problem in the military population, particularly among the new recruits. The viruses made a large number of recruits sick and resulted in the death of a few recruits every year, so the vaccine was developed and is still being used today. Also, the famous GSK malaria vaccine started in the Army; more specifically, both the development of the antigen and the adjuvant, which makes the vaccine so effective, originated in the Army through a co-development agreement with GSK.

Thus, the Army’s involvement in vaccine development revolves around neglected diseases, such as dengue, malaria, or HIV; and this closely resembles the work we do at IVI. In developing vaccines such as HIV vaccines that do not have big commercial partners attached to it, the Army model is similar to IVI’s.

IVI finds funding to develop a vaccine and helps to create the use case for it, essentially creating supply and demand. For the Army, that funding comes from the U.S. government and increasingly from outside sources. In the case of IVI, the funding comes from the Gates Foundation or governments of Sweden, India, Finland, and Korea.

The Army’s work is incredibly significant because it’s difficult to get the big companies engaged in neglected diseases. In fact, the Army’s HIV vaccine trial, RV144, showed signs of protection against HIV, but no companies were interested in further trials in Thailand anymore. Therefore, we worked with a small company to find a mechanism to manufacture the vaccine in Thailand; we were not successful in that effort, but it did make me think about the obstacles surrounding vaccines for global health. The Army’s contribution to vaccine development is remarkable, but it is not very well-known.

During the current COVID-19 pandemic, many major health organizations around the world are making enormous efforts to develop vaccines. What efforts, if any, has IVI made to help manage the pandemic?

Currently, IVI is also occupied by COVID-19. Some of our vaccine trials were put on hold because of the lockdown. Governments delayed mass vaccination campaigns and childhood vaccination programs that Gavi is funding all around the world. In fact, the pandemic has also impaired the activities in cholera vaccination.

As for COVID-19, by February 2020, many different companies and research groups had already become interested in developing new vaccines. Therefore, rather than pursue an IVI vaccine, we decided that we would help any company or organization that had a vaccine and needed IVI’s support. I believe that was the right decision.

"Our priority is to have vaccines as quickly as possible, and that is exactly what IVI is doing"

The companies that requested our support were usually smaller companies, and they asked for our assistance in different areas of vaccine development. We were asked to help with animal immunogenicity studies to learn if the vaccine was creating the right immune responses, challenge studies in hamsters or mice, or to help them execute trials in Korea or elsewhere. We gladly accepted those requests, and that has been our approach—we have set up IVI to be an honest facilitator, providing services to support moving many companies’ products more quickly and efficiently.

By not pursuing our own vaccine, IVI chose a product-agnostic approach to COVID-19 vaccine development. Our priority is to have vaccines as quickly as possible, and that is exactly what IVI is doing.

As a trusted expert in the field of vaccines, what are your expectations and concerns regarding COVID-19 vaccine development?

In my opinion, if the current round of COVID-19 vaccine development succeeds, meaning it is shown to be safe and effective against the virus, we should have the initial interim read-outs in November or December of this year.

First Lady of South Korea, Kim Jung-sook with Dr. Kim and Prof. Sang Chul Park at the ‘Shared Future, Global Solidarity’ event where she was appointed as the Honorary President of IVI Korea Support Committee in July 2020

However, just because the vaccines have proven to be safe and effective, it does not mean that COVID-19 is put away for good. In fact, the questions that arise on the day after efficacy would be, “who will make this vaccine in sufficient quantity and when will those quantities be available?” The second question would be, “how are we going to utilize the vaccine?” For instance, Operation Warp Speed, initiated by the White House to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, is designed to take care of U.S. citizens, but what about the rest of the world? Operation Warp Speed has pre-purchased hundreds of millions of doses for the U.S., but where is the commitment for other countries?

Logistics and delivery of vaccines will be a major issue. Do we have the facilities to distribute vaccines that have to be kept at -20°C or -70°C, which is the necessary temperature for RNA vaccine storage? Not only that, how are we going to distribute a vaccine that may be more than 60-70% of the United States population has to take? These days, not that many vaccines are given to adults in the U.S.—maybe the flu vaccines, but not everyone takes them. Thus, even absent vaccine hesitancy, it may be more difficult to deliver vaccines to the adult population than to children.

The countries around the world, typically the high-income countries, have started to purchase large amounts of vaccines for their own populations. For other countries, COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is aiming to provide vaccines. It currently plans to have 2 billion doses by the end of 2021—roughly 20% of the anticipated need. COVAX is important to this, but countries need to step up and provide funding for it. Agreements need to be executed with 190+ countries that have potentially signed on to COVAX, and vaccines need to be purchased, delivered, and given to populations in all countries.

Then, there will be questions around safety. We will know the vaccines are efficacious if they are approved for emergency use, and we will know the safety profile over a short term, such as 6 or 9 months. However, it is crucial that we know their safety over a much longer period, especially in people who were vaccinated early or outside of the U.S. Also, we need to know if the capabilities to identify long term safety exists—the capability to review safety information, to guarantee safety, and to track adverse events related to vaccination. If not, such systems need to be strengthened around the world so that we are aware of unusual developments related to safety, enhanced disease, or worsening of the disease in the third year after vaccination. In fact, these kinds of additional data are necessary because we did not have the luxury to take time to collect the data, conduct trials, or study COVID-19 in depth in just 9 months.

Thus, many pressing questions will arise about the day after efficacy, and they will eventually need to be addressed. In addition, the final question will be around effectiveness, real world evidence, which leads to the question around herd immunity, a concept that occurs when enough people in the community become immune and reduces the spread of the disease.

As a respected physician and scientist with decades of experience, what do you see as the major changes in medicine, vaccines, or HIV studies in the next 10 years? How does this projection affect your work?

The last HIV vaccine efficacy trial, conducted by the HIV Vaccine Trials Network (HVTN), was stopped because it was not able to show protection, as opposed to previous HVTN trials which were stopped because of excess infections in the vaccine group. There is a trial on-going with a Johnson & Johnson HIV vaccine using its Ad26 vector, and I hope that will show some signs of protection. However, what the company plans to do with the vaccines in low and middle-income countries is an open question. There is a tremendous need for HIV vaccines around the world, but many companies are not interested in vaccines purely for use outside of high-income countries. Thus, there is a need for organizations to move forward. Maybe they can consider IVI’s operating model involving developing country manufacturers to make global health vaccines available at a much lower cost and to minimize risk to the larger pharmaceutical companies.

Dr. Kim with his family

HIV medicine/HIV prevention is changing. We now have longer acting prophylactic medication that people can take, which makes it easier to prevent HIV around the world through the use of drugs. There are also novel methods of delivery and broadly neutralizing monoclonal antibodies for new ways to prevent HIV. In fact, monoclonal antibodies have been a remarkable advance in medicine, but their cost is high—tens of thousands of dollars per dose. The challenge is moving this forward in global health because we need vaccines that cost $1 or $2 per dose or are priced according to the cost of HIV care. For that, companies need to be able to manufacture monoclonal antibodies at a lower cost.

Thus, the HIV field is definitely changing, and the non-vaccine strategies are showing promise. However, for all the millions of HIV infected people in this world and for all the infections that are prevented by prophylactic treatment, we have to move forward with whatever works.

Dr. Kim with with IVI’s typhoid surveillance and vaccine effectiveness teams in Antananarivo, Madagascar in 2019 (Credit: IVI)

Dr. Kim, your experience will be a true inspiration to our readers and many in the healthcare industry. Could you please share a message for future physicians and healthcare professionals that wish to pursue careers in medicine?

I think that future physicians and people who want to be physicians should never stop trying to improve the quality of people’s lives, either by treating patients directly under their care or through research in preventing illness or death. For me, research is what always interested me about medicine. I wanted to be in something where I was on the cutting edge, thinking about problems that are able to bring solutions forward, and not everyone wants to do that. As COVID-19 emphasizes, we have hundreds of thousands of dedicated healthcare professionals around the world doing what they do best, which is saving the lives of those who are suffering. We desperately need people who are willing to do that, and we also need people who are willing to come up with the innovative solutions to move forward. IVI’s mission of discovery, development and delivery may enable the world’s most vulnerable people to lead full and productive lives by accelerating R&D for vaccines that confer freedom from vaccine preventable illnesses. That is what motivates the people who work at IVI.

Jerome Kim, M.D.

Director General, International Vaccine Institute (IVI)

Jerome Kim, M.D., an international expert on the evaluation and development of vaccines,

currently serves as the Director General of the International Vaccine Institute in Seoul, South

Korea. He is also an adjunct professor of medicine at the Uniformed Services University of the Health Sciences and a fellow of the American College of Physicians and the Infectious Diseases Society of America. Dr. Kim received his B.A. from the University of Hawaii and his M.D. from the Yale University School of Medicine. Formerly, he was the principal deputy and chief at the Laboratory of Molecular Virology and Pathogenesis at the Military HIV Research Program. Dr. Kim also served as project manager for the HIV Vaccines and Advanced Concepts Evaluation Project Management Offices. He led the Army’s Phase III HIV vaccine trial (RV144), the first demonstration that an HIV vaccine could protect against infection. Throughout his career to date, Dr. Kim has authored over 250 publications and received the John Maher Award for Research Excellence from the Uniformed Services University of the Health Sciences in 2013.

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