IVI News

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Press release by the Ministry of Health and WelfareThe Ministry of Health and Welfare said it held on September 12 a seminar ‘Partnerships in Global Health R&D’ to help assist acceleration of the Korean pharmaceutical industry’s advance into the global new drug and vaccine markets. The global vaccine market is growing robustly at an annual rate of 11 percent since 2010 and expected to reach 114.2 trillion won in 2023 (GB Research), while the Korean vaccine market, which was worth about 700 billion won in 2014, is also fast expanding at an annual rate of 8 percent. The ratio of domestic vaccine supply relative to domestic needs only amounts about 39 percent as of 2016 (based on the type of vaccines), while the nation’s vaccine export only came to 232.7 billion won as of 2015. The market for drugs considered as essential public goods is also projected to grow at an annual average rate of 5 percent to 10 percent, primarily in the Asia-Africa (including Australia) and Latin America (Europe: 1~4%, Japan -1~2%) regions. As such, it is urgently necessary (for Korea) to make investment in development of vaccines and new drugs through strategic alliances with international organization(s) with experience in technology and entry into markets, and network with various health authorities of different countries. Through today’s seminar, the government, international organization(s) such as the Bill & Melinda Gates Foundation and IVI, and Korean companies discussed ways of global private-public partnerships aimed at accelerating investment in vaccines and new drugs and access to the global market. Notably, the Japan Global Health Innovative Technology (GHIT) fund model was explained in details, which was followed by in-depth discussions about the establishment of a private-public fund in the form of a matching fund, and about a model of cooperation with non-profit international organizations that assists individual companies, and the entire process ranging from R&D to access to the global market. Vice Health and Welfare Minister Bang Moon-kyu said, “If a ‘Korean style global private-public partnership fund is launched,’ it will not only be able to accelerate development of global vaccines and drugs, and development of related industries, but also to improve the national image through expansion of humanitarian assistance to the public sector vaccine and pharmaceutical market.” He added, “Since officials from the Gates Foundation, IVI and Korean companies have gathered today, I hope that the formation of Korean GHIT be materialized in the near future.” In her congratulatory remarks, Rep. Park In-sook of the ruling Saenuri Party said, “Attention and alert is increasing on infectious diseases of developing countries due to climate change and increased overseas travels, with cholera cases reported in Korea for the first time in 15 years,” adding, “If Korean companies seeking to access the global market can contribute to improving global health and enhance the nation’s international stature through cooperation with international organizations, it will be a smartest strategy for development of the health industry.” In interviews, IVI Director General Jerome Kim, and Andrea Lucard, Vice chief of MMV, said, “We are aware of benefits that global private-public partnerships provide us” stressing, “We hope to see keen attention and proactive participation by Korean companies with potential and the government.” Lee Dong-wook, director-general of the health industry policy at the ministry, said, “Today’s seminar is a follow-up measure for the comprehensive development strategy for the health industry (2016-2020), which was announced on September 9,” adding, “The launch of a Korean style private-public partnership will be the key to achieving the goal of developing 17 global new drugs by 2020,” adding, “When considering the trend of the public sector vaccine market as an emerging market, and unprecedentedly strong interest in Korea from overseas research funds and international organizations including the Gates Foundation, now is the right timing for investment,” urging keen attention and active participation by interested parties in Korea and overseas.
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A report from a World Health Organization (WHO) consultation convened on 10-11 December 2015 to develop a roadmap for MERS-CoV research activities was published in Nature Medicine. The meeting gathered leading experts and stakeholders from around the world, including IVI Director General, Jerome Kim, one of the co-authors of the report.The emergence and persistence of MERS-CoV in recent years highlights the need for the rapid development of effective interventions such as diagnostic, prophylactic and therapeutic products. In the aftermath of the 2014-’16 Ebola epidemic and the current Zika virus outbreak, it has become clear that more strategic investments are needed in the early development of interventions against pathogens of pandemic potential. With this in mind, the WHO is developing a blueprint for emergency R&D to prevent the impact of infectious disease outbreaks. MERS-CoV is one of the eight pathogens prioritized in the WHO blueprint and was selected as a case study to assess how research and product development activities could be better supported and coordinated.The report summarizes major topics of discussion at the consultation that included baseline assessment and current knowledge about MERS-CoV epidemiology; diagnostic assay development and standardization; therapeutics; and vaccines. A research and product development roadmap for MERS-CoV was drafted; and priority activities were developed and will be further developed in consultation with funders and stakeholders.In summary, global coordination in response to outbreaks has improved since the Ebola epidemic and there are preclinical candidates in the pipeline for MERS-CoV interventions. However MERS-CoV products will have to be developed more quickly, requiring greater investments by multiple funders for development, manufacturing, preclinical and clinical testing, and efficacy testing in affected populations. Therefore, funders and stakeholders must develop a strategy on how to best target their investments in anticipation of future outbreaks.Read it here:http://www.nature.com/nm/journal/v22/n7/full/nm.4131.html  
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In an editorial published in The New England Journal of Medicine, IVI Director General Jerome Kim looks at the challenges and possible solutions   In a recent issue of The New England Journal of Medicine, IVI Director General Jerome Kim considers an accelerated pathway for vaccine approval. Dr. Kim’s editorial follows the publication of a research article in the same journal regarding the immunogenicity study of a meningococcal B vaccine (4CMenB) used during an outbreak of Neisseria meningitides serogroup B at a U.S. university. Regulatory approval and clinical use of vaccines for pathogens causing outbreaks has always been challenging. In the case of MenB vaccines, proving clinical efficacy has been difficult due to the substantial genetic diversity of the pathogen and the decline of meningococcal disease in countries where the burden is well understood. Yet there have been several outbreaks at U.S. universities from 2009-’15 resulting in 43 cases and 3 deaths. Since no MenB vaccine was approved at the time of the outbreaks, chemoprophylaxis was the main intervention. Therefore, a U.S. university outbreak of serogroup B meningococcal disease presented an opportunity to test a multicomponent meningococcal serogroup B vaccine (4CMenB) that had been approved in Europe and Canada on the basis of laboratory biomarkers of efficacy. There was also evidence that the vaccine could provide protection against the outbreak strain. The study showed that 4CMenB induced a response to certain MenB strains but induced a lower response rate against the outbreak strain in the vaccinated students. While it is difficult to conclude if vaccination had a positive effect on the outbreak, the vaccine did induce bactericidal antibodies against the outbreak strain and was safe. Based on these findings, 4CMenB and another MenB vaccine (MenB-FHbp) were approved by the U.S. FDA in 2015 through an accelerated approval process intended for treatments for serious or life-threatening diseases. The vaccines were approved for use in persons 10-25 years old with the caveat that post-marketing studies be conducted to confirm effectiveness against MenB strains endemic in the U.S.. With this case study in mind, Dr. Kim’s editorial points out that for a relatively uncommon but life-threatening disease such as MenB, the regulatory approval of a vaccine in the absence of ideal data may be necessary and appropriate if the vaccine is used in the context of a public health response and if there is commitment to generating additional data for its use. More importantly, he argues the accelerated pathway for product approval should extend to vaccines against pandemic threats and limited outbreaks (e.g., Zika virus, MERS-CoV). By doing so, this could help accelerate emergency R&D to prevent or mitigate the impact of infectious disease outbreaks, ultimately saving lives and minimizing socioeconomic disruption. Read it here:http://www.nejm.org/doi/pdf/10.1056/NEJMe1606015  
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IVI at International Scientific Expert Meeting on Typhoid Fever in Madagascar-SAPORT (Scientific Advisory Process for Optimal Research on Typhoid) meeting convened typhoid experts to optimize typhoid research in Africa and Asia -IVI is leading research on assessing severe typhoid in Africa through Severe Typhoid in Africa Program (SETA) The following is an article translated from French and published in a local newspaper in Madagascar on 31 May 2016 (Midi Madagasikara no.9963 du Mardi 31 Mai 2016). A group of scientific experts on typhoid fever (known as the Scientific Advisory Process for Optimal Research on Typhoid; SAPORT) held a meeting on 25-26 May 2016 at the Carlton Hotel Madagascar to discuss optimizing typhoid fever research in Africa and Asia. Forty scientists attended the meeting, and included Dr. Anita Zaidi of the Bill & Melinda Gates Foundation which funded the meeting; Dr. Adwoa Bentsi-Enchill of the World Health Organization (WHO); and Prof. Robert Breiman of Emory University which coordinated the meeting. The International Vaccine Institute (IVI) and Sabin Vaccine Institute (SVI) were represented, as well as representatives from universities, research institutes and laboratories of six African countries (Ghana, Burkina Faso, Democratic Republic of Congo, Ethiopia, Nigeria and Madagascar) and three Asian countries (Nepal, Pakistan and Bangladesh). They actively participated in the meeting with the goal of harmonizing typhoid fever research in Africa and Asia.In Madagascar, the Ministry of Public Health gave its approval to conduct typhoid fever research in primary health centers and public hospitals (Authorization No. 045-MSANP / EC of 6 May 2011). More than 3,000 blood samples collected from febrile patients were cultured at the microbiology laboratory of the University of Antananarivo during two phases of research (2011-2013 and 2014-2015), which helped detect the presence of Salmonella Typhi in Madagascar. While results from the first phase of research indicated a moderate burden of typhoid fever in Madagascar (Typhoid Fever Surveillance in Africa Program (TSAP) published in Clinical Infectious Diseases, Volume 62, Supplement 1, 15 March 2016), the second phase exhibited a higher number of blood culture-positive Salmonella Typhi cases among the study-enrolled febrile patients in 2015. The Bill & Melinda Gates Foundation is funding typhoid research through two major programs for two years (2016-2018): “Severe Typhoid in Africa Program (SETA)” coordinated by Dr. Florian Marks of IVI and “Enteric Fever in Asia Project (SEAP)” coordinated by Dr. Denise Garrett of Sabin Vaccine Institute. Blood culture is one of the proven diagnostic measures of typhoid fever. Clinical symptoms are multiple but primarily manifest in fever (above 37.5C), and often accompanied by headache and respiratory and digestive symptoms. Handwashing, food hygiene, safe drinking water and elimination of open defecation are some of the key preventive measures until vaccination is ultimately introduced based on considerations by policymakers. 
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In-Kyu Yoon, IVI’s Deputy Director General of Science and Director of the Dengue Vaccine Initiative (DVI) was a guest on Arirang TV’s current affairs talk show “Upfront.” He and Prof. Woo-joo Kim of Korea University discussed emerging global infectious disease threats and how Korea's vaccine industry can help address today’s global health challenges. View the episode here:http://bit.ly/1RKuZrq  
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The IVI/icddr,b study demonstrating that the single-dose oral cholera vaccine may be sufficient to protect older children and adults from cholera was recently featured in SciDev.Net, a news agency focused on science and technology for global development.http://www.scidev.net/south-asia/disease/news/single-dose-oral-cholera-vaccination-is-cost-effective.html  
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Donor Spotlight: Lee Sang-hee & Friends-Long-time IVI supporter and violinist Ms. Lee Sang-hee featured in the major Korean daily, JoongAng Ilbo-Ms. Lee has been holding IVI charity concerts with her students for 12 years, raising close to $100,000-Two Lee Sang-hee & Friends concerts in August and November this year Below is an English translation of the JoongAng Ilbo article published on May 11, 2016.http://m.media.daum.net/m/media/culture/newsview/20160511010804671   ‘I will continue performances to help others until the last day I can move my fingers’- Lee Sang-hee continues holding charity concerts for 12th year to support vaccines for developing countries- Targets 100 million won in cumulative donations in August 2016; ‘we will promote value of life-saving vaccines’  Lee Sang-hee and Friends at ‘Lee Sang Hee Violin Recital with IVI’ Violinist Lee Sang-hee’s performances are ‘life-saving jabs.’ She has continued holding charity concerts for 12 consecutive years, and donated the entire proceeds to IVI. IVI is a non-profit international organization that develops and deploys vaccines against infectious diseases such as cholera. The cumulative total of donations through Lee Sang Hee Violinist Recital with IVI’ amounts to about 88 million won. Lee aims to surpass 100 million won through the upcoming concert in August. “I wanted to inform audiences of how important a drop of vaccine is to saving lives, and to mobilize and amass pennies to help children in developing countries.” She told the reporter in an interview in Seoul on May 6. She said, “I decided to offer a benefit concert upon hearing for the first time stories about children who are suffering from infectious diseases while participating in an event as performer at an IVI donation event in 2004.” After graduating from Sunhwa Middle and High Schools of Arts in Korea, she graduated from the Paris National Music Academy of Excellence (Conservatoire National Superieur Musique De Paris) in France with honors. She currently is teaching at Chung-Ang University graduate school, Sangmyung University, and Sunhwa schools. She married in 2006 and has a three-year-old daughter. She started holding concert alone initially, but since 2007, has been holding joint performance in collaboration with ‘Lee Sang Hee & Friends.’ While studying in France, she formed the ensemble ‘Uni Song’ with fellow students from Korea, and held concerts to help a Korean adoptees organization for seven years. These days, she is also holding charity concerts at hospitals, orphanages, correctional houses, and welfare facilities for single moms. She says her philanthropy was due to influence from her parents. “When I was young, my father, a businessman, would take me to orphanages, present dolls to children, and play with them. My father told me to ‘use your talent to benefit the world.” ‘Lee Sang Hee & Friends’ started with five members, but now has more than 30. “My students’ families and friends, and their friends joined us. There is no restriction in terms of age or performing skills. It is our (warm) heart that we want to convey and communicate onstage to audience members.” There are members from all walks of life, ranging from 10-year-old pianist, to a performer close to age 70. Musical instruments include cello, flute, viola, clarinet, and others. All of the members, including a middle-school student who donated her ‘piggy bank’ from monthly allowances and a student who got into medical school to become doctor’ as a result of her activities for the concert, joined hands to help me.” In the beginning, it was not easy to sell tickets for 600 seats in a concert hall. But she was able to expand her audience by performing popular songs, in addition to original classical music. “I wish to continue staging concerts to help others until the last day I can move my fingers,as well as now.” “Lee Sang Hee Violin Recital with IVI’ will take place at 2 p.m. on August 27 at Youngsan Arts Hall in Seoul. Tickets are priced at 10,000 won to 30,000 per seat.
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"Developing cholera vaccine in South Korea: IVI Director General Jerome Kim shares stories behind Euvichol, Korea’s first oral cholera vaccine" In the weekend edition of The Korea Herald is a full-page article on how IVI developed Euvichol, the oral cholera vaccine, in collaboration with EuBiologics. Euvichol was prequalified by the World Health Organization (WHO) in December, 2015. The availability of Euvichol will help double the global supply of oral cholera vaccines, which means more low-income countries will have access to this potentially life-saving vaccine.bit.ly/1SLOqWm  
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Dr. In-Kyu Yoon on Yonhap News about Zika IVI’s Dr. In-Kyu Yoon, Deputy Director General of Science and Director of the Dengue Vaccine Initiative, sat down with a reporter from Yonhap News to answer questions about Zika, which is causing concern in South Korea. Dr. Yoon, who has spent years studying flaviviruses like dengue and Zika, is among the few Zika experts in South Korea. Read the English translation of the interview below. The original Korean-language article can be accessed here: http://bit.ly/1Tkswto     "Probability of Zika virus spreading immediately in Korea very low""Dengue outbreak in Yoyogi Park in Japan provides an example" "When conditions are met over time, it is uncertain what will happen" 5 February, 2016 "The probability of Zika immediately spreading in Korea is very low. However, it remains uncertain what will happen over a period of time and if conditions are met." Dr. Yoon In-Kyu, Director of the Dengue Vaccine Initiative (DVI) at the International Vaccine Institute (IVI), is a Zika virus expert in South Korea. In an interview with Yonhap News at IVI on February 4, Dr. Yoon repeated "It is uncertain” several times. He said, "It is because adequate studies have not been conducted yet." Zika virus generally causes mild febrile illness. Signs and symptoms also entail rash and conjunctivitis. The reason Zika is worrisome to the general public is the risk of microcephaly (abnormal smallness of the head) in the newborn when a pregnant woman gets infected. Dr. Yoon said, "The link between microcephaly, which can have an immense impact on a person's life, and the virus is suspected and currently being clarified, and its link with Guillain-Barre Syndrome or other syndromes requires further investigation," adding, "It is premature to decisively judge the risk of the virus at this time." However, Dr. Yoon said that based on facts and findings elucidated already, there is a possibility of the virus spreading in Korea. "This is because we cannot rule out the possibility that a person infected with Zika enters South Korea, is bitten by the Aedes albopictus mosquito vector, and transmits it to another person." Dr. Yoon said the chance that these conditions will happen in the short term is extremely low, but he warned the virus could spread in South Korea during the course of similar situations repeating amongst many people over a longer period of time such as 1 year or even 10 years. For example, Dr. Yoon described a similar case that occurred in Japan in 2014. A dengue outbreak involving more than 70 infected people occurred in Yoyogi Park in central Tokyo, the epicenter. It was the first time in 70 years that dengue transmission occurred in Japan. The Japanese authorities shut down the park for 57 days. The virus that causes dengue is a 'flavivirus,' which is the same kind as Zika. The genetic sequences between the Zika virus and dengue virus are about 70 percent identical. The mosquitos that transmit the two viruses, Aedes (Stegomyia) albopictus and Aedes aegypti, are the same as well. Dr. Yoon said "Emerging diseases including Zika, dengue and chikungunya are increasingly spreading in terms of number of patients and geographical scope," adding, "We cannot predict for certain, but the probability of rapid spread is likely to increase over time." He went on to say, "Changes including the development of better mosquito control techniques may help prevent such a situation from becoming a reality in the future." "There is a long way to go in the quest to develop a Zika vaccine. Although dengue - for which a vaccine has been developed - and Zika both belong to the flavivirus group, we need to first analyze the characteristics of Zika virus. But the reality is research findings are still limited at this time." For example, studies are needed to check whether a person with a history of dengue infection would develop immunity to Zika, or would symptoms be aggravated when a person is infected with Zika. While the world’s first dengue vaccine is available - developed with cooperation from IVI - and is licensed in several countries, some questions remain on its efficacy. IVI, of which Dr. Yoon is currently affiliated, is a non-profit International Organization headquartered in Seoul, South Korea. The Institute was established as an initiative of the United Nations Development Programme with the mission to discover, develop and deliver safe, effective and affordable vaccines for global public health. Dr. Yoon is a Korean-American. A graduate of Yale University with magna cum laude, he obtained his medical degree from New York University of School of Medicine. He served as a medical officer with the U.S. military, and has been engaged in public health research at military hospitals and research centers. In the late 1990s, he was stationed at the U.S. military hospital in Yongsan, Seoul. Dr. Yoon said, smiling, "I am not comfortable speaking Korean, but I can hear and understand the language." In the interview, the reporter asked questions in Korean, and Dr. Yoon answered in English. Dr. Yoon is considered a flavivirus expert. His group recently detected the presence of Zika virus in Thailand and the Philippines. He said, "Since I have been continuously doing research in public health, and IVI’s mission is to develop and introduce vaccines for developing countries, that was very attractive to me; hence I chose to join IVI," adding, "Even if IVI was not based in Korea, I would have joined IVI but it is true that IVI’s base in South Korea was very attractive to me as well."
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Major exciting developments are in store for the organization. In 2015, IVI underwent a strategic renewal in which core capabilities were re-evaluated and organizational direction was redefined, with support from the Boston Consulting Group (BCG). As a result, IVI is in a much stronger position to deliver on our core mission due to the following changes: Revised mission statement to reflect our expanded focus on new and emerging diseases of global health importance such as MERS: Discover, develop, and deliver safe, effective and affordable vaccines for global public health. Articulation of a clear strategic direction that builds on our best-in-class product development and translational capabilities. Renewed focus on diseases where we have exceptional expertise and experience, including cholera, typhoid, dengue, hepatitis E, and MERS. A reorganized scientific lab structure designed to facilitate cross-departmental communication and to focus talent against highest priority activities. Streamlined core cost structure that ensures financial sustainability and operational efficiency. Strengthened relationships with funders, PDP partners and Developing Country Vaccine Manufacturers (DCVMs) that ensure that IVI will remain at the forefront of efforts to develop affordable vaccines with global, Asian and African public health importance More information will be issued soon describing in more detail IVI’s new strategy, organization, and focus on cutting-edge vaccine development and delivery. The new team and new direction will help make IVI a stronger organization to deliver greater impact in global health.