We develop vaccines against infectious diseases that are of global health concern (e.g., MERS, Zika) and that affect developing countries (e.g., cholera, typhoid, dengue). Vaccine development and commercialization can be costly, lengthy and fraught with risk, and there are few incentives for companies to pursue development of a vaccine against a neglected disease and/or with a limited market.
IVI bridges the gap by partnering with vaccine manufacturers, governments and philanthropies, and mobilizing resources and funding to develop and license vaccines for the public-sector market. We also drive innovation by transferring technology we develop in-house to companies, and partner with them on clinical testing and production.
In exchange for technology and support, manufacturers make a proportion of their product accessible to the public sector at a low price. As we do not make a profit from intellectual property, we partner with multiple companies on tech transfer, which helps ensure sufficient vaccine supply for the public-sector market.
We brought to market a low-cost oral cholera vaccine that is WHO-prequalified and stockpiled by WHO for emergency use. More than 4 million doses of the vaccine has been deployed to prevent and control cholera in 13 countries. IVI is currently developing vaccines against typhoid and MERS.
The Cholera Program aims to accelerate the development and introduction of oral cholera vaccines against endemic and epidemic cholera through a public-private partnership approach.
Our cholera story dates back to 2006 when IVI reformulated an oral cholera vaccine (OCV). The technology was transferred to manufacturers and IVI partnered with some of them on development and commercialization. Since then, two oral cholera vaccines, Shanchol™ and Euvichol® are WHO-prequalified and available for purchase.
IVI developed the world's first affordable oral cholera vaccine for developing countries
|Shanchol™ (Shantha Biotechnics; part of the Sanofi group), India||
|Euvichol® (EuBiologics), South Korea||
|Cholvax® ( Incepta Vaccine), Bangladesh||
We continue to work on the oral cholera vaccine. A thimerosal-free version of Euvichol® was WHO-prequalified in September 2016. In addition to removing thimerosal from the vaccine, production capacity was scaled up to 25 million doses per year through a new 600-liter fermenter. Even though Euvichol® was prequalified in 2015, these modifications required a second approval by the WHO Prequalification Program.
We also work on optimizing vaccine use. The oral cholera vaccine is administered in two doses over a 14-day interval however a single-dose regimen would be advantageous for outbreaks, refugee camps and other emergency situations. IVI is partnering with icddr,b on a single-dose study in Bangladesh. Subjects were followed up six months after vaccination, showing the single dose is mildly protective for all cholera cases while more protective for severe cholera. Follow-ups will continue to be made at 12 months, 18 months and 24 months.
We support delivery efforts of the oral cholera vaccine. In 2016, one million doses of Euvichol was provided by EuBiologics to Haiti as part of public health efforts to control the outbreak in the country. IVI, with Rotary International and Nepalese health authorities conducted a cholera vaccination campaign in Banke, Nepal with Euvichol, vaccinating about 27,000 people.
We also conduct the Cholera Surveillance in Malawi (CSIMA) project, funded by the Bill & Melinda Gates Foundation (BMGF). CSIMA aims to establish a cholera surveillance platform in two districts of Malawi to assess effectiveness of the oral cholera vaccine following an emergency vaccination campaign in early 2015. This evidence will be useful to funders, policymakers and countries who have cited the need for more data on use of the vaccine in real-life situations to support decision-making on vaccine introduction.
The Typhoid Program aims to accelerate the development and introduction of new-generation typhoid vaccines in two ways: 1) development of new typhoid conjugate vaccines in collaboration with manufacturers; and 2) generation of evidence on the burden of typhoid in Africa.
We developed a typhoid conjugate vaccine using technology from U.S. National Institutes of Health, conjugating the Salmonella Typhi Vi polysaccharide to diphtheria toxoid (Vi-DT). The new vaccine has the advantage of conferring protection in infants (a high-risk group) against typhoid. IVI transferred the technology to SK Chemicals of South Korea and Biofarma of Indonesia and is working with them on preclinical and clinical development for vaccine licensure and WHO-prequalification. More recently, IVI started a partnership with Incepta Vaccine of Bangladesh to develop the Vi-DT vaccine. Other typhoid conjugate vaccines are on the market and IVI will work with the manufacturers on getting their vaccines WHO-prequalified to ensure the vaccine is globally available and accessible.
In 2016, work continued on Vi-DT vaccine development. In particular, the phase I trial for SK Chemicals’ vaccine candidate was initiated in the Philippines, a major milestone in the vaccine’s clinical development pathway.
One of the major findings…is confirmation that enteric fever caused by S. Typhi and non-typhoidal Salmonella is a significant problem in Africa.
We conduct epidemiologic and socio-economic research of typhoid in Africa in order to close the knowledge gap on disease burden in the continent. While typhoid is recognized as a public health problem in Asia and Africa, information on its true burden is lacking, making it difficult to justify vaccination policy and to assess the impact of typhoid vaccination.
From 2011 to 2015, we conducted the Typhoid Fever Surveillance in Africa Program (TSAP), which evaluated the typhoid burden through standardized surveillance at 13 sites in 10 sub-Saharan African countries. One of the major findings of TSAP is confirmation that enteric fever caused by S. Typhi and non-typhoidal Salmonella is a significant problem in Africa. IVI launched a follow-on study, Severe Typhoid in Africa (SETA) in 2016 to assess severe disease outcomes of invasive Salmonella infections and its economic burden at several sites in Africa.
IVI is the lead agency for the Global Dengue & Aedes-Transmitted Diseases Consortium (GDAC), a consortium of four partners – IVI, the International Vaccine Access Center (IVAC) at Johns Hopkins University, Sabin Vaccine Institute, and the Partnership for Dengue Control (PDC) at Fondation Merieux.
GDAC aims to promote data generation and synthesis, accelerate innovations in research, and support implementation of new and existing tools…for comprehensive prevention and control measures for Aedes-transmitted diseases including dengue, Zika, yellow fever and chikungunya.
GDAC aims to promote data generation and synthesis, accelerate innovations in research, and support implementation of new and existing tools. Each partner has specific areas of expertise: IVAC focuses on health economics, strategic demand forecasting and vaccine development; Sabin focuses on communications and advocacy; PDC focuses on integration of vaccine and vector control, diagnostics, clinical case management, and pathogenesis. Besides leading the consortium, IVI is responsible for disease burden and epidemiology, laboratory testing, modeling, policy and access, and regulatory issues.
GDAC was created in August 2016 by joining the Dengue Vaccine Initiative (DVI) with the Partnership for Dengue Control, with the intent to expand the mission from dengue vaccines to a broader scope encompassing comprehensive prevention and control measures for Aedes-transmitted diseases including dengue, Zika, yellow fever and chikungunya.
Specific projects by DVI continue to be conducted with support by the Bill & Melinda Gates Foundation. These projects include dengue burden field studies in Africa, Asia and South America, support for national regulatory authorities (NRAs) reviewing dengue vaccine candidates, and convening of dengue prevention board meetings to address key issues in prevention and control of Aedes-transmitted diseases. Other GDAC activities include the development of a centralized database for clinical trials of the U.S. NIH dengue vaccine candidate conducted by sub-licensees of the NIH dengue vaccine. Efforts are being made to obtain additional funding for proposed GDAC activities, with a focus on integrated vaccine/vector control.
IVI continued to make progress in dengue in 2016, through DVI and subsequently, GDAC, by conducting disease burden field studies in multiple countries, and supporting activities to increase readiness of low- and middle-income countries to introduce dengue vaccines, particularly in light of the recent licensure of Sanofi Pasteur’s CYD-TDV vaccine (Dengvaxia®).
IVI launched the MERS Program in late 2015 with funding from Samsung. The five-year grant will accelerate the development of MERS vaccines, with the aim of having two MERS vaccines demonstrated to be safe and immunogenic in Phase II trials conducted in South Korea, and that can be deployed in clinical efficacy trials at possible outbreak sites.
IVI will partner with two vaccine manufacturers on early-stage clinical development of their MERS vaccine candidates by providing technical and financial support, as well as support in project management and coordination.
the number of articles published
in peer-reviewed scientific journals
Scientific Citation Index (SCI) journals
A global cholera vaccine stockpile, managed by WHO, was created in 2013 using the oral cholera vaccines developed by IVI. The stockpile created a market for oral cholera vaccines, which did not exist before. It is estimated >4 million doses of the vaccine have been deployed in epidemic and endemic situations in 12 countries so far (India, Bangladesh, Ethiopia, Malawi, Iraq, South Sudan, Haiti, Tanzania, Cameroon, Guinea, Nepal, and Democratic Republic of Congo).
Globally, OCV production was low, with demand exceeding supply. The WHO had to turn down requests from countries for supplies of vaccines that could not be filled because of the shortage.
That all changed in December 2015 when Euvichol® was approved by the WHO Prequalification Program. The addition of another cholera vaccine producer is expected to double global supply to 6 million doses for 2016, with potential for further increased production in the future. More importantly, the extra capacity will contribute to reversing the cycle of low demand, low production, high price and inequitable distribution to one of increased demand, increased production, reduced price and increased access.
While supply has increased, there is room for improvement in uptake of the vaccine. Funders, policymakers and countries have cited the need for more advocacy and evidence on use of the vaccine in real-life situations to support decision-making on vaccine introduction.
Established in 1998, the KSC is an independent nonprofit organization that mobilizes support for IVI in South Korea. The Committee consists of prominent leaders from government, industry, and academia in South Korea.
|Bill & Melinda Gates Foundation (BMGF)||15,205,867||12,380,328|
|Government of the Republic of Korea||4,813,476||3,631,659|
|Swedish International Development Cooperation Agency (Sida)||780,368||720,420|
|Corporations / Individuals / Others||5,149,713||3,095,397|
|Korean Government Laboratory Support||-||1,294,612|
|Investments (Interest Income)||112,108||35,005|
|Management & General||2,223,861||3,081,691|
|Communications & Advocacy||608,234||831,373|
|Foreign Exchange Gain (Loss)||179,765||(480,939)|
|Net Surplus (Deficit)||1,211,643||(1,158,141)|
|Cash and Cash Equivalents||5,676,076||5,126,466|
|Other Current Assets||763,775||1,031,521|
|Liabilities and Net Assets||2015||2016|
|Grant Funds-Deferred Support||15,803,851||23,079,592|
|Other Current Liabilities||2,734,583||1,843,335|
|Total Liabilities and Net Assets||23,484,429||28,657,279|