The Euvichol story - Development and licensure of a safe, effective and affordable oral cholera vaccine through global public private partnerships

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cholera 104 Title: VaccineThe Euvichol story – Development and licensure of a safe, effective and affordable oral cholera vaccine through global public private partnershipsLina OdevallDeborah HongLaura DigilioSushant SahastrabuddheVittal
cholera 769 estimated to cause disease in more than 2.5 million people and kill almost 100,000 annually. An oral cholera vaccine (OCV) has been available globally since 2001; the demand for this vaccine from affected countries
cholera 3079 complicated, making vaccination programmatically challenging in resource-limited settings.A vaccine against cholera is an example of a vaccine that was facing these challenges. Cholera is an acute, rapidly-dehydrating
cholera 3279 rapidly-dehydrating diarrheal disease transmitted through water or food contaminated with the bacteria Vibrio cholera e O1 and O139. It is a disease of poverty primarily affecting people living in areas with difficult access
cholera 3546 sanitation [2]. The incubation period is between 12 h and five days and if not treated properly, a cholera infection can lead to death within hours.Cholera occurs both as endemic disease and in outbreaks, which
cholera 3719 endemic disease and in outbreaks, which can include large, explosive epidemics. The global burden of cholera is not fully known because of under-reporting, with some affected countries not reporting cases at all
cholera 3937 avoid the stigma often associated with the disease and its economic impact. In 2015, a total of 172,454 cholera cases and 1304 deaths were reported to the World Health Organization (WHO) by 42 countries [2], but
cholera 4174 significant underestimation. A recent study estimates approximately 1.3 billion people are at risk for cholera in a total of 69 endemic countries, and 2.86 million cholera cases occur annually in these countries.
cholera 4237 1.3 billion people are at risk for cholera in a total of 69 endemic countries, and 2.86 million cholera cases occur annually in these countries. Among these cases, there are an estimated 95,000 deaths. Most
cholera 4456 global burden is in sub-Saharan Africa (60%) and South-East Asia (29%) [3].The first vaccine against cholera , a whole-cell (WC) injectable vaccine, was developed in 1885. Although several additional injectable
cholera 4565 a whole-cell (WC) injectable vaccine, was developed in 1885. Although several additional injectable cholera vaccines were developed in the late 19th and early 20th century, they were shown to be reactogenic with
cholera 4769 reactogenic with limited efficacy and unsuitable for large scale public health programs. Vaccination against cholera was eventually removed by the WHO from recommended cholera-control measures in 1973 [4]. It was not
cholera 4828 public health programs. Vaccination against cholera was eventually removed by the WHO from recommended cholera -control measures in 1973 [4]. It was not until 2001 that the first oral cholera vaccine (OCV), developed
cholera 4908 WHO from recommended cholera-control measures in 1973 [4]. It was not until 2001 that the first oral cholera vaccine (OCV), developed at the University of Gothenburg, Sweden and licensed in 1991 (Dukoral®, Crucell)
cholera 5177 purchase by United Nations procurement agencies.However, despite the availability of a WHO-prequalified cholera vaccine, OCV demand remained low. The main reasons for low demand were probably the price (one dose
cholera 5426 sector), and the requirement of coadministration with buffer as the vaccine contains a recombinant cholera toxin B subunit sensitive to the acidic environment in the stomach. While Dukoral has been used in emergency
cholera 5712 vaccine remained mainly a travelers’ vaccine, used by people from industrialized countries going to cholera -endemic areas and not accessible to populations really in need. In spite of the high burden of cholera
cholera 5815 cholera-endemic areas and not accessible to populations really in need. In spite of the high burden of cholera disease, the relatively low demand for OCVs has made producers hesitant to invest in the production
cholera 5926 disease, the relatively low demand for OCVs has made producers hesitant to invest in the production of cholera vaccines which long kept cholera vaccines in a “vicious cycle” of high unit costs and inadequate
cholera 5959 for OCVs has made producers hesitant to invest in the production of cholera vaccines which long kept cholera vaccines in a “vicious cycle” of high unit costs and inadequate supply for the public-sector market.
cholera 6308 International Vaccine Institute (IVI) initiated efforts to develop a safe, efficacious and affordable cholera vaccine in 1999.Fig. 1Desired virtuous cycle of supply-demand for cholera vaccines. A virtuous cycle
cholera 6382 efficacious and affordable cholera vaccine in 1999.Fig. 1Desired virtuous cycle of supply-demand for cholera vaccines. A virtuous cycle of supply-demand for cholera vaccines can be reached by an increased demand
cholera 6438 1Desired virtuous cycle of supply-demand for cholera vaccines. A virtuous cycle of supply-demand for cholera vaccines can be reached by an increased demand (achieved through for example disease burden estimates
cholera 7170 affordable OCVs and working together with many other stakeholders shape the demand for affordable oral cholera vaccines globally. With a focus on IVI’s partnership with the South Korean company Eubiologics, we
cholera 7430 partnerships to facilitate the development and production of a vaccine for a neglected disease like cholera . By mobilizing resources and political will, creating commercial incentives, and building public- and
cholera 8453 technology transfer.Through the Cholera Vaccine Program, IVI aims to reduce the global disease burden of cholera by accelerating the development and delivery of affordable oral cholera vaccines against epidemic and
cholera 8525 the global disease burden of cholera by accelerating the development and delivery of affordable oral cholera vaccines against epidemic and endemic cholera, and to make them accessible to populations at risk.For
cholera 8571 accelerating the development and delivery of affordable oral cholera vaccines against epidemic and endemic cholera , and to make them accessible to populations at risk.For a schematic description, showing the major partners
cholera 9018 NGOs and public-sector IVI can catalyze the development, production and licensure of affordable oral cholera vaccines and accelerate the introduction of theses vaccines to the global market. This figure represents
cholera 9494 milestones in the development of Cholera vaccines.1894–1960•Development of several injectable whole-cell cholera vaccines1980s•Monovalent killed whole-cell oral cholera vaccine developed at University of Gothenburg,
cholera 9552 vaccines.1894–1960•Development of several injectable whole-cell cholera vaccines1980s•Monovalent killed whole-cell oral cholera vaccine developed at University of Gothenburg, Sweden•Technology transfer from University of Gothenburg
cholera 9700 Gothenburg, Sweden•Technology transfer from University of Gothenburg to Vietnam and production of oral cholera vaccine in Vietnam1991•Licensure of monovalent killed whole-cell oral cholera vaccine developed at
cholera 9780 production of oral cholera vaccine in Vietnam1991•Licensure of monovalent killed whole-cell oral cholera vaccine developed at University of Gothenburg (Dukoral®); Dukoral mainly marketed as travelers’ vaccine1997•Reformulation
cholera 11284 fermenter•Pre-clinical studies of Euvichol2012•Phase I clinical study of Euvichol® in Korea2013•A global cholera vaccine stockpile is created•Gavi supports stockpile2014•WHO recommendation of OCV in humanitarian
cholera 12165 vaccine producers in Vietnam and India1.2The first step towards a safe, efficacious and affordable cholera vaccine for global use was taken through a product development partnership (PDP) between IVI and the
cholera 12498 Vietnam. Since the mid-1980s, Vietnam had been producing a low-cost killed monovalent O1 whole-cell oral cholera vaccine that did not contain the cholera toxin B subunit and hence did not require a buffer (making
cholera 12539 producing a low-cost killed monovalent O1 whole-cell oral cholera vaccine that did not contain the cholera toxin B subunit and hence did not require a buffer (making if more amenable to use in resource-limited
cholera 12753 settings) for the country’s public health programs [8], [9]. To protect from the emergence of Vibrio cholera e O139 seen in Bangladesh and India in the early 1990s this vaccine was reformulated into a bivalent
cholera 13940 that provided greater consistency in the product formulation and that better detected the removal of cholera toxin. With these changes a vaccine with a higher yield, lower production costs and hence a more affordable
cholera 15038 [13], [14], [15] and this was the first ever demonstration of strong sustained protection by an oral cholera vaccine. In 2009, the vaccine was licensed in both Vietnam (mORCVAX™) and India (Shanchol®), and
cholera 15349 OCV ($1.85 per dose) available for the global public market.The need for increased supply of low-cost cholera vaccines1.3Concerns about cholera increased steadily during the early 2000 as a result of the increased
cholera 15383 the global public market.The need for increased supply of low-cost cholera vaccines1.3Concerns about cholera increased steadily during the early 2000 as a result of the increased frequency of large and often protracted
cholera 15501 steadily during the early 2000 as a result of the increased frequency of large and often protracted cholera epidemics in sub-Saharan Africa and Asia and the emergence of new, more virulent, strains of V. cholerae
cholera 15605 cholera epidemics in sub-Saharan Africa and Asia and the emergence of new, more virulent, strains of V. cholera e O1. These public health concerns, as well as the availability of safe and effective OCVs [16], [17],
cholera 16082 risk for outbreaks in conjunction with other prevention and control strategies” [19]. Several major cholera outbreaks in 2010, including the devastating outbreak in Haiti with over 8000 deaths, further contributed
cholera 16228 devastating outbreak in Haiti with over 8000 deaths, further contributed to raising interest in the oral cholera vaccine by the international community and affected countries. The possibility of establishing an OCV
cholera 16618 likely [20]. During the same time, IVI began to develop an OCV demand forecast as a part of a global cholera investment case which was ultimately published in 2012 [21]. Through these estimates, it became apparent
cholera 18211 partnership with IVI, which started in September 2010.The technology transfer of IVI’s process for the oral cholera vaccine and associated quality control, including lot release assays, began in October 2010. Production,
cholera 19316 killed whole-cell OCV was safe, well-tolerated, and immunogenic [22].In June the same year, a global cholera vaccine stockpile was established by WHO to ensure prompt availability of oral cholera vaccines and
cholera 19403 year, a global cholera vaccine stockpile was established by WHO to ensure prompt availability of oral cholera vaccines and in December 2013, Gavi, the Vaccine Alliance announced a commitment of $115 million to
cholera 25175 make the expensive and risky R&D investments needed to develop new vaccines.In the case of the oral cholera vaccine, project funding was pooled from various sources of philanthropic and government support (e.g.,
cholera 27866 and in 2016, EuBiologics signed a Long-Term Arrangement until 2018 with UNICEF to supply their oral cholera vaccine globally. IVI also provided resources and support to EuBiologics in developing an international
cholera 28364 universities and research institutes played a crucial role in generating evidence around the burden of cholera and the feasibility of OCV use, thus creating demand. Following the WHO prequalification of Shanchol™,
cholera 29705 managing stockpile requests for preventive campaigns and shaping international consensus on comprehensive cholera control. GTFCC partner organizations have continued to contribute to the body of evidence on cholera
cholera 29806 cholera control. GTFCC partner organizations have continued to contribute to the body of evidence on cholera burden and control including use of OCV in alternative dosing regimens that provide flexibility and
cholera 31238 collective effort of many organizations, however it is important to recognize that the visibility of cholera as a disease of high mortality was magnified by large and tragic outbreaks such as occurred in Haiti.
diarrhea 577 Republic of KoreaPublication date (pmc-release): 10/2018Publication date (ppub): 10/2018AbstractCholera, a diarrhea l disease primarily affecting vulnerable populations in developing countries, is estimated to cause disease
diarrhea 3189 an example of a vaccine that was facing these challenges. Cholera is an acute, rapidly-dehydrating diarrhea l disease transmitted through water or food contaminated with the bacteria Vibrio cholerae O1 and O139.
infectious disease 1796 public health interventions, contributing significantly to the reduction of mortality and morbidity from infectious disease s in industrialized countries in the 20th century. Still the World Health Organization (WHO) estimates
infectious disease 1980 Health Organization (WHO) estimates 1.5 million children under the age of five die annually from infectious disease s that could have been prevented by vaccination [1].Several obstacles keep vaccines from reaching people

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