Press Releases

International Vaccine Institute and Institut Pasteur Korea Sign MOU for Research and Development of Infectious Disease Therapeutics and Vaccines

April 1, 2021, GYEONGDO-DO and SEOUL, Korea – The International Vaccine Institute (IVI) and the Institut Pasteur Korea (IPK) signed a memorandum of understanding (MOU) for mutual collaboration in the research and development of therapeutics and vaccines for infectious diseases.   The MOU signing ceremony, […]

IVI signs Memorandum of Understanding with the Nepal Health Research Council

  March 12, 2021 – SEOUL, South Korea – The International Vaccine Institute (IVI) and the Nepal Health Research Council (NHRC) signed a Memorandum of Understanding (MoU) today during a virtual ceremony, laying the foundation for the two organizations to build research and development capacity […]

IVI welcomes Bangladesh’s accession to IVI

March 9, 2021 – SEOUL, South Korea – The International Vaccine Institute (IVI) welcomes the Cabinet of Bangladesh’s decision to ratify the IVI Establishment Agreement on February 22, 2021, completing the full accession process to IVI and becoming its 19th State Party.     Bangladesh is a founding signatory to IVI’s […]

George Bickerstaff re-elected Chairperson of the International Vaccine Institute’s Board of Trustees

February 22, 2021, SEOUL, Korea – The International Vaccine Institute (IVI) announced today that its Board of Trustees (BOT) re-elected Mr. George Bickerstaff as Chairperson of the BOT. His second three-year term will begin this May.   Mr. Bickerstaff has served on the IVI Board […]

GI-Cell, IVI sign MOU to develop next-generation COVID-19 vaccine

To cooperate in clinical development of COVID-19 vaccine candidate GI-Cell aims to prioritize supplying to Korea and developing countries by developing a vaccine that accommodates mass supply, viral mutation response, safety, convenience of patients January 26, 2021, SEOUL, Korea – GI-Cell, an affiliate of GI-Innovation, […]

Cellid, IVI exchange ‘COVID-19 Vaccine Research Service Contract’

IVI to analyze samples from Phase 1/2a trials of Cellid’s COVID-19 vaccine to evaluate immunogenicity   January 5, 2021, SEOUL, Korea –  Cellid and the International Vaccine Institute (IVI) have exchanged a collaborative research agreement to analyze the immunogenicity of the COVID-19 vaccine “AdCLD-CoV19”.   […]

IVI-SK’s new typhoid conjugate vaccine meets primary endpoints in phase III study in Nepal

Primary analysis also confirms safety of Vi-DT   December 17, 2020 – SEOUL, South Korea – Vi-DT typhoid conjugate vaccine, developed jointly by the International Vaccine Institute (IVI) and SK bioscience, has met the primary endpoints in a phase III study in Nepal. The primary […]

EuBiologics partners up with IVI in COVID-19 vaccine development

December 3, 2020, SEOUL, South Korea – The International Vaccine Institute (IVI) and EuBiologics exchanged an MOU to cooperate in clinical development of the COVID-19 vaccine the company is currently developing. The signing ceremony at IVI headquarters on December 2 was attended by Dr. Jerome […]

How to take action on AMR during the COVID-19 pandemic, a webinar co-hosted by IVI, ICARS, and the Embassy of Denmark in Korea

Free webinar, Evidence to Action: Advancing the Antimicrobial Resistance Agenda during a Pandemic, will be held on Thursday, December 3, 2020 at 9:00 Central European Time (17:00 Korean Standard Time). Registration available at ivi.int/evidence-to-action/    December 1, 2020, SEOUL, Korea — The International Vaccine Institute […]

IVI celebrates GivingTuesday with local community heroes and launches new donation initiative

December 1, 2020, SEOUL, South Korea – The International Vaccine Institute (IVI) visited the Seoul Gwanak Police Station today to recognize the Foreign Affairs section for their ongoing support for IVI’s activities and to deliver protective face masks and medical supplies for staff and volunteers. […]

IVI, ROK’s GDEF join forces to provide OCV vaccination to 540,000 people at risk of cholera in Nepal and Mozambique

GDEF’s US$8.05 million grant to support ECHO projects to prevent and control cholera and contribute to ‘Ending Cholera—A Global Roadmap to 2030’   The International Vaccine Institute (IVI) and the Republic of Korea’s Global Disease Eradication Fund (GDEF) have agreed to conduct joint projects to […]

IVI and the Ministry of Foreign Affairs and Human Mobility of Ecuador exchange MOU to pursue global health research & development

November 24, 2020, SEOUL, Republic of Korea — The International Vaccine Institute (IVI) and the Ministry of Foreign Affairs and Human Mobility of Ecuador exchanged a memorandum of understanding (MOU) today at IVI headquarters in Seoul, Republic of Korea to explore areas of collaboration in […]

LG Electronics, IVI join forces to conduct a ‘cholera vaccination and prevention project’ in Ethiopia

Project to provide vaccination for 40,000 residents in areas at risk of cholera and establish disease monitoring system with the Ethiopian Ministry of Health through the Armauer Hansen Research Institute (AHRI) To contribute to health authorities in policymaking for disease prevention by investigating waterborne diseases […]

IVI, Vaccine Innovative Technology ALliance Korea (VITAL-Korea) to partner up for innovative vaccine research and development

Aim to accelerate R&D and globalization of Korean vaccines to increase contributions to global health     The International Vaccine Institute (IVI) and the Vaccine Innovative Technology ALliance Korea (VITAL-Korea) agreed to join forces to promote vaccine research and development for global health.   IVI […]

International Vaccine Institute honored with Minister of Health and Welfare Award for achievements in biosafety

October 28, 2020, SEOUL, Korea —  The International Vaccine Institute (IVI) received an award by the Minister of Health and Welfare of the Republic of Korea for achievements in biosafety management.   IVI was honored with the Minister of Health and Welfare Award for achievements in […]

The International Vaccine Institute Supports a Global Campaign to Reduce the Spread of Covid-19

The International Vaccine Institute (IVI) is partnering with the World Sanity Foundation (WSF) in a campaign to encourage the use of face masks in an effort to reduce the spread of COVID-19 cases until a safe and effective vaccine becomes widely available.   The first […]

IVI and global health partners encourage vaccine diplomacy

October 13, 2020, SEOUL, Korea — The International Vaccine Institute (IVI) hosted a virtual State Forum today to advocate for multilateral cooperation through vaccine diplomacy. During a coronavirus pandemic with the continuous threat of more neglected infectious diseases spreading around the world, the forum convened […]

Typhoid: Study confirms Vi-DT conjugate vaccine is safe and immunogenic in children 6-23 months of age

September 17, 2020 – SEOUL, South Korea – A new study conducted by IVI in collaboration with SK bioscience shows that single-dose and two-dose regimens of Vi-DT typhoid conjugate vaccine (TCV) are safe and immunogenic in children 6-23 months of age, a group with high […]

IVI to ready clinical trial sites for COVID-19 vaccine efficacy trials in 4 countries

September 9, 2020 – SEOUL, South Korea – The International Vaccine Institute (IVI) announced today that the Bill & Melinda Gates Foundation awarded close to 1.5 million USD to IVI to support clinical trial site preparedness in four African and Asian countries to potentially support future COVID-19 Phase III efficacy vaccine trials.     Following successful completion of early-stage clinical trials of COVID-19 vaccine candidates, it will be […]

IVI welcomes Finland as 36th member state with flag-raising ceremony

  August 10, 2020 – SEOUL, South Korea – The flag of Finland was raised at the International Vaccine Institute (IVI) Headquarters today during a ceremony welcoming the country’s accession to IVI. Finland joined the Seoul-based international organization dedicated to vaccines for global health in […]

IVI welcomes the First Lady of South Korea to a solidarity event for global health and vaccine equity

IVI hosted the “Shared Future, Global Solidarity: Vaccines Save Lives” event at its headquarters on July 8, 2020, attended by the First Lady, Minister of Health, Vice Minister of Foreign Affairs, Director of National Institute of Health of Korea, and foreign ambassadors to South Korea […]

LINE and International Vaccine Institute Release BT21 Donation Stickers to Promote Global Vaccination and Vaccine Development

LINE FRIENDS’ BT21 characters featured in IVI sticker set to raise funds for child immunization initiatives and COVID-19 vaccine development   SEONGNAM, South Korea – June 30, 2020 – LINE Corporation today released a set of animated stickers together with the International Vaccine Institute (IVI) […]

IVI welcomes H.E. Einar H. Jensen, Ambassador of Denmark to South Korea, to discuss COVID-19 and AMR research

  June 16, 2020, SEOUL, South Korea – The International Vaccine Institute (IVI) welcomed His Excellency Einar H. Jensen, Ambassador of Denmark to South Korea, to IVI’s headquarters today to discuss developments in COVID-19 research as well as the institute’s ongoing studies on antimicrobial resistance […]

IVI partners with Seoul National University Hospital to start Phase 1/2 clinical trial of INOVIO’s COVID-19 DNA (INO-4800) vaccine in South Korea

First COVID-19 vaccine clinical study approved in South Korea funded by CEPI through INOVIO, and supported by KCDC/KNIH 2-stage trial to test INOVIO’s COVID-19 vaccine (INO-4800) using well-established DNA platform technology in adults     June 4, 2020, SEOUL, Korea and PLYMOUTH MEETING, PA, USA […]

CEPI awards up to US$14.1million to consortium of IVI and Bharat Biotech to advance development of Chikungunya vaccine in collaboration with Ind-CEPI

  June 3 2020, Oslo, Norway; Seoul, South Korea; Telangana, India—CEPI, the Coalition for Epidemic Preparedness Innovations, in collaboration with Ind-CEPI, has announced a new partnering agreement with a consortium comprising Bharat Biotech (BBIL) and the International Vaccine Institute (IVI) to advance the development of […]

IVI standardizes on Veeva Vault QualityDocs to Improve Operational Efficiency

SEOUL, KOREA — March 10, 2020 — Veeva Systems (NYSE:VEEV) today announced that the International Vaccine Institute (IVI), a not-for-profit International Organization established in 1997 as an initiative by the United Nations Development Programme (UNDP), has implemented Veeva Vault QualityDocs to improve control and real […]

IVI presents COVID-19 vaccine and epidemiology research to H.E. Philippe Lefort, Ambassador of France to Korea

May 22, 2020, SEOUL, South Korea – The International Vaccine Institute (IVI) invited French Ambassador to Korea, Philippe Lefort, to IVI’s headquarters in Seoul, Korea today to share ongoing research and development on COVID-19.   His Excellency Philippe Lefort, French Ambassador to Korea (left), and […]

IVI to strengthen COVID-19 surveillance in sub-Saharan Africa with support from Sweden

IVI will leverage its network of infectious disease surveillance sites to conduct epidemiological studies of COVID-19 in Madagascar and Burkina Faso Sida’s contribution will significantly build in-country capacity to proactively respond to the pandemic     May 21, 2020 – SEOUL, South Korea – The […]

INOVIO and GeneOne Life Science Report Positive Phase 1/2a Clinical Data With DNA Vaccine INO-4700 for MERS Coronavirus at the American Society of Gene & Cell Therapy (ASGCT) Conference

INO-4700 (GLS-5300) DNA vaccine demonstrates 100% binding and 92% neutralizing antibody responses against MERS-CoV INO-4800 DNA vaccine for COVID-19 currently in Phase 1 trial utilizes identical strategy targeting Spike protein and CELLECTRA intradermal delivery   PLYMOUTH MEETING, Pa. and SEOUL, KOREA – April 28, 2020 […]

LINE and International Vaccine Institute Team Up to Promote the Importance of Vaccination

LINE to offer an Official Account to IVI to promote the importance of vaccines and vaccination, as well as feature educational contents starring IVI Goodwill Ambassador Henry Lau LINE FRIENDS’ BT21 character IVI sticker set to be launched in the first half of the year […]

IVI, INOVIO, and KNIH to partner with CEPI in a Phase I/II clinical trial of INOVIO’s COVID-19 DNA vaccine in South Korea

  The Coalition for Epidemic Preparedness Innovations (CEPI) grants funding $6.9 million to INOVIO and IVI to conduct clinical testing in Korea for INOVIO’s COVID-19 vaccine candidate based on their well-established DNA platform technology Korea National Institute of Health (KNIH) to support IVI’s testing efforts […]

International Vaccine Institute and Technical University of Denmark to strengthen external quality assurance in the face of rising antimicrobial resistance in Asia

The Asia Pacific region is vulnerable to the emergence and spread of AMR but there is little high-quality data available on the extent of its impact Quality-assured data is essential for building tailored strategies for preventing the spread of drug-resistant infections IVI is part of […]

IVI and Sweden renew partnership to accelerate vaccines for global public health

    January 13, 2020 – SEOUL, South Korea – The International Vaccine Institute (IVI), a Seoul, Korea-based international organization, announced today that the Swedish International Development Cooperation Agency (Sida) will continue to support IVI’s mission to accelerate vaccine research and development for global health […]

IVI to lead critical standard reagents availability for oral cholera vaccine manufacturing to ensure their uniform efficacy and help meet global demand

  January 9, 2020 – SEOUL, South Korea – The International Vaccine Institute (IVI) received a $1.4 million grant from the Bill & Melinda Gates Foundation to ensure critical standards and reagents are available to low-cost oral cholera vaccine (OCV) manufacturers in the global health […]

IVI appoints three new members to its Board of Trustees

December 18, 2019 – SEOUL, South Korea – The International Vaccine Institute (IVI), a Seoul, Korea-based international organization dedicated to accelerating vaccines for global health, announced today that Professor Gordon Dougan, Dr. Melanie Saville, and Dr. Jean-Marie Okwo-Bele will join its Board of Trustees (BOT) […]

IVI to Accelerate Efforts in iNTS Vaccine Development

An award from the Wellcome Trust’s Affordable Innovations for Global Health Flagship will support IVI’s development and selection of potential vaccine candidates There is currently no vaccine available to protect against invasive non-typhoidal salmonella (iNTS)   November 13, 2019 – SEOUL, South Korea – The […]

IVI acquires GCLP certification from Korean Ministry of Food and Drug Safety

Institute expected to increase contributions to vaccine development activities worldwide   November 1, 2019 – SEOUL, South Korea – The International Vaccine Institute (IVI), an international organization for vaccine development and delivery headquartered in Seoul, has been granted Good Clinical Laboratory Practice (GCLP) certification by […]

IVI Awarded $4.5 Million Grant to Increase Accessibility of Oral Cholera Vaccine

October 28, 2019 – SEOUL, South Korea – The International Vaccine Institute (IVI) has received a $4.5 million grant from the Bill & Melinda Gates Foundation to simplify the current oral cholera vaccine (OCV) and further increase its accessibility. To date, the Gates Foundation has […]

IVI Discusses Expanding Support for Global Collaboration on Vaccine R&D and Delivery with Top Foreign Diplomats in Seoul

IVI State Forum 2019 was attended by 8th UN Secretary-General Ban Ki-moon, as well as 30 distinguished guests, including 17 ambassadors and top diplomats in Seoul, and senior Korean government officials.   The IVI State Forum 2019 was attended by ambassadors and senior diplomats from […]

IVI-led Consortium Awarded Fleming Fund Regional Grant to Improve Data Sharing in Fight against Antimicrobial Resistance

September 24, 2019, SEOUL, Korea – The Chief Medical Officer for England, Dame Sally Davies, announced today during the 74th UN General Assembly that a consortium led by the International Vaccine Institute (IVI) has been awarded a £2.7m Fleming Fund Regional Grant to improve data […]

IVI to help developing countries tackle the spread of infectious diseases by building capacity through vaccinology training in Seoul

19th IVI International Vaccinology Course brings together 175 trainees and faculty members from 49 countries The annual course has trained over 1,544 healthcare professionals in vaccine development, evaluation, production and policy to help increase developing nations’ capacity in vaccine research and immunization.     September […]

IVI acquires supplemental funding for Severe Typhoid in Africa Program (SETA Plus)

  August 28, 2019 – SEOUL, South Korea – The International Vaccine Institute (IVI) has received additional funds of $4.33 million from the Bill & Melinda Gates Foundation to expand Severe Typhoid in Africa (SETA) Program activities in close alignment with the “Effect of a […]

IVI Director General Dr. Jerome Kim to join the Human Vaccines Project’s Efforts as One of Four Distinguished Global Leaders to Decode the Human Immune System

August 16, 2019 – SEOUL, South Korea – Dr. Jerome Kim, Director General of the International Vaccine Institute (IVI), joins the Human Vaccines Project as one of four distinguished global leaders to help push forward its effort to solve one the greatest public health challenges […]

Prof. Young Chul Sung, biotech leader, personally donates US$8.4 million to IVI

Fund to support IVI’s projects to vaccinate children in developing countries throughout Asia-Pacific and Africa, to develop vaccines against emerging viruses   Prof. Park Sang-chul, President of the Korea Support Committee for IVI, Prof. Sung Young-chul with his donation pledge and IVI Director General Dr. […]

New push to develop world’s first vaccine against the deadly Strep A bacteria killing hundreds of thousand

Streptococcus pyogenes bacteria, which causes scarlet fever and other infections   30 May 2019, SEOUL, South Korea – The International Vaccine Institute (IVI) and Australia’s Murdoch Children’s Research Institute (MCRI) will coordinate a global push to free the world of Group A Streptococcus (Strep A), […]

IVI-led CAPTURA consortium wins Fleming Fund award for work on antimicrobial resistance (AMR) data across Asia

SEOUL, South Korea — An international consortium, led by the International Vaccine Institute (IVI), has received funding from the UK’s Fleming Fund Regional Grants to conduct the Capturing Data on Antimicrobial Resistance (AMR) Patterns and Trends in Use in Regions of Asia (CAPTURA) project. The […]

IVI receives $15.7 million grant to conduct phase III trials of new Vi-DT typhoid conjugate vaccine manufactured by SK bioscience of Korea

– Grant from the Bill & Melinda Gates Foundation will support additional supply of novel TCV at affordable cost for public sector markets   SEOUL, Korea –The International Vaccine Institute (IVI) announces receipt of a $15.7 million-dollar grant from the Bill & Melinda Gates Foundation […]

‘IVI Forum for Enhancement of Cooperation’ hosted jointly by the Korean Parliamentary Forum for Global Health, and KCDC under MOHW

– Event organized by IVI to discuss ways of cooperation to help increase Korea’s vaccine self-sufficiency, and accelerate globalization of the Korean vaccine industry Key participants pose for a commemorative photo at the ‘IVI Forum for Enhancement of Cooperation’ at the National Assembly of the […]

Vaccine study confirms sensitivity of cholera test

Recently, the sensitivity of fecal microbiological cultures for detecting cholera has come under question. Researchers reporting in PLOS Neglected Tropical Diseases investigated this claim using a ‘vaccine probe’ analysis of a completed cholera vaccine cluster randomized trial to support the sensitivity of conventional microbiological culture […]

Korean Pediatric Association, IVI, KSC exchange MOU

KPA, as group of experts in pediatric infectious diseases, to collaborate in academic research and projects on infectious disease prevention To support vaccination of children in developing countries through the ‘One for Three’ campaign, in partnership with IVI     The International Vaccine Institute (IVI), […]

IVI receives $3.2 million grant to support TCV effectiveness studies in West Africa

  SEOUL, Korea — The International Vaccine Institute (IVI) has been awarded a $3,238,974 grant from the Bill & Melinda Gates Foundation to provide technical assistance support for studies to measure the effectiveness of typhoid conjugate vaccine (TCV) in West Africa. This grant comes after […]

CEPI partners with IVI to accelerate development of vaccines against emerging global health threats

– Bilateral ‘Master Implementing Partner Services Agreement’ expected to enable IVI to provide technical capabilities to CEPI   Oslo, Norway; Seoul, Republic of Korea 11 February 2019—The Coalition for Epidemic Preparedness Innovations (CEPI) and the Republic of Korea-based International Vaccine Institute (IVI), an international organisation […]

Henry Lau joins IVI as Goodwill Ambassador

– Singer-songwriter, Henry to team up with the International Vaccine Institute (IVI), founded by the United Nations Development Programme to develop and deliver new vaccines for global health – IVI Director General Dr. Jerome Kim: “IVI is privileged to have Henry on board, and grateful […]

Nature Communications study addresses MDR typhoid

New study in Nature Communications reveals high burden of multi-drug resistant (MDR) typhoid fever in sub-Saharan Africa associated with two predominant genotypes – IVI epidemiologist Se Eun Park and collaborating scientists report data from Typhoid Fever Surveillance in Africa (TSAP) program and other sources   […]

THSTI, IVI held joint symposium on Nov. 22

First cooperative program between International Vaccine Institute and Translational Health Science and Technology Institute expected to help accelerate cooperation between India and IVI IVI and the Translational Health Science and Technology Institute (THSTI) of India held a joint symposium at IVI headquarters on November 22. […]

‘The Euvichol story’ published in Vaccine

“The Euvichol Story – Development and licensure of a safe, effective and affordable oral cholera vaccine through global public private partnerships” spearheaded by the International Vaccine Institute (IVI), has been published in Vaccine by Elsevier. The Euvichol Story published on October 9, 2018 in the […]

IVI accelerates development of MERS vaccine

– Institute jointly conducts phase 1/2a clinical trial of GeneOne Life Science’s GLS-5300 DNA MERS vaccine – IVI in search of additional promising candidate vaccines among developers worldwide, with support from Samsung Life Public Welfare Foundation   The International Vaccine Institute (IVI) said on September […]

IVI’s 18th Vaccinology Course gathers 120 international participants from 19 countries in Seoul September 3-7

Annual Course to update on the recent development in vaccinology, including basics of immunology, epidemiology, vaccine design and development Featured experts include: Stanley Plotkin (University of Pennsylvania), Dr. Barney Graham (US NIH), Dr. Randy Schoepp (USAMRID), Dr. Andy Pollard (University of Oxford), and Dr. Eric […]

KOICA, IVI team up with Mozambican MoH and INS, partners to vaccinate 190,000 people against cholera

– Joint initiative aims to prevent and control cholera, and secure sustainable cholera and diarrheal disease surveillance  – WASH campaign to promote access to clean water and behavioral change for appropriate sanitation and hygiene practice – “KOICA is joining the program to contribute to ‘Ending […]

IVI acquires $5 million grant to support process development, scale up of typhoid conjugate vaccine with SK Bioscience

– Grant from the Bill & Melinda Gates Foundation to allow SK Bioscience Co. Ltd, IVI to accelerate late-stage development of new vaccine necessary to achieve WHO prequalification The International Vaccine Institute (IVI), an international nonprofit organization devoted to providing vaccines critical to global public […]

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New affordable oral cholera vaccine receives prequalification by the World Health Organization

Author
ivi
Date
2016-10-10 03:18
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3199

New affordable oral cholera vaccine receives prequalification by the World Health Organization
- Oral cholera vaccine manufactured by Korean company EuBiologics following technology transfer from the International Vaccine Institute (IVI)
- Vaccine developed through international public-private partnership involving IVI and EuBiologics
- Euvichol will be used to protect the world’s underprivileged populations from cholera


 

SEOUL, KOREA – EuBiologics Co., Ltd. (EuBiologics) and the International Vaccine Institute (IVI) announced today that Euvichol®, an inactivated oral cholera vaccine (OCV), recently received prequalification from the World Health Organization (WHO). Developed to protect against epidemic and endemic cholera, the two-dose oral vaccine is low-cost and ready to use in a single-dose vial, facilitating its use in mass immunization programs in low-income countries.


 

“I am very pleased that Euvichol®, a vaccine whose development was enabled by IVI, was prequalified by WHO,” said Dr. Jerome Kim, IVI’s Director General. “This milestone shows that public-private partnerships - such as that between IVI and EuBiologics – are effective in developing vaccines against diseases of the poor like cholera.”


 

 

Euvichol® produced by EuBiologics

 

Prequalification by WHO of Euvichol® is the culmination of a five-year long partnership between IVI and EuBiologics to make a cholera vaccine for global health. It indicates that the vaccine meets WHO standards of quality and allows the vaccine to be procured by UN agencies and international organizations for use in countries around the world.


 

“Prequalification of Euvichol® by WHO represents a validation of EuBiologics’ quality management and the safety and efficacy of our vaccine,” said Dr. Yeong-Ok Baik, CEO of EuBiologics. “This approval also reinforces our commitment to work with partners to provide vaccines against infectious diseases affecting developing countries.”


 

Euvichol® is a reformulated inactivated OCV developed through IVI in collaboration with partners in Vietnam, Sweden, India, the United States of America, and the Republic of Korea. IVI earlier transferred the technology for OCV production to Shantha Biotechnics (part of the Sanofi group). The resultant cholera vaccine, Shanchol, was licensed in India in 2009 and WHO-prequalified in 2011. Shanchol provides sustained protection against cholera at an efficacy of 65% for at least five years, the longest duration of protection conferred by an OCV to date, demonstrated in a Phase III clinical trial in Kolkata, India.


 

The development of Euvichol® started after technology transfer from IVI with a preclinical study that included animal toxicology studies to establish safety prior to human studies. Consistency lots were produced at the EuBiologics cGMP (current Good Manufacturing Practice) facility in Chuncheon. A Phase I clinical study was successfully conducted in the Republic of Korea; followed by a Phase III trial in the Philippines, which established that Euvichol® was safe and highly immunogenic in humans. Euvichol® obtained export-only licensure from the Korean Ministry of Food and Drug Safety on January 28, 2015, and an application was submitted to WHO for prequalification afterwards.


 

Euvichol® is the second OCV transferred from IVI to obtain WHO prequalification, following the success of IVI’s partnership with Shantha Biotechnics for the prequalification of Shanchol in 2011. It is also the first OCV produced in the Republic of Korea for global health purposes. The development of Euvichol® was supported by the Bill & Melinda Gates Foundation, the Republic of Korea, and Sweden. The Global Health Investment Fund (an impact investment fund sponsored by the Bill & Melinda Gates Foundation and other partners), Korea-Seoul Life Science Fund (KSLSF), Korea Investment Global Frontier Fund (KIGFF), and Green Cross Corporation also provided funding to EuBiologics.


 

“WHO prequalification of Euvichol® is an essential step toward meeting global demand for low-cost oral cholera vaccines and this project is an excellent example of how collaboration among public, non-profit and commercial partners can be leveraged to save or improve lives around the world,” said Glenn Rockman, Partner at the Global Health Investment Fund.



 

Cholera is a potentially fatal infectious disease that causes acute watery diarrhea. It is a disease of poverty with explosive outbreaks striking in areas with poor sanitation and hygiene. According to WHO, between 1.4 million and 4.3 million people are infected and as many as 142,000 people die from cholera annually, the majority from low-income countries in Africa and South Asia. Major outbreaks have been recently reported in Iraq and Kenya.



 

Euvichol®, in conjunction with other preventive interventions and treatment, could play a key role in saving lives in countries where the disease is endemic and in natural disasters or humanitarian crises where outbreaks tend to occur. EuBiologics has initiated production of 6 million doses for 2016. Fill and finish will be conducted in the Hwasun Plant of the Green Cross Corporation, which is WHO prequalified. It will help meet demands for the vaccine from WHO, global health agencies, and governments to combat cholera. The company received a conditional award from UNICEF in October, 2015, with a long-term agreement to be executed shortly.



 

“Euvichol® will reinforce global health efforts to control cholera,” said Dr. Kim, “Now that Euvichol® is WHO-prequalified, IVI is looking forward to working with our partners to promote uptake of this vaccine and to make sure it is used in places where it is needed the most.”



 

“The prequalification of Euvichol® demonstrates the power of partnerships to successfully develop vaccines,” said Dr. Anita Zaidi, Head of Enteric and Diarrheal Diseases at the Bill & Melinda Gates Foundation. “We are pleased to be a part of this effort and congratulate IVI and Eubiologics for this major milestone. Euvichol®will go a long way in easing global cholera vaccine supply constraints at the global level, however a lot remains to be done to make sure the cholera vaccine will be used in populations and countries where cholera is a problem.”



 

About IVI
The International Vaccine Institute (IVI) is the world’s only international organization devoted exclusively to developing and introducing new and improved vaccines to protect the world’s poorest people, especially children in developing countries. Established in 1997, IVI operates as an independent international organization under a treaty signed by 35 countries and the World Health Organization. The Institute conducts research in more than 20 countries of Asia, Africa and Latin America on vaccines against enteric and diarrheal infections, Japanese encephalitis, MERS, and dengue fever, and develops new and improved vaccines at its headquarters in Seoul, Republic of Korea. For more information, please visit http://www.ivi.int.


 

About EuBiologics Co., Ltd
EuBiologics Co., Ltd. is a privately-held Korean biopharmaceutical company providing contract research and manufacturing services to domestic and international clients, in addition to building a portfolio of vaccines designed to improve global public health. The company was established in March 2010 with the objective of becoming a preferred strategic partner providing solutions for the development and manufacturing of biopharmaceutical products. EuB’s facilities are designed to manufacture a variety of mammalian cell and microbe-derived, protein-based therapeutics and antibodies. It provides customized services for various stages of product development, including cell line development, GMP production, validation and regulatory support. The company has also licensed the manufacturing technology necessary to produce an oral cholera vaccine from the International Vaccine Institute. In parallel with the development of its oral cholera vaccine product (“Euvichol”), EuBiologics is pursuing a number of other vaccines against diseases such as typhoid fever, HPV and PCV. The company’s administrative headquarters is in Seoul and its manufacturing facilities are located in a biotechnology cluster in Chuncheon, Korea. For additional information about the company, please visit http://www.eubiologics.com/ENG/.


 

Media Contact:


 

IVI
Tae Kyung Byun
Public Awareness/Advocacy Officer, IVI
Phone: +82-2-872-2801 (Ext. 159)
Mobile: +82-11-9773-6071
Email: tkbyun@ivi.int

 

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