Announcements

Euvichol-Plus®, ‘the world’s first plastic vial oral cholera vaccine,’ ready for global use

Author
ivi
Date
2018-01-09 08:28
Views
901

  • First shipment of new OCV from EuBiologics in South Korea to Zambia and Somalia from January 5 follows WHO approval in August 2017

  • Innovative packaging makes vaccine more affordable and easier to use

  • Up to 50 million doses in production to supply the global market

  • Developed by global public-private partnership to advance vaccines for global public health

  • New cholera vaccine available from WHO stockpile for use in health emergencies


SEOUL, January 8, 2018 -- 'Euvichol-Plus®', the world's first oral cholera vaccine (OCV) presented in plastic tube vials, is now available from World Health Organization (WHO) stockpile for use in health emergencies following the first shipment of 2.45 million doses to Zambia and Somalia from January 5. The vaccine, produced by EuBiologics, a South Korean pharmaceutical company, was prequalified by the WHO in August 2017, and can now be purchased by international procurement agencies and United Nations (UN) agencies.

Euvichol-Plus® is a low-cost oral cholera vaccine presented in innovative plastic packaging, and is an improved version of Euvichol®, an OCV presented in glass vials also produced by EuBiologics and WHO-approved in 2015. The new plastic packaging reduces the vial’s volume by nearly 30 percent and weight by over 50 percent, allowing easier transport and distribution of the vaccine and waste management. Compared with conventional glass vials, the plastic packaging is easier to open and administer.

Notably, Euvichol-Plus, priced at about $1.30 per dose, is 25 percent cheaper than Euvichol, which will enable aid and vaccine delivery organizations to procure more vaccines at the same cost. If Euvichol-Plus had existed just one year ago – and had been shipped in place of Euvichol – more than US $2.3 million would have been saved. These cost savings could have been used to purchase nearly 1.8 million more doses of Euvichol-Plus.



“We have recently seen an unprecedented rise in demand for cholera vaccine, which has been used to save lives and stop outbreaks in countries from Haiti to Somalia,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, which is funding the WHO’s global OCV stockpile. “This new, more cost-effective presentation will both allow us to continue to meet this demand and make it easier to transport and administer in the remote areas which desperately need it.”

“The new presentation of the oral cholera vaccine, Euvichol-Plus, should greatly simplify the delivery of vaccine to vulnerable populations. The vaccine will be easier to distribute and allow for simpler administration, especially during humanitarian emergencies where it is so critical to minimize logistical constraints,” said Prof. David Sack, chair of the Global Taskforce for Cholera Control (GTFCC).

Euvichol-Plus is produced at EuBiologics’ new manufacturing plant in Chuncheon, South Korea with financing from the Global Health Investment Fund and Korean venture capitals. With their new facility, EuBiologics is capable of producing up to 50 million doses per year, which should be sufficient to meet a rising global OCV demand. The company plans to gradually replace its supply of Euvichol with Euvichol-Plus, as development and aid organizations prefer the latter for immunization campaigns.

“We are proud to achieve WHO PQ of Euvichol-Plus, which allows us to significantly expand our OCV production and supply quality product at a lower cost, and start its shipment” said Dr. Yeong-Ok Baik, CEO of EuBiologics. “In collaboration with our partners, EuBiologics will redouble efforts to ensure stable supply of OCV in the global health market.”

Euvichol and Euvichol-Plus are the results of a successful global public-private partnership to accelerate the development and delivery of oral cholera vaccines for developing countries led by the South Korea-based International Vaccine Institute (IVI), a nonprofit international organization, and funded by a grant from the Bill & Melinda Gates Foundation, and the governments of Korea and Sweden.

“IVI is pleased to have successfully partnered with EuBiologics to support the clinical development, licensure and WHO prequalification of Euvichol and Euvichol-Plus,” said Dr. Julia Lynch, Deputy Director General for Development and Delivery at IVI. “Euvichol-Plus is an innovation success story, and IVI will continue to drive vaccine innovation in collaboration with our global partners.”

In 2016, Médecins Sans Frontières (MSF) vaccinated over 600,000 people in several countries with the oral cholera vaccine to prevent and control outbreaks. Timely vaccination is key to preventing a large number of cholera cases and deaths in emergency settings. Citing OCV supply shortages over the past few years, MSF welcomed the WHO prequalification of an improved, easier-to-use presentation. “This presentation with a reduced volume and a squeezable plastic tube will facilitate the implementation of vaccination activities,” MSF said.

As oral cholera vaccines do not appear to be temperature-sensitive like most vaccines, IVI will soon conduct a study to verify whether the vaccine remains safe and effective even when distributed out of the cold chain. A thermostable OCV is seen by public health experts as a “game changer” in cholera control, which can improve supply chain logistics and delivery practices, and reduce costs and the risk of preparation error and product wastage.

Cholera, a diarrheal infection caused by ingesting food or water contaminated with the bacterium Vibrio cholerae, is a disease that often strikes vulnerable populations in humanitarian crises. There are an estimated 2.9 million cholera cases and 95,000 deaths per year globally, with the disease remaining endemic in over 40 countries worldwide. The disease is treatable but can kill the patient within hours, if left untreated.

About International Vaccine Institute (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-CoV, 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 listed Korean biopharmaceutical company providing contract research and manufacturing services to domestic and international clients, in addition to building a portfolio of vaccines for global public health. Established in 2010, the company aims to become a preferred strategic partner providing solutions for development and manufacturing of biopharmaceutical products. The company has also licensed the manufacturing technology for an oral cholera vaccine from the International Vaccine Institute (IVI). In addition to the oral cholera vaccine products (“Euvichol” and “Euvichol-Plus”), EuBiologics is pursuing research and development for a number of other vaccines against diseases such as typhoid fever, MCVand PCV. Headquartered in Seoul, the company has its manufacturing facilities located in Chuncheon, Korea. For more information, visit http://www.eubiologics.com/en/main/

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Tae Kyung Byun
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