IVI: Affordable Oral Cholera Vaccine Goes Beyond Outbreak Response; Enables Mass-Scale Prevention by Solving Manufacturing Equation

Products: Euvichol®; Euvichol-Plus®

Product Type: Vaccines

Disease: Cholera

Cholera is a poverty-associated diarrheal disease that primarily affects vulnerable populations in low-income countries, causing disease in more than 2.5 million people every year and killing nearly 100,000.[i] Although an oral cholera vaccine (OCV) has been globally available since 2001, its high unit cost prevented wide use in endemic, resource-poor countries. With low demand, a lack of commercial incentive hampered production of cholera vaccines for the public sector market.

To fill this gap, the International Vaccine Institute (IVI) set out to facilitate the development and production of affordable, WHO-prequalified OCVs and bring them to market for global public use. Ultimately, the creation of a global stockpile of OCVs led to an adequate supply to address outbreaks and enabled widespread preventative campaigns to stop outbreaks before they start.

In 2009, following IVI’s first success with the development of the reformulated low-cost Shanchol™ vaccine, IVI committed to further increasing a global supply by partnering with another manufacturer, EuBiologics, a South Korean bioventure company who at the time had no experience in vaccine production. IVI provided hands-on training in fermentation, downstream processing, and quality control to manufacture another OCV. By the following year, a laboratory-scale technology transfer was complete, and by 2014, advanced clinical studies confirmed that Euvichol® was safe and induced an immune response.

“The creation of a global public stockpile of OCV continues to save countless lives and helped map a pathway to a world free of this devastating disease, an undertaking made possible by close partnerships between the public and private sectors.”

—DR. JEROME KIM, DIRECTOR GENERAL, IVI

It took fewer than seven years and approximately US$19.7 million from the start of IVI’s partnership with EuBiologics to achieve WHO prequalification of Euvichol® and Euvichol-Plus®—the same vaccine in innovative packaging enabling it to be sold for a slightly lower unit cost.

Achieving WHO-prequalification requires vaccines to undergo a standardized procedure to ensure they are safe and effective for use in vaccination campaigns. Prequalification also provides all the necessary information to vaccine procurement and delivery agencies like Gavi, the Vaccine Alliance, and UNICEF to help develop effective vaccination programs.

Overall, IVI’s Cholera Vaccine Program, a philanthropic-funded, public-private partnership, reversed the vicious cycle of high-cost/low-demand that often constricts vaccine research and production for neglected diseases. IVI’s partnership with EuBiologics increased supply and demand, reduced the price, and ultimately made protection against cholera more accessible to the people who need it most.

As of November 2019, over 42 million doses of Euvichol® and Euvichol-Plus® have been released globally, and IVI continues to work with EuBiologics to lower costs and increase production capacity by exploring further vaccine improvements.

i Cholera: Key Facts. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/cholera. Accessed October 2020.