Geneva/New York — Gavi, the Vaccine Alliance and UNICEF welcome the news that a new oral cholera vaccine (OCV), Euvichol-S, has now received WHO prequalification and can be made available to countries around the world. The prequalification of this new product will help EuBiologics, the manufacturer, produce more volumes of vaccine, faster, and at a lower cost - a key step to expanding supply amidst the ongoing acute global upsurge of cholera outbreaks.Today's approval will help increase the overall supply of OCV available in 2024, with approximately 50 million doses now forecasted to be available to the global stockpile this year, compared to 38 million in 2023. Euvichol-S is an important product innovation: a simplified formulation of Euvichol-Plus that reduces the number of vaccine components - delivering a vaccine that studies have shown remains equally effective against key cholera serogroups while lowering production cost and complexity - thus allowing for larger volumes to be produced faster.
Cholera has been surging globally since 2021, with high case fatality rates despite availability of simple, effective and affordable treatment. The large number of outbreaks has led to unprecedented demand for vaccines from impacted countries. While global OCV supply has increased eighteen-fold between 2013 and 2023, the large and sustained spike in demand has put a strain on the global stockpile of OCV. Partners and countries are working urgently on cholera response, prevention and control measures in the face of this crisis, and have called on countries, manufacturers and others to support. Most recently, Gavi, UNICEF and partners announced the largest ever global deployment of cholera diagnostics to support surveillance and response.
"Prequalification of Euvichol-S represents a lifeline for vulnerable communities around the world," said Dr Derrick Sim, Managing Director of Vaccine Markets & Health Security at Gavi. "Every vaccine dose delivered through Gavi programmes today represents years of planning and investment to shape the market so supply matches countries' needs. The approval of this new product could not have come at a more important time given the acute upsurge of cholera outbreaks we are seeing worldwide. We commend EuBiologics for their role in ensuring countries around the world have access to cholera vaccine as part of their response toolkit."
EuBiologics is currently the only supplier of OCV to the global stockpile, although other manufacturers are expected to have products available in the coming years. Gavi, the Vaccine Alliance works to shape the OCV market, and funds the global stockpile of OCV doses, along with transport and vaccination activities in lower-income countries. UNICEF leads on procurement and delivery of doses to countries. Use of the stockpile for emergency response is overseen by the International Coordinating Group for Vaccine Provision (ICG), led by WHO.
"Despite cholera being preventable and easily treatable, children continue to suffer from this potentially fatal disease. UNICEF has already secured access to all the available doses of the just-approved vaccine and will deliver these to the countries at the highest possible speed," said Leila Pakkala, Director of UNICEF Supply Division. "The approval means that UNICEF can increase the procurement and delivery of cholera vaccines by more than 25%, pushing back harder on deadly cholera outbreaks."
Notes to editors
- The development of Euvichol-S is a collaboration between EuBiologics, the International Vaccine Institute (IVI), and the Bill and Melinda Gates Foundation.
- Find out more about the science behind Euvichol-S via the Lancet.
- Statement by ICG on current cholera upsurge
About Gavi, the Vaccine Alliance
Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate more than half the world's children against some of the world's deadliest diseases. The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners. View the full list of donor governments and other leading organisations that fund Gavi's work here.
Since its inception in 2000, Gavi has helped to immunise a whole generation - over 1 billion children - and prevented more than 17.3 million future deaths, helping to halve child mortality in 78 lower-income countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningococcal and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation, above all the zero-dose children who have not received even a single vaccine shot. The Vaccine Alliance employs innovative finance and the latest technology - from drones to biometrics - to save lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Facebook and Twitter.
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About UNICEF
UNICEF works in some of the world's toughest places, to reach the world's most disadvantaged children. Across more than 190 countries and territories, we work for every child, everywhere, to build a better world for everyone.
For more information about UNICEF and its work, visit: www.unicef.org
