The pre-qualification of this new product - also known as Euvichol-S - 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.
The approval will help increase the overall supply of oral cholera vaccines (OCVs) available in 2024, with approximately 50 million doses now forecast 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 oral cholera vaccines supply has increased 18-fold between 2013 and 2023, the large and sustained spike in demand has put a strain on the global stockpile of OCVs.
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.
Global health security
“Pre-qualification of Euvichol-S represents a lifeline for vulnerable communities around the world,” said 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 its 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's 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.”
