The World Health Organization (WHO) has prequalified a new inactivated and simplified oral vaccine for cholera, Euvichol-S, to “rapidly increase” production capacity to overcome global shortages.
The decision marks the new vaccine as the third product of the same family of vaccines to be prequalified by WHO for the acute diarrhoeal illness.
Reported to affect around 473,000 people in 2022, according to WHO, cholera is caused by the ingestion of food or water which is contaminated with the bacterium Vibrio cholerae (V. cholerae).
The infection is currently a global threat to public health, severely impacting 23 countries, including Comoros, Ethiopia, Somalia, Zambia and Zimbabwe.
Vaccines work to provide the fastest intervention to prevent, limit and control cholera outbreaks. However, due to a lack of safe water, hygiene and sanitation, supplies have been at their lowest points.
The simplified vaccine was created by South Korean-based EuBiologics, the same company that designed the older prequalified versions of the vaccine, Euvichol and Euvichol-Plus, in alignment with WHO’s global efforts to end cholera by 2030.
“The new prequalification is hoped to enable a rapid increase in production and supply, which many communities battling with cholera outbreaks urgently need,” said Dr Rogerio Gaspar, director, WHO department for regulation and prequalification.
The phase 3 clinical trial comparing the lower-cost formulation, Euvichol-S, to Shanchol, conducted by the International Vaccines Institute (IVI), involved 2,530 participants with non-inferior seroconversion rates of Euvichol-S against V. cholerae O1, Inaba and Ogawa serotypes.
Results from the trial demonstrated that Euvichol-S was non-inferior in comparison to Shanchol. With a robust safety profile, the simplified vaccine showed potential as a promising solution to bridge the gap amid global shortages and rising demand.
EuBiologics’ chief executive officer, Dr Yeongok Baik, said: “We have already completed preparation for Euvichol-S manufacturing at our GMP facility and will be able to supply more than 15 million doses of this vaccine in 2024.”
The result of the simplified formulation came after the IVI received support from the Bill & Melinda Gates Foundation in 2019 to reformulate Euvichol-Plus, potentially reducing costs by 20% and increasing production capacity by 38%.