New oral cholera vaccine gains WHO prequalification

SWITZERLAND—The World Health Organization (WHO) has prequalified Euvichol-S, a novel oral cholera vaccine (OCV), for use in cholera treatment.

This substantial development was revealed on April 12 and has so far received overwhelming support from Gavi, the Vaccine Alliance, and UNICEF.

Euvichol-S, manufactured by EuBiologicals Co., Ltd. in the Republic of Korea, provides a simpler formulation with comparable efficacy to existing vaccines.

 Its simplified formulation allows for rapid production scale-up, which contributes to increased global vaccination supply.

Notably, this clearance broadens the WHO prequalification list, which already contains Euvichol and Euvichol Plus.

This approval is expected to increase the global availability of oral cholera vaccines in 2024. An estimated 50 million doses will be available for the stockpile, up from 38 million doses in 2023.

 This discovery responds to the growing need for cholera vaccinations, which has been accompanied by a global increase in cholera incidence since 2021.

Cholera outbreaks have stressed global healthcare systems, particularly in the Comoros, Democratic Republic of the Congo, Ethiopia, Mozambique, Somalia, Zambia, and Zimbabwe.

Despite a large increase in oral cholera vaccine supplies between 2013 and 2023, persistent demand continues to strain the global stockpile pointing out  the critical need for complete cholera prevention and management methods, including access to adequate water and sanitation.

Speaking during the ceremony, Dr. Rogerio Gaspar, Director of the WHO Department for Regulation and Prequalification, stressed that the novel vaccine’s ability will speed up manufacturing and meet the urgent requirements of affected people.

For his part, Dr. Derrick Sim, Managing Director of Vaccine Markets and Health Security at Gavi, praised Euvichol-S’s prequalification as a critical resource for vulnerable populations around the world.

He went on to emphasize on the importance of timely vaccination access in light of the recent spike in cholera outbreaks and applauded EuBiologics for its involvement in increasing vaccine availability.

UNICEF, the main agency for vaccine procurement and delivery, has quickly obtained access to Euvichol-S doses and is dedicated to speeding up their distribution to affected countries.

Leila Pakkala, Director of UNICEF’s Supply Division, emphasized the organization’s commitment to expediting the supply of the newly licensed vaccine to nations in need, citing the potential to increase cholera vaccine procurement and distribution by more than 25%.

While EuBiologics remains the sole supplier of OCV to the worldwide stockpile, plans are underway to diversify manufacturers in the next few years.

Gavi, for its part, controls the OCV market and funds global stockpile doses, transportation, and vaccination operations in low-income countries.

UNICEF’s leadership in procurement and delivery, combined with the management of emergency response by the International Coordination Group for Vaccine Provision (ICG), is keen on on conducting a coordinated effort to battle cholera epidemics globally.

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