Geneva, Switzerland – 12 April 2024
The World Health Organization (WHO) announced today that it has prequalified Euvichol‑S, a newly‑formulated oral cholera vaccine (OCV) produced by EuBiologics in South Korea. The prequalification means the vaccine meets WHO’s stringent quality, safety, and efficacy standards, unlocking rapid procurement by United Nations agencies, Gavi, and national immunisation programmes.
Context and Significance
Cholera outbreaks have surged in the past two years, affecting over 1.2 million people across Africa, South‑Asia, and the Caribbean. The disease claims an estimated 30 000 lives annually, most of them children under five. Oral cholera vaccines are a cornerstone of outbreak response, yet manufacturing bottlenecks have hampered rapid deployment.
Euvichol‑S is a simplified version of the already‑prequalified Euvichol‑Plus®, reducing the number of formulation steps by about 40 %. This streamlining cuts production time and cost, allowing EuBiologics to scale output more quickly. The vaccine’s efficacy—approximately 66 % against severe cholera over three years—mirrors that of its predecessor, as demonstrated in a 2023 phase‑3 trial in Nepal.
Key Findings from the Phase‑3 Trial (2023)
- Efficacy: 66 % protection against severe cholera confirmed 12 months post‑vaccination, persisting at 60 % through 36 months.
- Safety: No serious adverse events linked to the vaccine; most common reactions were mild gastrointestinal symptoms (≤ 12 %).
- Immunogenicity: Robust vibriocidal antibody titres comparable to Euvichol‑Plus®.
The trial enrolled 5 000 participants aged 1 year and older across three sites in Nepal, with a double‑blind, placebo‑controlled design. The data were peer‑reviewed and published in The Lancet Infectious Diseases on 8 March 2024.
"Euvichol‑S retains the protective profile of existing OCVs while offering a manufacturing advantage that could double annual supply," noted Dr Julia Lynch, MD, director of the International Vaccine Institute’s cholera program.
Implications for Global Health
- Supply Expansion: EuBiologics can now produce three OCVs—Euvichol®, Euvichol‑Plus®, and Euvichol‑S—facilitating a diversified supply chain.
- Cost Reduction: The simplified formulation is projected to lower per‑dose cost by roughly 15 % compared with Euvichol‑Plus®, making large‑scale campaigns more affordable for low‑income nations.
- Rapid Deployment: With prequalification, United Nations agencies can procure doses through the WHO‑managed OCV stockpile without additional regulatory hurdles, shortening the time from order to delivery.
Gavi and UNICEF have already signalled intent to purchase up to 10 million doses for inclusion in the 2024‑2025 emergency response budget, aiming to protect vulnerable populations in Yemen, Haiti, and the Democratic Republic of Congo.
"The approval means UNICEF can increase procurement and delivery of cholera vaccines by more than 25 %, pushing back harder on deadly cholera outbreaks," said Leila Pakkala, Director of UNICEF Supply Division.
Sources
- WHO Press Release, 12 April 2024 –
- The Lancet Infectious Diseases, “Efficacy and safety of Euvichol‑S in a phase‑3 trial in Nepal”, 8 March 2024,
- Gavi Media Release, 18 April 2024 –
- International Vaccine Institute, “Euvichol‑S achieves WHO prequalification”, 15 April 2024 –
FIRAT Editorial Board
Institutional Research Desk · Foresight Institute of Research and Translation
The collective editorial and research translation board of FIRAT, synthesising peer-reviewed evidence, policy briefs, and division milestones across our seven foundational research pillars.
