Consensus Meeting on International Standards for Oral Whole Cell Killed Cholera Vaccines, 17-18 May 2018, Seoul, Republic of Korea

Abstract

Cholera causes an estimated 3 million cases of watery diarrhea and 100,000 deaths globally per year. Although the long-term solution for cholera control lies in universal access to safe drinking water and adequate sanitation, Oral Cholera Vaccines (OCVs) are the most cost-effective measure to contain and prevent the disease and are recommended by the World Health Organization (WHO) as part of an integrated strategy to control cholera. Currently, three OCVs are WHO prequalified and two of these are part of the cholera vaccine stockpile. Other OCVs have been developed for national use or are under development. Lipopolysaccharide (LPS) Inhibition enzyme-linked immunosorbent assays (ELISAs) are used by both manufacturers of OCVs and national regulatory agencies (NRAs) for: in process analysis, as a potency assay for drug substance and drug product batch release, and as an indicator of stability during the shelf life of OCVs. To ensure quality and consistency of this assay performed by different OCV manufacturers and NRAs, harmonization of assay reagents by the introduction of WHO International Standards (IS) for essential reagents is desirable. In May 2018, the International Vaccine Institute (IVI) with assistance from National Institute of Biological Standards and Control (NIBSC) and financial support from the Bill and Melinda Gates Foundation (BMGF) organized a meeting with representatives from vaccine manufacturers, NRAs, leading research institutions and independent experts to discuss and share experiences on potency assays for batch release and select reagents of the LPS Inhibition ELISA as candidate WHO ISs.