Consensus Meeting on International Standards for Oral Whole Cell Killed Cholera Vaccines, 17-18 May 2018, Seoul, Republic of Korea
A two-day meeting to discuss the development of International
Standards (ISs) for Oral Whole Cell Killed Cholera Vaccines
(OCVs) took place in Seoul, Republic of Korea, from 17-18 May
2018.
The conference was organized by the International Vaccine
Institute (IVI) with assistance from National Institute of Biological
Standards and Control (NIBSC) and funded by the Bill and
Melinda Gates Foundation (BMGF).
A total of 45 delegates representing vaccine manufacturers: EuBiologics Co., Ltd., Republic of
Korea; Hilleman Laboratories, India; Incepta Vaccine Ltd., Bangladesh; Shantha Biotechnics Pvt. Ltd., India; Vabiotech, Vietnam; and Valneva, Sweden; Research Institutions: IVI, Republic of Korea; icddr, b, Bangladesh; Health Canada, Canada; University of Gothenburg, Sweden; NIBSC, Great Britain; National Regulatory
Agencies (NRAs): Korean Ministry of Food and Drug Safety, Re-public of Korea; ANSM: French National Agency for Medicines and Health Products Safety, France; Bangladesh Association of
Pharmaceutical Industries, Bangladesh; WHO-RSS, Switzerland;
and independent experts met to discuss and share experiences on
in vitro and in vivo potency assays for batch release of OCVs, more
specifically the lipopolysaccharide (LPS) inhibition ELISA.
The two expected outcomes of the meeting were: 1) Agree on a
consensus for a set of candidate ISs for the LPS inhibition ELISA
and 2) Determine the need for and feasibility of an in vivo potency
assay. Here we summarize the discussions and main conclusions of
the meeting.
Vaccin Res Open J. 2019; 4(1): 12-18. doi: 10.17140/VROJ-4-112
