NIBSC, IVI jointly organize meeting on cholera vaccine standardization
Organized in Seoul, South Korea on May 17-18 by colleagues at the International Vaccine Institute (IVI) and NIBSC, and supported by the Bill and Melinda Gates foundation, the Meeting on International Standards for Oral Cholera vaccines saw experts review potency tests used for the batch release.
One of the key topics was the need for standards to harmonize the LPS inhibition ELISA, an in vitro assay commonly used for batch release, across manufacturers and regulatory agencies.
Delegates at the meeting on International Standards for Oral Cholera Vaccines in Seoul, South Korea. Image Courtesy of the International Vaccine Institute (IVI)
During the meeting attendees agreed on the importance of developing reference reagents for coating antigens and primary detection antibodies used in this ELISA, as well as a reference vaccine. Delegates highlighted the need for these reagents to be tested by a wide range of laboratories in an international collaborative study.
The proposed reference reagents will be filled and freeze-dried at the NIBSC specialized manufacturing facility. Pending financial support, materials should be available within four to five years. The standards will support delivery of oral cholera vaccines for public health campaigns in low and middle income countries and the management of the global WHO stockpile.
Dr. Viliam Pavliak, Head of Vaccine Process Development at IVI and organizer of the meeting commented: “The meeting provided us with important information on the ELISA assay formats used by various manufacturers and regulators to support batch release of oral cholera vaccines. Participants agreed on development of the set of reference reagents for this assay to help accelerate the batch release of this life saving vaccine.”
A full report from the meeting is due to be submitted for publication in a peer reviewed journal.
About International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is the world’s only international organization devoted exclusively to developing and introducing new and improved vaccines to protect the world’s poorest people, especially children in developing countries. Established in 1997, IVI operates as an independent international organization under a treaty signed by 35 countries and the World Health Organization. The Institute conducts research in nearly 30 countries throughout Asia, Africa and Latin America on vaccines against enteric and diarrheal infections such as cholera and typhoid, Japanese encephalitis, MERS-CoV, tuberculosis, and dengue fever; and develops new and improved vaccines at its headquarters in Seoul, Republic of Korea. For more information, visit www.ivi.int
The National Institute for Biological Standards and Control (NIBSC) is a world leader in assuring the quality of biological medicines through product testing, developing standards and reference materials and carrying out applied research. NIBSC is a center of the Medicines and Healthcare products Regulatory Agency which also includes CPRD and MHRA. The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health.