The International Vaccine Institute has announced a $1.4 million grant from the Bill & Melinda Gates Foundation in support of its efforts to develop international standards for the manufacture and release of low-cost oral cholera vaccines.

According to IVI, there are currently no international standards or reference reagents available to vaccine manufacturers with respect to cholera vaccine antigens that contain bulk drug substances or products. The grant will assist IVI and the National Institute for Biological Standards and Control in the development and manufacture of WHO International Standards for 01 Inaba, 01 Ogawa, and 0139 V. cholerae LPS enzyme-linked immunosorbent assays (ELISAs), enabling existing and new oral cholera vaccine manufacturers and national control laboratories to calibrate in-house inhibition ELISAs as well as their life cycle management. The increased in-house capacity will assure proper regulation at the national level, help maintain the efficacy of the vaccine worldwide, and ensure a sufficient supply of low-cost prequalified vaccines in the thirty-nine Global Alliance for Vaccines and Immunization countries where demand currently exceeds the supply.

"Making available reference reagents will ensure uniform efficacy and allow multiple manufacturers to scale up production of low-cost cholera vaccine, which currently can't fulfill global demand," said Ravi Ganapathy, head of vaccine process development at IVI.