Updated on 11 October 2013
PATH and China National Biotec Group develop Japanese encephalitis (JE) vaccine in China with funding from the Bill & Melinda Gates Foundation
Singapore: PATH, a global health nonprofit organization, and China National Biotec Group, a leading vaccine manufacturer in China, has achieved prequalification by World Health Organization (WHO) for a vaccine to protect children against Japanese encephalitis (JE).
The SA 14-14-2 live, attenuated JE vaccine is the first JE vaccine to be prequalified for use in children by WHO. This milestone also marks the first time a Chinese vaccine manufacturer has achieved WHO prequalification. The vaccine is manufactured by Chengdu Institute of Biological Products, a subsidiary of CNBG.
With funding from the Bill & Melinda Gates Foundation, PATH led a series of pivotal clinical trials to establish the immunogenicity and safety of the vaccine in at-risk children and provided technical and financial support to help CDIBP meet the international manufacturing standards required for WHO prequalification.
“This milestone brings the world within reach of an audacious goal: the elimination of a devastating disease through expanded access to an affordable and lifesaving vaccine,” said Mr Steve Davis, PATH president and CEO. “Our groundbreaking collaboration with leading Chinese partners also helped lay the foundation for reshaping global vaccine supply, pricing, and accessibility through increased competition. This milestone signals China’s rising importance as a global supplier of high-quality vaccines for the most vulnerable children in the world.”
WHO prequalification is a critical step in expanding access to this lifesaving vaccine. The WHO decision allows United Nations’ procurement agencies to purchase the vaccine and serves as an endorsement of quality for countries interested in adopting it. Prequalification also opens the door for the vaccine’s inclusion in the GAVI Alliance portfolio and for essential vaccine financing for low-resource countries.