Milestone marks the first prequalified JE vaccine for children and the first Chinese vaccine manufacturer to achieve prequalification
SEATTLE and BEIJING, Oct. 9, 2013 /PRNewswire-USNewswire/ -- An affordable vaccine to protect children against deadly Japanese encephalitis (JE) has been prequalified by the World Health Organization (WHO), paving the way to reach millions more children across Asia at risk for the disease. The announcement was made today by PATH, a global health nonprofit organization, and China National Biotec Group Co., Ltd. (CNBG), the leading vaccine manufacturer in China.
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 Co., Ltd. (CDIBP), 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 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.