Japanese encephalitis vaccine receives prequalification from WHO

PATH, a global health nonprofit organization, and China National Biotec Group Co., Ltd., a Chinese vaccine manufacturer, announced on Wednesday that a Japanese encephalitis vaccine received prequalification from the World Health Organization.

SA 14-14-2 live, attenuated JE vaccine is the first JE vaccine to receive prequalification for use in children by the WHO. The prequalification for the affordable vaccine could allow for the protection of millions of children against the disease. Prequalification allows U.N. procurement agencies to buy the vaccine, serves as an endorsement of quality for countries interested in adopting the vaccine and opens the door for the vaccine's inclusion in the GAVI Alliance portfolio.

"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," Steve Davis, the president and CEO of PATH, said. "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."

With funding from the Bill & Melinda Gates Foundation, PATH led multiple clinical trials to establish the safety and immunogenicity of the vaccine in at-risk children. Japanese encephalitis is the leading cause of viral neurological disease and disability in Asia.

"We have reached two major milestones today," Yang Xiaoming, the CEO of CNBG, said. "In addition to achieving WHO prequalification of our JE vaccine, we are proud to be the first Chinese manufacturer to produce a WHO-prequalified vaccine. As one of the largest vaccine manufacturers in the world, we take our mission of providing safe, effective, and affordable vaccines very seriously. With PATH's support and WHO's prequalification, we're proud to bring China onto the global stage as an important vaccine supplier serving GAVI-eligible countries."

Japanese encephalitis causes close to 70,000 cases annually with an estimated 10,000 to 15,000 deaths reported each year.