Japanese encephalitis vaccine achieves WHO prequalification, a key step in expanding access and protecting more children

October 9, 2013 by PATH

Milestone marks the first prequalified JE vaccine for children and the first Chinese vaccine manufacturer to achieve prequalification

Monica Graham, PATH, 206.302.6072, mgraham@path.org
Meng Li, China National Biotec Group Co., Ltd., +86-10-8466 3783, limeng3@sinopharm.com
Lingjiang Yang, Chengdu Institute of Biological Products Co., Ltd., +86-28-8441 8958, yanglingjiang@hotmail.com.

Seattle, United States, and Beijing, China, October 9, 2013–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.

More than 4 billion people live in JE-endemic regions in Southeast Asia and the Western Pacific. JE is carried by mosquitoes and causes a viral brain infection. It is the leading cause of viral neurological disease and disability in Asia, with nearly 70,000 cases and an estimated 10,000 to 15,000 deaths reported each year. However, because of limited surveillance and complexities in diagnosis, these figures likely underestimate JE's impact. Children who survive JE are often left with severe neurological damage. 

"We have reached two major milestones today. 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," said Dr. YANG Xiaoming, CEO of CNBG. "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."

Over the past decade, PATH has led a cross-sector collaboration with CNBG, CDIBP, and other global partners to pave the way for the prequalified JE vaccine–improving surveillance systems to better understand the disease burden; identifying the existing SA 14-14-2 live, attenuated JE vaccine and working to scale it up; collaborating on clinical trials; and helping countries plan for vaccine introduction. PATH worked with CDIBP to construct a new manufacturing facility that would meet rigorous international standards for vaccine quality and good manufacturing practices while ensuring adequate supply.

PATH also negotiated with CDIBP to establish an affordable public-sector price and supported vaccination campaigns in 11 countries outside of China that have already licensed or registered the vaccine for use ahead of WHO prequalification. Those campaigns have reached more than 200 million people to date.

"Today's prequalification means that all communities in JE regions will have access to a safe, affordable vaccine," said Dr. Kathleen Neuzil, director of PATH's Vaccine Access and Delivery Program. "We'll now work with our global health and in-country partners to accelerate the delivery of this vaccine to children in low-resource settings who are most vulnerable to the disease and its severe consequences."

PATH also leads a multicountry JE project that is taking a regional approach to the adoption, introduction, and scale-up of JE vaccination in endemic countries, building on the lessons learned and best practices developed over the past decade.

Read more about PATH's JE Project.

About China National Biotec Group Co., Ltd./Chengdu Institute of Biological Products Co., Ltd.

China National Biotec Group Co., Ltd. (CNBG) is a subsidiary of China National Pharmaceutical Group Corporation (Sinopharm Group Co., Ltd.) and research-driven company with its corporate headquarters in Beijing. One of the largest vaccine manufacturers in the world, it supplies more than 60 percent of vaccines for the Expanded Program on Immunization in China. CNBG consists of six institutes of biological products in China, including Chengdu Institute of Biological Products Co., Ltd. (CDIBP), which is the well-known manufacturer of live, attenuated Japanese encephalitis (JE) vaccine (SA14-14-2). In the past two decades, CDIBP has contributed to JE prevention and control by supplying more than 400 million doses of JE vaccine to China and other JE-endemic countries.