The aims to make quality priority medicines and vaccines available for those in need. The Organisation produces a list of prequalified medicines which is then used by agencies such as the United Nations, UNICEF and UNAIDS and others.
Prequalification also opens the door for the vaccine’s inclusion in the GAVI Alliance portfolio and for essential vaccine financing for low-resource countries.
PATH, a not-for-profit global health organisation, led a series of clinical trials to establish the safety and effectiveness of the vaccine in at-risk children. The project was funded by the Bill & Melinda Gates Foundation.
This is the first JE vaccine to be prequalified by the WHO for use in children. It is also the first time for a Chinese vaccine manufacturer (Chengdu Institute of Biological Products Co., Ltd.) to achieve qualification.
“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 ground-breaking 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.”
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. Children who survive JE are often left with severe neurological damage.