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Chinese vaccines pass WHO prequalification for first time


Updated: 2014-06-25

The WHO released news on October 9, 2013, the Japanese encephalitis attenuated live vaccine produced by Chengdu Biological Products Co of Sinopharm passed WHO prequalification for the first time. The approval recognizes the vaccine’s safety and efficacy by the WHO and can be prosured UN agencies procurement. It will make contributions to the global combat against Japanese encephalitis.

WHO Director-General Margaret Chan Fung Fu-chunsaid: “I’m pleased that Chinese vaccines are reach WHO standards. This will be conducive to protecting children in developing countries from Japanese encephalitis as well as help spread the vaccine in the future. China has great potential to produce vaccines, and we hope that more Chinese vaccines can pass the WHO prequalification to benefit the whole world.”

The vaccine prequalification program is conducted by the WHO, who assesses the production facilities, quality management system and products of vaccine manufacturers to ensure that their vaccines meet international standards of quality, safety and efficacy. The UN agencies can only purchase those qualified vaccines.

In March 2011, the State Food and Drug Administration and related agencies passed the WHO’s assessment and the vaccines became eligible to apply for the WHO prequalification. In January 2012, Chengdu Biological Products Co submitted formal summary documents about the Japanese encephalitis attenuated live vaccine to the WHO and started the application process. The Bill & Melinda Gates Foundation and the PATH provided technical support.

Seasonal and regional Japanese encephalitis occurs mainly in some parts of China, Southeast Russia, South Asia and Southeast Asia. The GAVI board meeting (Global Alliance for Vaccines and Immunization) took place in Cambodia in November 2013 to discuss the feasibility of providing Japanese encephalitis vaccines for related countries. If the board approves, countries can apply for Japanese encephalitis vaccines from 2014. In addition, the United Nations International Emergency Children's Fund is another major purchaser of the vaccine.


Link: China's Central Government / World Health Organization / United Nations Population Fund / UNICEF in China

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