Homegrown vaccine gets approval from WHO

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Homegrown vaccine gets approval from WHO

By Shan Juan (China Daily) 09:39, October 10, 2013

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China has produced its first vaccine to gain prequalified approval from the World Health Organization.

The vaccine works against Japanese encephalitis and is manufactured by Chengdu Institute of Biological Products Co Ltd, which is affiliated with China National Biotec Group Co Ltd.

The WHO's stamp of approval for the vaccine's safety and efficacy means United Nations procuring agencies can now source it, according to WHO officials.

It only needs to be given in one dose, can be used for infants and is less expensive than other Japanese encephalitis vaccines.

WHO Director-General Margaret Chan said the vaccine "is a welcome development both in the fight to protect children in developing countries from Japanese encephalitis and in the future availability of vaccines more generally, as China is now producing vaccines up to WHO standards.

"There is a huge potential for the manufacture of vaccines in China and we hope to see more and more Chinese vaccines become prequalified by the WHO. The whole world will benefit," she noted.

The WHO recently added the vaccine to its list of prequalified medicines. According to the China State Food and Drug Administration on Wednesday, China's development, production and quality control of vaccines have won broad international recognition.

More importantly, the administration said, the latest WHO prequalification will make it easier to save children in developing countries and help China's vaccine industry better tap into international markets.

According to the WHO, the newly accessible vaccine is now available thanks to several years of collaboration between the WHO and authorities in China on vaccine production standards and regulations.

In March 2011, the WHO announced that the State Food and Drug Administration and affiliated institutions met WHO requirements for a functional vaccine regulatory system. Since then, vaccine manufacturers in China have become eligible to apply for WHO prequalification as long as their vaccines met WHO quality and safety standards.

The WHO's vaccine prequalification procedure guarantees that individual vaccines meet international standards of quality, safety and efficacy and are appropriate for the target population. United Nations procurement agencies can only purchase vaccines that have passed the rigorous review process involved.

Industry insiders expected that other Chinese manufacturers would soon follow in the footsteps of Chengdu Institute of Biological Products and apply for prequalification of their vaccines.

Japanese encephalitis, a mosquito-borne infection, is a virus that causes severe inflammation of the brain and in extreme cases, leads to coma. It is a major public health problem worldwide and endemic in parts of China, southeast Russia, and South and Southeast Asia, according to the WHO.

There is no specific treatment for Japanese encephalitis and the disease is preventable by vaccines.