China's homegrown vaccine gets WHO nod for global use

China's homegrown vaccine gets WHO nod for global use

CHINA - Children in South Asia at risk from deadly Japanese encephalitis will be protected by China's first vaccine approved for global use by the World Health Organisation.

The vaccine, manufactured by the Chengdu Institute of Biological Products, has received WHO prequalification, which means it meets international standards for quality, safety and efficacy.

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

"There is a huge potential for vaccine manufacture in China and we hope to see more Chinese vaccines get WHO prequalification. The whole world will benefit," she said.

The GAVI Alliance, a public-private global health partnership committed to saving children and increasing access to immunization in poor countries, said it is preparing to make funding available for the vaccine.

"It's exciting," CEO Seth Berkley said. "The Chinese vaccine industry has huge potential to benefit children in the poorest countries by offering secure, predictable supply at affordable prices."

The GAVI Alliance brings together governments, the WHO, UNICEF, the World Bank, vaccine industries in industrialized and developing countries, research and technical agencies and civil societies, as well as the Bill and Melinda Gates Foundation and other private philanthropists.

Eligible countries whose children are at risk of Japanese encephalitis can apply for support, and Cambodia and Laos are expected to be among the first to submit applications.

Japanese encephalitis is a vicious illness that strikes quickly and usually has a devastating impact on children and their families, Berkley said.

"With GAVI support for this new vaccine, the poorest countries in Asia will be able to protect their children from disability and death due to JE."

He said the board agreed in 2011 to provide GAVI-eligible countries with a vaccine prequalified by the WHO.

The final decision to open a funding window is to be taken at a board meeting in Cambodia in November.

Bernhard Schwartlander, WHO representative in China, said more than 4 billion people live in JE endemic areas, primarily in Southeast Asia and the Western Pacific.

"This is a great step forward, in a national and international context," he said.

WHO prequalification assures the equivalent regulatory standards are used for vaccines manufactured in China.

According to Schwartlander, the Chengdu manufacturer, which is affiliated with China National Biotec Group, has worked to improve the manufacturing processes of its JE vaccine to meet international standards.

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