Vaccine gets WHO nod for global use

By Shan Juan (China Daily) 08:11, November 01, 2013

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Children in South Asia set to benefit from affordable Chinese product

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

The vaccine, manufactured by the Chengdu Institute of Biological Products, has receivedWHO prequalification, which means it meets international standards for quality, safety andefficacy.

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

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

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

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

The GAVI Alliance brings together governments, the WHO, UNICEF, the World Bank,vaccine industries in industrialized and developing countries, research and technicalagencies and civil societies, as well as the Bill and Melinda Gates Foundation and otherprivate 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 devastatingimpact on children and their families, Berkley said.

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

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

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

Bernhard Schwartlander, WHO representative in China, said more than 4 billion peoplelive 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 vaccinesmanufactured in China.

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

PATH, an international nonprofit organization that aims to transform global health throughinnovation, supported the manufacturer with funding from the Bill and Melinda GatesFoundation for several years.

Ray Yip, chief representative of the foundation in China, said it has invested $39 millionsince 2004.

"It's a good and reliable vaccine that can meet health demands in many countries, and theprequalification helps the product to be seen and used in the near future," he said.

Yip pointed out, however, that the political significance was even greater than the economicsignificance, given that GAVI purchases highlight affordability and assistance for the poor.

China's JE vaccine, if exported under GAVI purchasing, would largely boost the UnitedNations' vaccine supply and improve vaccine access of the poor, Yip said, adding: "That'show China plays its role as a responsible and capable big country in the world."

Zhang Jiankang, chief representative for the PATH China Program, said it required insightand resolve of the manufacturer to invest more than 800 million yuan ($131 million) toconstruct facilities and train staff, with the aim of achieving the status.

Wu Yonglin, vice-president of the China National Biotec Group, said the efforts have paidoff with the prequalification. "That's indeed worth the money."

Lance Rodewald, team leader for the WHO China Office Expanded Program onImmunization, said WHO recognition of China's vaccine regulatory system laid foundationsfor the JE vaccine prequalification.

In March 2011, the WHO announced that China's top food and drug authority and affiliatedinstitutions met WHO indicators for a functional vaccine regulatory system.

Major indicators include licensing of vaccines, post-marketing surveillance and adversereaction monitoring, and monitoring of clinical vaccine trials.

The recognition allows China to export vaccines through UNICEF and GAVI to othercountries, he said.

Shen Qi, deputy director of the Institute for Biological Product Control of NationalInstitutes for Food and Drug Control, said that without WHO prequalification, vaccinesexported have to be registered at each destination country.

Chinese JE vaccines have been exported to neighboring countries like India and Vietnam,based on individual registration. The annual volume to India alone stood at 30 milliondoses, she said.

（Editor：ChenLidan、Gao Yinan）