Vaccine gets WHO nod for global use

Children in South Asia set to benefit from affordable Chinese product

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 Organization.

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.

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

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

"It's a good and reliable vaccine that can meet health demands in many countries, and the prequalification 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 economic significance, given that GAVI purchases highlight affordability and assistance for the poor.

China's JE vaccine, if exported under GAVI purchasing, would largely boost the United Nations' vaccine supply and improve vaccine access of the poor, Yip said, adding: "That's how 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 insight and resolve of the manufacturer to invest more than 800 million yuan ($131 million) to construct 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 paid off with the prequalification. "That's indeed worth the money."

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

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

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

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

Shen Qi, deputy director of the Institute for Biological Product Control of National Institutes for Food and Drug Control, said that without WHO prequalification, vaccines exported 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 million doses, she said.