PATH

A Chinese-made vaccine has been given a stamp of approval by the World Health Organization (WHO) for the first time. The move could herald a step towards China becoming a global vaccine maker.

The vaccine protects children against Japanese encephalitis (JE), a viral brain infection spread by mosquitoes that is common in parts of east and south Asia. The vaccine, formally known as SA 14-14-2, was added to the WHO's prequalified medicines list last week, giving it a WHO quality and safety endorsement. The practical implication is that it can be used by United Nations agencies.

The global supply and availability of vaccines against JE will be “greatly enhanced by the prequalification”, says Bernhard Schwartländer, a WHO Representative in China. “Now, it is eligible, in principle, for purchase by UNICEF and the GAVI Alliance.” The GAVI Alliance, a public–private global health partnership based in Geneva, Switzerland, will be discussing the purchase of the JE vaccine at its board meeting in November.

"It's very meaningful that a Chinese vaccine can go global," says Wang Junzhi, deputy director of China's National Institutes for Food and Drug Control in Beijing.

Domestic sales of the JE vaccine, developed by the Chengdu Institute of Biological Products (CDIBP) and a subsidiary of the China National Biotec Group (CNBG) in Beijing, began in 1988. The vaccine has been widely exported since, but the WHO stamp of approval means that more countries will recognize its quality.

“We’ve exported 209 million doses to 11 Asian countries since 1999,” says Ge Yonghong, general manager of the CDIBP. “Our vaccine is good and affordable.”

“Our production capacity can meet the demands of endemic regions in China, and South and East Asia,” adds Yang Xiaoming, president of the CNBG.

Fundamental shift

Wang says that China is now lining up other vaccines for WHO prequalification, including a flu vaccine and an oral polio vaccine. And the WHO has put a Chinese-made hepatitis E vaccine, called Hecolin, on its vaccines prequalification priority list for 2013–14.

China ranks first in total global vaccine-production capacity, but its current focus is mainly on the domestic market. The WHO prequalification will allow that focus to change. “China's entrance into the global vaccine marketplace has the potential to fundamentally shift how vaccines are made, delivered and priced for the developing world,” says Steve Davis, president of PATH, a global health organization based in Seattle, Washington.

Schwartländer agrees. “The prequalification of a first vaccine ‘made in China’ is very significant indeed,” he says. “It shows that Chinese capacity in innovation and production of high quality vaccines can make a difference to the health of people not only in China, but also globally.”