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China close to entering WHO-approved global vaccine market

A technician works at a product line of the Inactivated H1N1 Influenza Vaccine in Sinovac Biotech Ltd., a Chinese vaccine making company, in
A technician works at a product line of the Inactivated H1N1 Influenza Vaccine in Sinovac Biotech Ltd., a Chinese vaccine making company, in

By Stephanie Nebehay

GENEVA (Reuters) - A Chinese-made vaccine is on the verge of being approved for aid agency use by the World Health Organization, a move that would be a first for China and open the door to lucrative regional and global markets, a leading health alliance said on Thursday.

The vaccine is against Japanese encephalitis, a debilitating mosquito-borne disease prevalent in Southeast Asia and the Far East that can be fatal, especially in children.

Made by Chengdu Institute, part of China's top vaccine maker China National Biotech Group (CNBG), the vaccine is likely to win so-called prequalification status from the World Health Organization (WHO), Seth Berkley, chief executive of the Global Alliance for Vaccines and Immunization (GAVI), said.

Prequalification means a product is eligible for quick procurement by aid agencies, including the U.N. Children's Fund (UNICEF), which buys vaccines for GAVI and its current market of 70 million children born each year in 73 poor countries.

"We think that the first vaccine that will receive prequalification will be Japanese encephalitis, out of a Chengdu manufacturer," Berkley told a news briefing.

"If that vaccine does receive prequalification, we will work with that company to try to get that vaccine out to more countries in Asia," he said. GAVI's board had already discussed the issue.

The WHO, a United Nations agency, gave its seal of approval to China's own national regulatory agency in March 2011, paving the way for domestic manufacturers to apply for prequalification for drugs and vaccines.

Japanese encephalitis, the most common cause of viral encephalitis in the Asia Pacific region, is now found from the far southeast of Russia to northern Australia and Papua New Guinea, and from Japan to western India, the WHO says.

Some 50,000 cases occur annually, of which 25 to 35 percent are fatal and one in three survivors has severe long-term disabilities.

A WHO spokeswoman said that prequalification for a vaccine against Japanese encephalitis, deemed a medium-term priority by the WHO, was "in the pipeline" but that discussions were confidential.

DOUBLE BENEFITS

Berkley, who held talks last month in China with government officials and domestic manufacturers, said GAVI was working with the WHO to try to help companies secure prequalification for different vaccines.

"If China is able to do that, it has two benefits. One, it has benefits potentially as another supplier for the world of vaccines of regional or global interest.

"But also it may, through economies of scale or technology transfers, allow China to launch some of these life-saving vaccines in its own country," he said.

GAVI is a public-private partnership that aims to bring life-saving vaccines to children in the poorest countries where people earn less than $1,520 a year on average.

China is no longer eligible for GAVI funding to receive vaccines, but Berkley noted GAVI had helped China vaccinate against hepatitis B, preventing many deaths from liver cancer.

Since being launched in 2000, the Geneva-based alliance has financed the immunization of more than 325 million children and prevented more than 5 million premature deaths, it says.

"It was only with the creation of GAVI that we could pull together a large enough market and a reliable payment scheme, that companies had to pay attention," Berkley said.

Manufacturers from India, South Korea, Africa, Eastern Europe and Latin America have joined in, he said. "So the market place is changing now to supply this much broader landscape."

GAVI has rolled out vaccines against the two largest killers of children in the developing world -- pneumonia (a pneumococcal vaccine) and deadly childhood diarrhoea (a rotavirus vaccine), the latter supplied by GlaxoSmithKline and Merck.

On Thursday, it announced the launch of a campaign to immunize 50 million people in seven African countries against meningitis A by the end of the year.

"I want to emphasize still the unfinished nature of the job. Today still every 20 seconds a child is dying from a vaccine-preventable disease because they don't have access to them," Berkley said.

(Reporting by Stephanie Nebehay; Editing by Andrew Osborn)

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