China to join global vaccine market
Seeking WHO’s seal of approval
GENEVA 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 Thursday.
The vaccine is to prevent 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, the vaccine is likely to win so-called pre-qualification status from the World Health Organization, said Seth Berkley, chief executive of the Global Alliance for Vaccines and Immunization.
Prequalification means a product is eligible for quick procurement by aid agencies, including the UN Children’s Fund (UNICEF), which buys vaccines for the alliance and its current market of 70 million children born each year in 73 poor countries.
“We think that the first vaccine that will receive pre-qualification will be Japanese encephalitis, out of a Chengdu manufacturer,” Berkley told a news briefing.
“If that vaccine does receive pre-qualification, we will work with that company to try to get that vaccine out to more countries in Asia,” he said. The alliance’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 pre-qualification 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 said.
Some 50,000 cases occur annually, of which 25 to 35 per cent are fatal and one in three survivors has severe long-term disabilities.
A WHO spokeswoman said that pre-qualification for a vaccine against Japanese encephalitis, deemed a medium-term priority by the WHO, was “in the pipeline” but that discussions were confidential.
Berkley, who held talks last month in China with government officials and domestic manufacturers, said the alliance was working with the WHO to try to help companies secure pre-qualification 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.
The Global Alliance for Vaccines and Immunization is a public-private partnership that aims to bring life-saving vaccines to children in the poorest countries where people, on average, earn less than $1,520 a year.
China is no longer eligible for alliance funding to receive vaccines, but Berkley noted the alliance had helped China vaccinate against hepatitis B, preventing many deaths from liver cancer. Since launching in 2000, the Geneva-based alliance has financed the immunization of more than 325 million children and prevented more than five million premature deaths, it said.
“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.
“I want to emphasize the unfinished nature of the job,” he said. “Every 20 seconds a child is dying from a vaccine-preventable disease because they don’t have access to them.”