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[BEIJING] Developing countries could benefit from a larger pipeline of cheaper vaccines following the verification of China's vaccine regulatory system by the WHO.

The WHO announced this month (1 March) that China's State Food and Drug Administration (SFDA) complies with international standards for regulation, allowing the country to supply vaccines through UN agencies, potentially boosting stocks for the developing world.

"The potential inclusion of vaccines from Chinese manufacturers offered to countries through UN procuring agencies is expected to have a significant, beneficial impact on the global supply of affordable vaccines of assured quality," Zuo Shuyan, an officer at the WHO Expanded Programme on Immunization told SciDev.Net.

China has 36 sites manufacturing 49 vaccines for 27 diseases with an annual capacity of nearly one billion doses, according to the SFDA. It is the 36th country to have its vaccine regulatory system approved by the WHO.

Vaccine manufacturers in China are now eligible to apply for WHO prequalification of individual vaccines, said Zuo, which is a guarantee that a vaccine meets international standards of quality, safety and efficacy.

"But it is expected that it will be a further one to two years before vaccines manufactured in China will be prequalified," he said.

Ray Yip, China programme director at the Bill & Melinda Gates Foundation, told Reuters last month the foundation is looking for Chinese manufacturers "to go global", instead of producing vaccines just for the Chinese market. He said one aim would be to cut the cost of the pneumococcal vaccine from US$100 per dose to US$5 per dose.

"Our focus is more of using China as a development partner to assist other countries, whether it be to develop better vaccines … rolling out diagnostic tools … or a better yielding rice," Yip said.

Shao Mingli, head of the SFDA, said that the WHO approval showed that China had improved vaccine regulation and could guarantee quality. He added: "It is a chance for China to make a much more significant contribution to global world vaccine needs".

China could be well placed to make cheaper versions of vaccines for the developing world market, according to Daniel Chin, senior programme officer for the Gates Foundation in China, who gave a presentation on the opportunities and challenges for vaccine production in the country at a TB vaccine conference last year.

Chin highlighted the first case of Chinese manufacturers supplying developing world markets: a vaccine for Japanese encephalitis produced by Chengdu Institute of Biological Products and PATH, an international health agency. The price was brought down to 25 US cents from US$2 and is sold in India and six other developing countries.

But he warned that there are major bottlenecks in regulatory procedures for vaccine development and approval that are slowing down China's capacity to roll out new vaccines.

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