It’s official!

First Chinese-made vaccine given WHO approval

China has received approval from the World Health Organization (WHO) for a live attenuated vaccine against Japanese encephalitis (JE), a viral brain infection transferred by mosquitoes that causes 10-15,000 deaths per year, mostly in children under 15 years old. The vaccine, called SA 14-14-2, will now be readily available for global distribution.

The vaccine, manufactured by Chengdu Institute of Biological Products Co., had been used locally in China since 1988, but now that it has been added to the WHO’s list of prequalified medicines, it will be more accessible; organizations like UNICEF and the GAVI Alliance can now purchase it. China ranks first in the world in terms of vaccine production capacity, so this prequalification can have great effects on the availability of the vaccine.

“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,” said Steve Davis, president of the global health organization PATH.

The WHO’s prequalification sends a message about the vaccine’s quality to countries that are interested in it. This means that countries where JE is endemic could get greater access to the vaccine at a lower price.

The Chinese-developed vaccine against JE is expected to sell at 30 cents per dose. The price for an Indian-manufactured vaccine against JE was already considered low locally in the Indian market, at $2.60 per dose, but with the WHO prequalification of this Chinese vaccine, that price has fallen much lower.

In addition to the cost, there are other benefits of the vaccine. SA 14-14-2 is the first vaccine to be approved for pediatric use. It can be administered as a single dose, which is more efficient.

This is the first time a Chinese vaccine has been prequalified by the WHO. In the past, China has received WHO approval for 50 active pharmaceutical ingredients – the raw materials purchased by other biotech manufacturing companies to generate medical compounds. There is also a bright outlook for China’s future with respect to potential prequalification for other vaccines.

The Chinese-made vaccine against hepatitis E (called Hecolin) has been placed on the WHO prequalification priority list for 2013-14. Other vaccines, such as those for the flu, polio virus, and rotavirus, are also being considered for the WHO prequalification application.

The Chinese JE vaccine was developed in collaboration with PATH, which ran the clinical trials to establish the vaccine’s safety and effectiveness. The project was supported by US $39 million from the Bill and Melinda Gates Foundation.

“Today’s prequalification means that all communities in JE regions will have access to a safe, affordable vaccine,” said Dr. Kathleen Neuzil, director of PATH’s Vaccine Access and Delivery Program. “We’ll now work with our global health and in-country partners to accelerate the delivery of this vaccine to children in low-resource settings who are most vulnerable to the disease and its severe consequences.”