Geographic Range of JE - Credit CDC
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The World Health Organization has, for the first time, has provided its stamp of approval on a Chinese-manufactured vaccine – in this case for the prevention of Japanese Encephalitis (JE). While not found in Europe or North America, JE is the number one cause of vaccine-preventable encephalitis in Asia and the western Pacific.
As the following press release explains, today’s announcement is expected to open the door to other Chinese manufactured vaccines being approved in the future.
Newly accessible Japanese encephalitis vaccine will make saving children easier in developing countries
First vaccine from China to be prequalified by WHO
News release
9 October 2013 | GENEVA - A newly accessible vaccine against Japanese encephalitis is going to make the protection of more children in developing countries easier. The vaccine, manufactured in China, only needs to be given in one dose, it can be used for infants, and it is less expensive than other Japanese encephalitis vaccines.
Today, WHO has added the vaccine to its list of prequalified medicines, meaning that WHO has given the vaccine its stamp of approval in safety and efficacy terms, and United Nations procuring agencies can now source this vaccine. This is the first Chinese-produced vaccine to be prequalified by WHO.
“This is a welcome development both in the fight to protect children in developing countries from JE and in the future availability of vaccines more generally, as China is now producing vaccines up to WHO standards,” says WHO Director-General Dr Margaret Chan. “There is a huge potential for vaccine manufacture in China and we hope to see more and more Chinese vaccines become WHO prequalified. The whole world will benefit.”
Japanese encephalitis, a mosquito-borne flavivirus infection is a severe disease that involves inflammation of the brain. It is major public health problem and is endemic with seasonal distribution in parts of China, the Russian Federation’s south-east, and South and South-East Asia. As there is no specific treatment for Japanese encephalitis, supportive care in a medical facility is important to reduce the risk of death or disability. The disease is preventable by proven effective vaccines.
The newly accessible vaccine is available to the world now thanks to the outcome of several years of collaboration between WHO and the authorities of China on vaccine production standards and regulation.
In March 2011, WHO announced that the national drug regulatory authority of China, the State Food and Drug Administration (SFDA), and affiliated institutions, had met WHO indicators for a functional vaccine regulatory system. Herewith vaccine manufacturers in China became eligible to apply for WHO prequalification of vaccines, as long as their vaccines met WHO quality and safety standards.
The vaccine prequalification procedure is a service provided by WHO which guarantees that individual vaccines meet international standards of quality, safety and efficacy and are appropriate for the target population. United Nations procurement agencies can only purchase vaccines that have "passed" the rigorous review process involved.
It is expected that other Chinese manufacturers will soon follow suit and apply for prequalification of their vaccines. This is expected to have a significant, beneficial impact on global supply of vaccines of assured quality.
