AsianScientist (Oct. 10, 2013) – A new vaccine against Japanese encephalitis has been added by the World Health Organization (WHO) to its list of prequalified medicines.
The vaccine, manufactured in China, only needs to be given in one dose, can be used for infants, and is less expensive than other Japanese encephalitis vaccines. Pre-qualification status means that the 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 Southeast Asia. There is no specific treatment for Japanese encephalitis, but the disease is preventable by proven effective vaccines.
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.
It is expected that other Chinese manufacturers will soon follow suit and apply for prequalification of their vaccines.
Source: WHO; Photo: James Jordan/Flickr/CC.
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