Newly accessible Japanese encephalitis vaccine will make saving children easier in developing countries

A newly accessible vaccine against Japanese encephalitis (JE) which will make the protection of more children in developing countries easier has been pre-qualified by the World Health Organization (WHO).

The vaccine, manufactured in China by the Chengdu Institute of Biological Products, a part of China National Biotec, only needs to be given in one dose, it can be used for infants, and it is less expensive than other JE vaccines. The pre-qualification means 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.

WHO Director General Margaret Chan said: “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. 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.”

Will open door for other Chinese vaccines
 
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.

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. This meant vaccine manufacturers in China became eligible to apply for WHO pre-qualification 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 pre-qualification of their vaccines. This is expected to have a significant, beneficial impact on global supply of vaccines of assured quality.