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A Medical First for China: WHO Grants Prequalification to Chinese Vaccine

Posted on Nov 11, 2013 by Ailee Slater ()  | Tags: China, vaccines, Japanese encephalitis, Japanese encephalitis vaccine, WHO, the WHO Prequalification of Medicines Programme, the United Nations, UNICEF

Last month, for the first time in history, the World Health Organization (WHO) approved a vaccine created in China. With WHO approval, this vaccine to protect infants, children and adults from Japanese encephalitis may now be sold around the world, and medical workers are hopeful that the vaccine will mean cheap protection against this rare but fatal disease. Perhaps more important, however, is the fact that China has at last demonstrated its ability to become a large scale producer of vaccines – which could mean better medical care across the globe. 

Before the production of this Japanese encephalitis vaccine, China had not been able to create a product that would pass the WHO Prequalification of Medicines Programme (PQP). The WHO Prequalification Programme will only endorse medicines that have been proven both safe and effective. Although countries like the United States produce a good deal of such vaccines, China has not – until now. With the Japanese encephalitis vaccine receiving WHO approval, that product may now be distributed U.N. agencies, which is very good news for countries affected by the disease. 

The Japanese encephalitis virus is most prevalent in South Asia, Southeast Asia and the western Pacific region. Transmitted through mosquito bites, the JE virus will often cause mild symptoms or no symptoms at all. However, the virus will sometimes result in headache, a high fever or convulsions – and around one in four symptomatic cases will prove fatal. Even patients who do survive these extreme symptoms may experience lasting damage to the nervous system. 

At the moment there is no cure for the virus, but Japanese encephalitis is preventable through vaccination. Unfortunately, this vaccination is expensive and requires three visits to the doctor, which is not always possible in regions without access to adequate health services. 

The Chinese-produced JE vaccination, however, is much less expensive than any similar product on the market. Now that it has received the go ahead from the WHO Prequalification Programme, this JE vaccine should be able to offer inexpensive protection to a great number of children and adults living in countries where the virus is common, and where they were previously unable to afford that health care. With WHO approval, agencies such as UNICEF (The United Nation’s Children’s Fund) can distribute the vaccine for little or no cost to people in developing nations. 

Japanese encephalitis has become more and more common over the past two decades, due to an expansion of rice production and the reliance on irrigation systems. New irrigation means more flooded areas, which in turn leads to an increase in mosquito populations. With more mosquitos present, the risk increases that the insects will bite a bird or livestock animal infected with the JE virus, and then pass it along to humans. The JE virus can circulate amongst bird and reproduce in pigs, although neither animal will be affected by the virus.   

In China, a vaccine to protect against the Japanese encephalitis virus has been on the market since 1988. Although a few other countries in Asia have purchased the vaccine for many years, WHO prequalification will lead to an even bigger market for the medicine, and of course, will mean that charity agencies like UNICEF can distribute it as well. The prequalified vaccine is a result of collaboration between China and the World Health Organization, which worked with Chinese authorities to ensure that the vaccine was produced in a way that would meet WHO standards. Since 2011, China has been given the go-ahead by WHO to apply for prequalification, and the JE vaccine marks the first time that the country has done so.

With approval of the JE vaccine, it is likely that other medical manufacturers in China will soon begin to seek WHO prequalifications for their products. Deputy director with China's National Institutes for Food and Drug Control, Wang Junzhi has said that other Chinese vaccines will apply for prequalification in the coming year, including a vaccination for the flu, a hepatitis E vaccine, and a vaccination that can be taken orally to prevent polio. China already has a huge domestic vaccination market, and the nation’s interest in WHO prequalification had garnered much attention from health care workers around the world.


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