China approves hepatitis E vaccine
Updated: 2012-01-11 20:31
BEIJING - China has approved a hepatitis E vaccine, claimed to be the world's first, said the Ministry of Science and Technology Wednesday.
The vaccine received the certificate for medicine production in December 2011, according to the State Food and Drug Administration.
A team of researchers from Xiamen University and Xiamen Innovax Biotech Co. Ltd. in southeast China's Fujian province had worked for 14 years to develop the vaccine, and the 863 program, the government-funded high-tech development initiative, began to sponsor the research in 2005, said the ministry statement.
The country will apply the vaccine to high-risk members of the population and work with international organizations to introduce it to other countries, the statement said.
The hepatitis E virus is shed in feces and spread via tainted water and food. According to the World Health Organization, one third of the global population is estimated to be infected by the virus and countries in South and East Asia report about 6.5 million infection cases every year.
In China, incidences of hepatitis E have increased notably and become the most common among all types of hepatitis infecting adults.
According to a research paper from the vaccine's development team published in The Lancet in August 2010, researchers conducted a trial involving 97,356 healthy participants in China. Half of them were given the vaccine and the other half a placebo.
The vaccine was given in three doses -- the second was given a month after the first and the third five months later.
Within a year of the third dose, 15 of the participants who were given placebos had contracted hepatitis E while no one in the vaccine group was infected, according to the report.