On 30 May 2007, the first 120,000 doses of Purified Japanese Encephalitis Virus Vaccine passed the batch release of Chinese State Food and Drug Administration (SFDA) and entered the Chinese market (PRC).
By the end of July, all batches were vaccinated and no abnormal/adverse reactions occurred.
Purified Japanese Encephalitis Virus Vaccine is the third viral vaccine product of Tianyuan which got marketing approval.
Japanese Encephalitis Virus
Japanese encephalitis (JE) is a disease caused by a flavivirus that affects the membranes around the brain.
Japanese encephalitis (JE) is a mosquito-borne severe viral disease that is spread by infected mosquitoes in the rural regions of Asia. It is the leading cause of viral encephalitis, that affects the central nervous system and causes severe complications and death
Approximately 30,000-50,000 clinical cases of JE are reported annually from the People's Republic of China (PRC), Korea, Japan, Southeast Asia, the Indian subcontinent, and parts of Oceania.
Japanese encephalitis is a seasonal disease that usually occurs in the summer and fall in the temperate regions. In tropical and subtropical regions, disease patterns vary with rainy seasons and irrigation practices. Patterns of JE viral transmission vary regionally, within individual countries, and from year to year.
There is no specific treatment for Japanese encephalitis. Antibiotics are not effective against viruses, and no effective anti-viral drugs have been discovered.
Purified JEV vaccine is derived from the Japanese encephalitis virus strain JEV SA14-14-2 grown on primary cell culture of shrewmouse kidney cells. The strains for vaccine production are approved by the Chinese State Food and Drug Administration.
After inactivation with beta-propiolactone and centrifugation the virus is purified using a combination of centrifugation, ultrafiltration, chromatography, and filtration steps. The final formulation also contains human serum albumin for stabilization and Thiomersal as a preservative.
Tianyuan's purified JEV vaccine "AIPUSHENG" is a highly effective vaccine for the prevention of infections by Japanese encephalitis virus.