(File photo: VCG)
A Chinese vaccine against the Hepatitis E Virus (HEV) has been approved by the US Food and Drug Administration (FDA) to enter clinical trial in April.
The vaccine, sold under the trade name Hecolin, was initially developed by a research team from Xiamen University in east China's Fujian Province, and then transferred to and commercialized by the Xiamen Innovax Biotech Co. Ltd.
Hecolin has been used in China since 2012, and is the only licensed vaccine worldwide for the prevention of hepatitis E.
"This is the first time that FDA has given a green light to a Chinese vaccine for entering a clinical trial in the United States," said Zhang Jun, deputy director of National Institute of Diagnostics and Vaccine Development in Infectious Diseases at Xiamen University.
A Phase 1 clinical trial is scheduled for April, and will be conducted at Emory University in Atlanta, Georgia. The trial is sponsored by the National Institutes of Health (NIH), the primary agency of the US government responsible for biomedical and public health research.
The Phase 2 and 3 FDA-approved trials of the vaccine are expected to be done in a third country.
Hepatitis E is a liver disease caused by HEV, which is transmitted mainly through contaminated drinking water and food. Large outbreaks of the disease have been reported in at least 30 countries in Africa, Asia and North America.
According to a World Health Organization (WHO) position paper in 2015, there are approximately 20 million HEV infections, 3.4 million symptomatic cases, and 70,000 deaths globally every year.
The disease is typically most life-threatening among pregnant women, with a fatality of 10-50 percent. People with pre-existing chronic liver disease are prone to develop severe hepatitis following HEV infection.