After more than a year of scrutiny and inspection by China’s State Food and Drug Administration (SFDA), a hepatitis E vaccine developed by Chinese scientists should be available by the end of the year.
Its approval by the SFDA follows phase III clinical trials published in the medical journal The Lancet in 2010, which found it to be 100 percent effective in preventing infection.
Xiamen Innovax Biotech (known as INNOVAX), the university’s research and development arm, is now preparing to take the vaccine through to market, according to Steven Gao, Innovax’s general manager.
It is anticipated that the Chinese vaccine will be the first in the world to go into production.
In 2007, GlaxoSmithKline (GSK) developed a separate vaccine, in collaboration with the United States Army. Phase II trials of the vaccine carried out in Nepal found it was more than 95 percent effective in preventing infection.
However, GSK did not take the vaccine forward for production, and efforts to fund further trials and commercialization through partnerships have been unsuccessful, according to Eleanor Bunch, a spokeswoman for the company. But she said GSK remains “willing to co-operate with third parties to share results and expertise gained.”
The hepatitis E virus causes around 20 million infections a year. These result in around three million acute illnesses and 70,000 deaths annually. It is particularly dangerous for pregnant women, who can develop an acute form of the disease that is lethal in 20 percent of cases.
The prospect of a vaccine was welcomed by Buddha Basnyat, from the Oxford University Clinical Research Unit-Nepal, hosted by Patan Hospital in Kathmandu. “I think it is great that this important vaccine is finally available for use,” he told SciDev.Net.
Tarik Jasarevic, a World Health Organization communications officer, told SciDev.Net that “China should be commended for developing the first HEV [hepatitis E virus] licensed vaccine.”
Xiamen University and INNOVAX now plan to apply to register the vaccine with the WHO’s Prequalification Program, which makes medicines available to agencies such as the UN Children’s Fund (UNICEF) and the Joint UN Program on HIV/AIDS (UNAIDS).
Shahid Jameel — group leader of the Virology Research Group at the Indian branch of the International Center for Genetic Engineering and Biotechnology, New Delhi — said the new Chinese vaccine would be particularly useful for people travelling to endemic countries, such as India and China, and for pregnant women in endemic regions.
“In the latter population, I believe it will save many lives, so it is an important development,” Jameel told SciDev.Net.
Scott Holmberg, chief of the Epidemiology and Surveillance Branch in the Division of Viral Hepatitis at the US government’s Centers for Disease Control and Prevention (CDC), said: “Given recent large outbreaks of hepatitis E in Sub-Saharan Africa, and the many pregnant women and infants under two years old who [have died] in those outbreaks, US CDC investigators are eager to find a vaccine that is effective in such outbreak situations.”