Zhang points out that UK drug-maker GlaxoSmithKline had already developed a separate hepatitis E vaccine in collaboration with the US Army, which showed promise in phase II trials. But with hepatitis E mostly occurring in developing countries, there was little commercial potential for the vaccine. “This is true not just of hepatitis E, but also many other plagues in the world,” says Zhang.
Medical products for conditions such as hepatitis E that predominantly affect the developing world “are not seen as big money opportunities”, agrees Jeremy Farrar, director of the Oxford University Clinical Research Unit in Ho Chi Minh City, Vietnam. “New companies operating with different funding models offer a great opportunity, and one which could have a profound impact.”
Hecolin may have arrived just in time to tackle a rise in hepatitis E in Africa, where a 2007 outbreak in Uganda infected more than 10,000 people and killed 160. By the end of September this year, more than 200 cases of jaundice caused by hepatitis E had been reported in refugee camps in Kenya since August, and three refugee camps in South Sudan have seen 16 deaths and 400 cases of hepatitis E infection since July. “Cases are rising day by day, thus placing immense pressure on the available health services and resources. This is of grave humanitarian concern,” said South Sudan’s health ministry in a statement in September.
Xiamen University and Innovax are in talks with the World Health Organization (WHO) to register Hecolin with the organization’s Prequalification Programme, which makes medicines available to agencies such as the United Nations Children’s Fund and the Joint UN Programme on HIV/AIDS. “We have to be sure that these vaccines can be used anywhere,” says Farrar. “It would be a great shame if these products were not available outside China.”
“We have to accept that companies such as this one in China are going to be very important in the future,” he adds. “The rest of us have to catch up. We need to find a way, through the WHO, of ensuring the absolute transparency, safety and effectiveness of their vaccines.”