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.”
This article is reproduced with permission from the magazine Nature. The article was first published on October 30, 2012.
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Add CommentHepatitis E is no more a disease of developing countries alone. Hepatitis E was first recognised during an epidemic of hepatitis, which occurred in Kashmir Valley in 1978. The epidemic involved an estimated 52,000 cases of icteric hepatitis with 1700 deaths. The disease had unique clinical and epidemiological features. There was increased incidence and severity of the disease in pregnant women. Over the years, hepatitis E was identified as a major health problem in developing countries with unsafe water supplies and poor sanitary disposal.
Reply | Report Abuse | Link to thisHepatitis E virus (HEV) is a small, non-enveloped, single stranded RNA virus and is the sole member of the genus Hepevirus, in the family of Hepeviridae. HEV has considerable genomic diversity and four major genotypes of the virus have been identified.
Data from sero-surveys forced re-evaluation of the epidemiology of hepatitis E and gave an indirect indication to vocationally acquired HEV infections in industrialized countries. Soon, autochthonous hepatitis E was recognised as a clinical problem in such countries. Several animal species especially domestic swine, wild boar and wild deer were found to be reservoirs of hepatitis E virus genotype 3 & 4 in these countries. Human infections occur through intake of uncooked or undercooked meat of the infected animals and pig livers or sausages made from these livers and sold in supermarkets. Chronic hepatitis E resulting in rapidly progressive liver cirrhosis and end stage liver disease was described in organ transplant patients and those with other immunodeficiency states from many European countries. As reported, two recombinant hepatitis E virus vaccines have successfully undergone phase 3 trials. HEV 239 vaccine has been marketed in China.
We have come a long way about hepatitis E story over the past 30 years since first description of the Kashmir epidemic-1978. However, a number of important issues remain unanswered. These can be broadly divided into four categories namely: (i) introduction of improved assays to detect HEV infections; (ii) better understanding and answering of many perplexing issues about of the epidemiology of hepatitis E; (iii) develop treatment strategies for HEV infection and management plans for those with severe infections especially liver failure; (iv) development and implementation of effective preventive strategies especially HEV vaccine. As we proceed to fulfil the challenges imposed by HEV, a public health problem of global importance shall be eventually
conquered.