From Nature magazine.

Batches of the world’s first vaccine against the hepatitis E virus began rolling out of a Chinese factory last week, promising to stem a disease that every year infects about 20 million people and claims 70,000 lives. The vaccine is being hailed as a victory for an unusual public–private partnership that could set a precedent in China’s burgeoning biotechnology sector, and help to deliver other vaccines for diseases overlooked in the West.

The waterborne hepatitis E virus mostly occurs in developing countries that have poor sanitation, and it is particularly prevalent in east and south Asia. Although most cases cause only mild illness, it can lead to acute liver failure — the mortality rate reaches 4% in some regions and soars to 20% in women who are in the later stages of pregnancy. A severe outbreak of hepatitis E in the Xinjiang Uygur Autonomous Region in northwest China, for example, caused almost 120,000 infections and more than 700 deaths between 1986 and 1988 (see ‘Hidden epidemics’). There is no treatment, and improved sanitation has so far been the most effective way to stem the disease.

Sources: J. M. Hughes et al. Clin. Infect. Dis. 51, 328–334 (2010)/who/Promed-mail

The new vaccine, which was approved by China’s State Food and Drug Administration (SFDA) in December 2011, could transform that picture. More than a decade ago, researchers at Xiamen University in Fujian province genetically modified a strain of the bacterium Escherichia coli to produce a protein that, when injected into humans, stimulates the body’s immune system against hepatitis E. But preclinical and clinical development began in earnest only in 2000, when the Yangshengtang Group, a company with interests in food and health care, invested 15 million renminbi (US$1.8 million in 2000) to set up a joint biotech laboratory in partnership with the university. The lab was given national status in 2006 by the Chinese Ministry of Science and Technology and relaunched as the National Institute of Diagnostics and Vaccine Development in Infectious Diseases (NIDVD).

The institute aims to unite academia and industry in commercializing new vaccines, particularly for emerging infectious diseases. Yangshengtang set up a subsidiary company called Innovax to take potential vaccines through clinical trials to manufacturing. The hepatitis E vaccine, Hecolin, is the company’s first product to reach the market, but it also has a vaccine against human papilloma virus that is currently in preclinical research. Approval for Hecolin came after a phase III clinical trial published in 2010 showed that it was highly effective in preventing infection among almost 100,000 healthy participants.

Hecolin cost about 500 million renminbi (US$80 million) to develop, much of which came from the Chinese government through the university. The vaccine will be sold to distributors in China at a cost of 110 renminbi per dose, and the company expects it to reach sales of 62 million renminbi in 2013. That is hardly a blockbuster income, but, according to Jun Zhang, deputy director of the NIDVD, the public–private development model helps to ensure that vital vaccines are developed regardless of whether they prove to be profitable for manufacturers.

Zhang hopes that the success of Hecolin will attract further investment in such schemes, and says that the Chinese government has been encouraging. “Many people — including representatives of multinational pharmaceutical companies, venture capitalists, Chinese local government officials and Chinese entrepreneurs — think this is a worthy example of biotechnology investment,” he says.

1 Comments

1. 1. khuroo 01:48 PM 11/8/12

   Hepatitis 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.
   
   Hepatitis 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.

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