Yikoning, the world's first hepatitis E vaccine developed in China, will go on the market in October

Behind the development of the world's first hepatitis E vaccine China is a high prevalence area of hepatitis E, but the public's understanding of hepatitis E is relatively low, and the harm of hepatitis E is seriously underestimated It is expected that in October this year, "yikoning", the hepatitis E vaccine originally developed and produced in China, will be commercialized This is the world's first hepatitis E vaccine that can directly benefit all mankind "Yikoning" was developed by the National Center for infectious disease diagnostic reagents and vaccine engineering technology of Xiamen University The research and development took about 14 years, and the R & D investment reached about 500 million yuan "China should be praised for the first licensed hepatitis E vaccine in developing countries," said World Health Organization communications director Sergei chagwich Shagwich's words correspond to the severe situation of hepatitis E Only in China, the incidence rate and mortality rate of hepatitis E in China are increasing rapidly According to the data of the national infectious diseases epidemic issued by the Ministry of health monthly, the incidence of hepatitis E in the first half of 2012 exceeded the incidence rate of hepatitis A for the first time, becoming the biggest killer of acute epidemic hepatitis in China Wu Ting, an associate professor at the school of public health of Xiamen University, who is engaged in the study of hepatitis E, told the journal that because of the lag in the research of etiology diagnosis, the harm of hepatitis E is seriously underestimated and it has become a neglected disease What role will "yikening" play in the prevention and control of hepatitis E? Neglected hepatitis E Hepatitis E is an acute viral hepatitis caused by hepatitis E virus infection Generally speaking, hepatitis caused by virus can be divided into five types: A, B, C, D and E Among them, the discovery of hepatitis E was the latest Before 1989, it had been called non-A, non-B hepatitis Hepatitis E virus is one of the least known and most complex pathogenic viruses Among at least four genotypes of hepatitis E virus, type 1 and type 2 mainly infect human beings, while type 3 and type 4 are zoonotic viruses, with pigs as the main host The first recorded case of hepatitis E occurred in 1955 At that time, flooding in New Delhi, India, the Jamuna river diversion and urban sewage pollution, led to a major outbreak, the number of patients in a short period of time increased dramatically, causing panic among the local people The epidemic lasted until 1956, with more than 97000 cases recorded Limited to the medical level at that time, it was generally believed that hepatitis A was the main cause of the hepatitis pandemic, but some scholars involved in the epidemic investigation raised doubts In 1989, Dr Reyes of the United States and other scientists successfully cloned the genome of hepatitis E virus by using molecular biology technology In September of the same year, at the International Conference on non-A, non-B hepatitis and blood borne infectious diseases held in Tokyo, Japan, the pathogen causing the outbreak of hepatitis in New Delhi was officially named hepatitis E virus Since then, large-scale outbreaks of hepatitis E have occurred in Kathmandu of Nepal, Mandalay of Myanmar, Xinjiang of China, Somalia, Sudan, Uganda of Africa, Sri Lanka of South Asia, etc According to a World Health Organization data on "viral hepatitis in Southeast Asia", there are 14 million clinical hepatitis E patients worldwide every year, with 300000 deaths each year and 5200 fetal deaths At present, about one third of the world's population has been infected with hepatitis E virus Virology experts found that the prevalence of hepatitis E in developing countries with poor health conditions has changed in the past In the past 10 years, sporadic cases of hepatitis E have been reported in the United States, Europe and developed countries in Asia Pacific region, such as Japan and Australia, among which only a few cases are imported and the vast majority are local According to the statistics of the World Health Organization, our country belongs to the high epidemic area of hepatitis E However, the public's understanding of hepatitis E is relatively low Gao Yongzhong, general manager of Wantai Canghai Biotechnology Co., Ltd., said that the elderly would generally have a certain impression of the outbreak of hepatitis A in Shanghai in 1989, but they did not know about the outbreak of hepatitis E in Hetian, Kashi and Kizilsu Prefecture of Xinjiang from September 1986 to April 1988 The outbreak involved 23 counties and cities, with a total of about 120000 cases and 707 deaths (including 414 pregnant women), making it the largest hepatitis E epidemic in the world so far No matter in scale, time span, involved area and harmfulness, it is much more serious than the hepatitis A epidemic in Shanghai in the same period Our reporter also found in the interview that many people who asked randomly, even some people with higher education, often have no concept of hepatitis E some people even think that hepatitis E is a disease of disaster and poverty in Africa, which has nothing to do with China Rapid rise of hepatitis E In fact, the incidence rate of hepatitis E is rapidly increasing in China According to the statistics of the Ministry of health, in June this year, the number of hepatitis A patients in China was 12778, and the number of hepatitis E patients was 16396 The number of hepatitis E patients exceeded the number of hepatitis A patients by 3618 This is the first breakthrough since statistics of the Ministry of health Analysis of the epidemic report of the Ministry of health shows that the annual incidence of hepatitis A in China has decreased from 99383 in 2003 to 31456 in 2011, a decrease of 216% At the same time, the number of patients with hepatitis E increased year by year, from 9655 in 2003 to 29202 in 2011, an increase of 202% Zhang Jun, deputy director of the National Center for infectious disease diagnostic reagents and vaccine engineering technology, told our reporter that misdiagnosis and missed diagnosis of hepatitis E cases are very common in clinical practice The existing statistics of hepatitis E cases are just the tip of the iceberg Zhang Jun said that in 2011, the amount of hepatitis E testing reagents used was 7 million, only one fifth of that of hepatitis A, but the number of cases detected was almost equal to that of hepatitis A In many places, because it is difficult to find out the exact cause, a considerable number of hepatitis E cases are misdiagnosed as drug hepatitis or alcoholic hepatitis Our reporter has learned that hepatitis E is mainly transmitted through the digestive tract, and the virus often infects people through the pollution of daily life water and food In recent years, studies have found that hepatitis E can also be transmitted through blood and mother infant vertical transmission The outbreak of hepatitis E in Uganda in 2007 also saw cases of contact transmission Other studies have confirmed that pigs are one of the main sources of hepatitis E virus infection in China Eating raw or semi cooked animal meat products and seafood may be infected Generally speaking, the epidemic of hepatitis E usually occurs after the rainy season or flood, and winter and spring are the high incidence seasons in China Heavy rain, flood and other frequent extreme weather are particularly easy to cause the outbreak of hepatitis E the occurrence of earthquakes, droughts and other natural disasters can also aggravate the prevalence and distribution of hepatitis E Patients and pigs with virus are the main source of infection The amount of virus discharged from feces at the end of latent period and acute period is the highest, and the infectivity is the strongest The clinical symptoms of hepatitis E are similar to those of hepatitis A, but the symptoms are more severe, usually manifested as jaundice, fever, fatigue, loss of appetite, etc the severe patients will have digestive tract symptoms such as extreme fatigue, nausea, vomiting, etc., and they will not have a clear consciousness, liver failure or even death Hepatitis E is more harmful to women of childbearing age, patients with chronic liver disease, the elderly and infants Pregnant women infected with hepatitis E are prone to miscarriage, premature delivery and stillbirth Pregnant women infected with hepatitis E can be transmitted vertically from mother to infant, causing hepatitis E or death of newborn One third of pregnant women infected with hepatitis E have severe hepatitis, with a mortality rate of 20% 44% of the patients with chronic liver diseases such as hepatitis B, chronic hepatitis C, fatty liver, alcoholic liver and cirrhosis had the risk of superinfection of hepatitis E The mortality rate after infection was as high as 75% In China, hepatitis E is mainly acute sporadic cases, but also small outbreaks caused by food pollution According to statistics from Ministry of health, the incidence rate of hepatitis E has been the first in adult acute viral hepatitis Hepatitis E is more prone to severe hepatitis and liver failure than hepatitis A, and the degree of harm is far higher than that of hepatitis A The data showed that the mortality rate of hepatitis E also increased rapidly to the top of all types of viral hepatitis, which was 10 times higher than that of hepatitis A According to the national legal epidemic situation of infectious diseases issued by the Ministry of health, the death toll of hepatitis E increased by 44.44% and 11.54% respectively in 2010 and 2011 Wang Zhao, former director of the Department of disease control of the Ministry of health, believed that due to social development, scientific and technological progress, improvement of living conditions and other factors, similar to the hepatitis E pandemic in Xinjiang may not repeat, but many regions and high-risk groups still have the potential risk of hepatitis E infection and transmission, or even small outbreaks, and improper diagnosis and treatment may lead to serious life-threatening consequences Therefore, we should keep enough vigilance to hepatitis E, change neglect to pay attention to it, and take it seriously as a major public health problem "Major breakthrough" in prevention and control of hepatitis E As there is no specific treatment for hepatitis E infection in the world, the development of effective prevention vaccine has become the best choice The National Institutes of health of the United States and GlaxoSmithKline, the world vaccine industry giant, took the lead in the development of recombinant hepatitis E vaccine, and carried out the first phase of clinical trials in the Nepalese Army soldiers from 2000 to 2004 and achieved success When the relevant fields all over the world thought they saw hope, GlaxoSmithKline, which owns the intellectual property rights of hepatitis E vaccine, stopped abruptly Some insiders believe that the reason for further clinical trials to stop is that the company considers the insect cell expression system it uses to be expensive due to commercial value considerations GlaxoSmithKline has been silent up to now in the face of public doubts from relevant authorities in the international community In 1998, Chinese researchers began to study diagnostic reagents for hepatitis E The "yikoning" mentioned above is the original hepatitis E vaccine developed and produced in China, and the first hepatitis E vaccine that can directly benefit the whole human being in the world The vaccine was developed by the National Center for infectious disease diagnostic reagents and vaccine engineering technology of Xiamen University for 14 years with an investment of about 500 million yuan In June 2012, Xiamen Wantai Canghai Biotechnology Co., Ltd., which implemented the vaccine transformation, passed the relevant GMP certification of the State Food and drug administration, and successfully completed all administrative approvals before the commercialization and listing It is reported that the world's first vaccine for the prevention of hepatitis E has carried out the first phase of clinical trials in Dongtai City, Yancheng City, Jiangsu Province, a high prevalence area of hepatitis E virus in China, with a time span of nearly two years (August 2007 June 2009) and nearly 100000 participants It is the largest clinical trial of vaccine in the world so far The results of the first phase of clinical trial showed that the vaccine had an ideal protective effect on vaccinated volunteers The successful development of hepatitis E vaccine in China has won wide praise from academic and industrial circles at home and abroad The world's top medical journals and international authoritative journals sponsored by the World Health Organization reported the achievement, and believed that "this is a major breakthrough in the field of hepatitis E prevention and control in the world" Industry insiders told our reporter that the successful development of the world's first hepatitis E vaccine in China and its real commercialization have multiple meanings First, it provides an effective active prevention tool for hepatitis E for the first time, which can be regarded as a major breakthrough in the field of hepatitis E prevention and control in the world Second, it breaks the conclusion of the international pharmaceutical community and uses E.coli as the expression system, The fourth research and development path of genetically engineered vaccine, which is parallel to yeast, insect cells and mammalian cells, is created independently; third, it is in the process of research and development