现实:接种乙肝疫苗已成全球共识

According to the media， the dead babies have all received vaccines from the same manufacturer. “Parents of the children suspected that the deaths were associated with the vaccines”. They aimed directly at the vaccine producer. After nearly a month’s investigation， the “Vaccine Accident” had a result for the stage which showed that in the vaccine accident， cases were of diversified clinical symptoms and lacked identity. The Chinese authoritative media Southern Daily reported： “On January 3， 2014， China Food and Drug Administration and National Health and Family Planning Commission jointly published the preliminary findings of the Hepatitis B vaccine accidents of Kangtai Company in Shenzhen and no quality problems of hepatitis B vaccine produced by Kangtai company has been found. It clearly showed that 9 of the 18 suspected cases had nothing to do with vaccination. And 8 suspected cases also had nothing to do with vaccination by preliminary judgment. After the completion of the autopsy， a final conclusion will be made. Another patient of a severe case has recovered and been discharged， but the abnormal reaction caused by vaccine （anaphylactic shock） cannot be excluded.” Wei Lai， vice-president of People’s Hospital of Peking University and director of Institute of Liver Disease of Peking University， said： “In terms of the hepatitis b vaccine itself， the results accord with the clinical practice of hepatitis b vaccine since it was born and the international experience in vaccination.”

据媒体报道，死亡病例均接受过同一厂家生产的疫苗，“家属怀疑孩子死亡与接种疫苗有关”，矛头直接指向了疫苗的生产者。经过近一个多月的调查，“疫苗事件”有了阶段性结果。结果证明在此次乙肝疫苗疑似致死事件中，病例呈多样化的临床表现，缺乏同一性。据中国权威媒体《南方日报》报道，“2014年1月3日，中国国家食药监总局、国家卫生计生委联合通报深圳康泰公司乙肝疫苗事件的初步调查结果。通报称，未发现康泰公司生产的乙肝疫苗存在质量问题；疑似因接种该疫苗出现异常反应的18例，其中9例已明确与接种疫苗无关，8例初步判断也与接种疫苗无关，有待尸检完成后作出最终结论；另有一例重症已康复出院，但不排除疫苗引起的异常反应（过敏性休克）。”“就乙型肝炎疫苗本身而言，该结果符合国际上乙型肝炎疫苗自诞生以来的临床实践和国际上对于疫苗的经验。”中国北京大学人民医院副院长、北京大学肝病研究所所长魏来说。

181 countries have included Hepatitis B vaccination into planned immunity

181个国家已将乙肝疫苗纳入计划免疫

The deaths of the infants by Hepatitis B vaccination do not only happen in China. The adverse reaction of vaccination is a common problem all over the world. According to the USA Vaccine Information Center， 1，259 persons died after Hepatitis B vaccination in the USA （30 persons per year） from 1991 to 2013， including 769 young children under 3.

It is not new to question the safety of Hepatitis B vaccine. In 1996， the French media reported that the Hepatitis B vaccine might be associated with the onset of multiple sclerosis. In addition， at the annual meeting of the American Association for Cancer Research， researchers said that acute lymphoblastic leukemia might be associated with Hepatitis B vaccine. In 2002， the Global Advisory Committee on Vaccine Safety of the World Health Organization （WHO） put forward that it was more likely a coincidence that Hepatitis B vaccination caused multiple sclerosis. Although a variety of questions emerge in an endless stream， we find no obvious evidence.

中国接种乙肝疫苗导致婴儿死亡的案例并非孤例，疫苗接种的不良反应是全世界面临的共同难题，根据美国疫苗信息中心的信息来看，从1991年-2013年，美国有1259人接种乙肝疫苗后死亡，其中3岁以内的婴幼儿有769人（年均30人）。

对于乙肝疫苗安全性的质疑，也早已不是新鲜事。其中影响最大的是1996年，法国媒体报道称乙肝疫苗可能与多发性硬化症的发病有关。另外，2002年，有研究人员在美国癌症研究协会年会上报告上表示，急性淋巴细胞白血病可能与接种乙肝疫苗有关。同样是在2002年，世界卫生组织的全球疫苗安全咨询委员会提出，接种乙肝疫苗与患上多发性硬化症之间属于巧合的关系更大。虽然各种质疑层出不穷，但没有发现与乙肝疫苗存在关联的明显证据。

Hepatitis B vaccine appeared in 1982. World Health Organization states that vaccination is the primary method to prevent Hepatitis B. Zhuang Hui， professor of Health Science Center of Peking University and academician of Chinese Academy of Engineering， mentioned that according to the statistics in 2013， 181 of the 195 WHO countries have added hepatitis B vaccine into planned Immunity. And 107 of the 181 countries require that babies have hepatitis B vaccination within 24 hours after birth. In the Western Pacific area， 95% children have hepatitis B vaccination within 24 hours after birth.

Since China included hepatitis B vaccine in Planned Immunity in 1992， children's infection rate decreased from 9.67% to 0.96%. The America's Center for Disease Control recommends that all infants should receive three doses of Hepatitis B vaccine from 12 hours to 18 months after birth to prevent Hepatitis B virus infection from mothers. In addition， countries like Ireland and Switzerland have very low rates of Hepatitis B， and they have taken the method of giving Hepatitis B vaccination only to high-risk groups.

乙肝疫苗出现于1982年，世界卫生组织认为，接种疫苗是预防乙肝的主要方法。中国北京大学医学部教授、中国工程院院士庄辉介绍，根据2013年的统计，世界卫生组织195个国家中有181个国家已将乙肝疫苗纳入计划免疫，其中107个国家要求新生儿在出生后24小时内接种乙肝疫苗，在西太地区95%的孩子于出生后24小时内接种乙肝疫苗。

中国自1992年将乙肝疫苗纳入计划免疫以来，儿童感染率从9.67%下降到0.96%。虽然有死亡病例的存在，美国疾控中心建议所有婴儿在出生后12个小时至18个月内接种三针乙肝疫苗，防止来自母体的乙肝病毒感染。此外，像爱尔兰、瑞士这种乙肝发病率极低的国家，一般采取对高危人群接种乙肝疫苗的做法。

Vaccination： the most successful intervention measure of public health recognized by the world

接种疫苗是全球公认的最成功的

公共卫生干预措施

Since the vaccination accident happened in China， a lot of people have become negative towards vaccination. Many parents even thought that their children should not be vaccinated in case accidents happen. Gao Lidong， deputy director and news spokesman of Disease Control Center in Hunan Province， said： “Based on relevant statistics， since the vaccination accident， the vaccination rate of Hepatitis B has decreased by 30%. Many parents have fallen into the dilemma whether to give their children the vaccination.”

The Internet is filled with parents’ concerns and questions about vaccination. “I’m afraid of giving vaccination to my baby.” “My baby has just received Hepatitis B vaccine. I’m getting worried for the safety of the vaccine.”… Actually， “vaccines， including Hepatitis B vaccine， are basically safe.” Li Lanjuan， an academician of the Chinese Academy of Engineering， says that the risks of having adverse reactions after receiving vaccination is far lower than the risks of the transmission of infectious diseases without receiving vaccination.

“伤不起的接种”、“能不打就不打”、“不打也没事”……自中国“疫苗事件”发生后，不少人对疫苗表现出了消极态度，很多家长甚至“谈苗色变”。据中国湖南疾控中心主任副主任、新闻发言人高立东介绍，根据相关统计，自“疫苗事件”发生后，中国乙肝疫苗接种率下降约30%，不少家长陷入要不要给孩子接种的纠结当中。

“我是不敢给我家宝宝打疫苗了。”、“我家宝宝刚刚接种了乙肝疫苗会不会有问题？”、“我现在都不知道该不该让孩子接受乙肝疫苗了”……打开网页，满屏尽是家长对接种乙肝疫苗的疑问和困惑。“包括乙肝疫苗在内，总体上来说，疫苗是安全的。”中国工程院院士、传染病学专家李兰娟认为，接种疫苗后出现不良反应的风险远远小于不开展预防接种而造成的传染病传播的风险。

In accordance with the operation procedures recommended by World Health Organization， as long as the child is free from contraindication， OPV， BCG and Hepatitis B vaccines should be given to children at birth. “Hepatitis B is mainly transmitted through mother-baby transmission， blood transmission and sexual transmission. Mother-baby transmission is the main reason of chronic hepatitis after being infected with Hepatitis B virus. The earlier people get infected with Hepatitis B virus， the greater rates of people would be to have Hepatitis B. Zhuang Hui， an academician of Chinese Academy of Engineering and professor of Peking University Health Science Center， said that according to researches， if the children born by mothers with Hepatitis B virus are vaccinated， the rate of failing to stop the mother-baby transmission is only 4%. Professor Jia Jidong， director of Beijing Friendship Hospital Liver Research Center affiliated with Chinese Capital Medical University， said that in terms of the effects of Hepatitis B vaccines， the vaccination time of new born child should be “the earlier， the better”.

World Health Organization pointed out that vaccination is one of the most successful and effective intervention measures of public health recognized by the world. The risks of children getting diseases will be greatly decreased on the condition that children get vaccination at an early time. According to a research by a relevant organization made in 1992， the rate of Hepatitis B virus carriers under 15 of the whole population in China is about 10%. The number has decreased to 3% since the adoption of Hepatitis B vaccination in 2002. World Health Organization issued a report saying： “China has made the right decision. The methods of vaccination to all babies to control Hepatitis B have decreased the infection rate of chronicle Hepatitis B from nearly 10% to below 1%.”

In 1982， regular Hepatitis B vaccine was recommended to adults and children in America. In 1991， regular Hepatitis B vaccine was given to all American children. It is reported that since the adoption of Hepatitis B vaccination in 1990， the infection rate of Hepatitis B of American children and teenagers have dropped by 95%.

按照世界卫生组织推荐的操作规程，只要没有禁忌症，糖丸、卡介苗、乙肝疫苗都应在孩子出生就要服用或注射。“因为乙肝主要经母婴传播、血液传播和性接触传播，母婴传播是乙型病毒感染后发生慢性乙肝的主要原因，感染乙肝病毒越早发生慢性乙肝的比例越多，新生儿时期感染更易发生慢性乙肝。”中国工程院院士、北京大学医学部教授庄辉表示，调查显示，乙肝病毒表面抗原阳性、E抗原阳性母亲所生的婴儿在24小时内接种乙肝疫苗者，不能阻断母婴传播的比率仅为4%。中国首都医科大学附属北京友谊医院肝病研究中心主任贾继东教授也表示，单就乙肝疫苗的预防效果而言，新生儿接种的时间确实是“越早越好”。

世卫组织曾指出，接种疫苗是全球公认的最成功和最经济有效的公共卫生干预措施之一。儿童期接种某种疫苗，不能百分之百保证孩子不得相应的病，但却可以最大限度降低患病风险。据1992年的有关机构的调查表明，中国15岁以下人群的乙肝病毒携带率约为10%，2002年乙肝疫苗纳入计划免疫后，这一人群的乙肝病毒携带率已降到3%。世界卫生组织曾发表报告称“中国做出了正确的决策，通过为所有婴儿接种乙肝疫苗来控制乙肝，使中国5岁以下儿童慢性乙肝病毒感染率从近10%降至目前的1%以下”。

在美国，1982年，常规乙肝疫苗就被推荐给美国成人和儿童接种，到1991年时，常规乙肝疫苗已普及到所有美国儿童。据报道，自接种乙肝疫苗之后从1990年至今，美国儿童和青少年的乙肝感染率下降了95%。

Then how to explain the death cases？ The monitoring information management system of Adverse Events Following Immunization has given the following explanation： “From 2005 to 2009， there were 2836 cases of suspected abnormal reactions to vaccination （about 0.016%）. There are many kinds of adverse reactions after Hepatitis B vaccination. The rate of ordinary reactions which do not involve clinic treatment is 74.26%. The rate of coupling reaction not related to vaccination is 4.76%. Fewer cases are caused by vaccination negligence and other unclear reasons.” From this， we can see that the rate of abnormal reactions of vaccination is very low and there are coupling reactions. WHO concluded the events of adverse reactions of vaccination by saying： “Reality is always not perfect”.

A lot of foreign experience shows that once the public misunderstands and opposes vaccination， risks will be easily triggered. Cheng Feng， an epidemiological researcher of School of Public Health of Tsinghua University， said that in 1974， after the DPT vaccination， there were 36 cases of adverse reactions of nervous system in England. Consequently， the vaccination rate dropped sharply from 81% to 31%. However， the morbidity rose by 200 times. There was an outbreak of pertussis.

那又如何解释那么多的伤亡病例呢？中国疑似预防接种异常反应（AEFI）监测信息管理系统给出了这样的解释：“2005年-2009年，疑似预防接种异常反应共有2836例（约占0.016%）。乙肝疫苗接种后不良反应类型很多，不需要临床治疗的一般反应占74.26%；与接种无关的偶合反应占4.76%；还有较少情形是心因性反应、接种事故、不明原因等。”从这个解释中我们可以看出，接种异常反应的概率很低，且有偶合反应的存在，而世界卫生组织对预防接种不良事件进行总结时也表示：“现实总非完美”。

不少国外经验表明，社会公众一旦因为误解而抵制疫苗接种，极易引发风险。清华大学公共健康中心流行病学研究员程峰介绍，1974年英国有报道称接种百白破疫苗后发生36起神经系统不良反应，接种率从81%大幅降至31%，导致发病率上升200倍，暴发百日咳疫情。

Actions for preventing abnormal reactions of vaccination in various countries： guaranteeing quality before accidents and making compensation after accidents

各国预防接种异常反应行动：

事前保质，事后赔偿

French writer Roger Martin Du Jiaer said： “Nothing is more precious than life and life is inconceivably short.” The life of a child is priceless. No matter how much money cannot compensate the pains of parents. In order to appropriately deal with the abnormal reactions of vaccination， various countries in the world have adopted their own methods.

Currently， many countries have made special legislations for preventing abnormal reaction of vaccination. In 1986， the US drew up National Vaccine Injury Act for Children which stipulates that the victims of vaccination can get compensations of at most 250，000 dollars based on the degrees of injury within 6 months of the accident （or within two years of the death of the victim）. As early as in 1997， Japan formulated the remedy system for preventing injury of vaccination. If people get sick because of vaccination， they can apply for compensations of medical fee and some subsidies. If there are severe cases of handicap or death， people can apply for the survivor annuity or one-time compensation and funeral expenses. In 2006， the Chinese government also formulated The Ordinance on the Management of Vaccine and Immunization which stipulated that for those severely damaged， one-time compensation should be given. The specific compensation methods are formulated by the governments of provinces， autonomous regions and municipalities directly under the Central Government. The compensation of abnormal reactions caused by the first kind of vaccines should be taken by provincial financial departments. The compensation of abnormal reactions caused by the second kind of vaccines should be taken by producers.

法国作家杜伽尔说过：“没有比生命更宝贵的东西，生命想像不到地短暂。”孩子的生命无价，再多的钱财也无法弥补父母的伤痛。为了妥善应对疫苗接种带来的异常反应，世界各国采取了不同的处理办法。

目前，不少国家对预防接种异常反应补偿进行了专门立法。1986年，美国制定了《国家儿童疫苗损害法案》。法案规定，疫苗受害者在受害6个月后（或受害者死亡2年内），根据伤害程度的不同，疫苗受害者最高可以获得25万美元的赔偿。早在1977年，日本就制定了预防接种健康被害救济制度。接种疫苗者若出现后遗症导致住院，可申请医疗费外加一定补助；如果出现身体残障甚是死亡等严重情况，可申请获得遗属年金或一次性补偿及丧葬费等。2005年，中国政府也了《疫苗流通和预防接种管理条例》，条例规定：“对因异常反应引起的严重损害者给予一次性补偿，具体补偿办法由省、自治区、直辖市人民政府制定，属于一类疫苗引起的预防接种异常反应的补偿费用由省级财政安排，属于二类疫苗引起的预防接种异常反应的补偿费用由生产企业承担。”

Besides compensation， each country has also tried their best to lower the rates of adverse reactions. The English government requires that vaccines should have a quality and effectiveness test before going to market. The test involves two levels. The first level is a self-test of the producers. The second level is that one of the official drug laboratories recognized by European Union should run the test again. The vaccine can go to the market only after passing the tests.

In order to ensure the safety of vaccines， Germany’s special vaccine trucks are made of special materials that prevent light and have good sealing performance except the cabs. In addition， each truck has functions of heat proof， static electricity proof and radiation proof. There are security guards on each truck. After the vaccines are transported to the vaccine company of each state， they are stored in specialized vaccine warehouses. The storage cabinet is of variable temperature and thus the temperature can be adjusted according to the different requirements of different vaccines.

Japan has continuously improved its monitoring organization and has added physicians and specialists from the third party. In actual operation， the producer should report the adverse reaction of the vaccines it produced rather than use the so-called “safety ratio”.

Since the founding of the People’s Republic of China， the Chinese government has adhered to the policy of “prevention first and combining prevention with control”， and has increased the efforts of preventing and controlling infectious diseases. In 2009， Chinese disease control departments at all levels started to give free vaccination to those who have not received Hepatitis B vaccination under the age of 15. China Business reported that in accordance with the Implementation Plan of Expanding National Immunization Plan issued by the original Ministry of Health in 2007， Hepatitis B vaccination should be done in three doses which are at the birth of the child， one month old and six months old. The first dose should be done within 24 hours of the birth of a child.

除了赔偿外，各国也在为减少疫苗不良反应竭尽全力。英国政府要求疫苗在上市前必须进行质量和有效性检测。检测分两个层次，第一个层次为生产商自测，第二层次则由欧盟认可的几家官方药品检测实验室其中的一家再次检测，只有通过检测才能获批入市。

为保证疫苗的安全，德国的疫苗专用运输车除驾驶室外，全部采用避光、密封性能好的特殊材料制成，且每辆车都有防热、防静电、防辐射等功能。同时，每车还配有安保人员，运输车将疫苗运到各州的疫苗公司后，会被放入专门的疫苗仓库。而存放疫苗的变温储藏柜可根据每种疫苗的不同需要进行温度调节。

日本不断完善不良反应监测机构，增加第三方医师和专家。在实际操作过程中，生产企业应报告所生产的疫苗发生的所有不良反应，而不采用所谓的“安全比率”。

新中国成立以来，中国政府坚持“预防为主，防治结合”方针，不断加大传染病防治力度，2002年，中国将新生儿Hepatitis B疫苗纳入国家免疫规划，国家免疫规划由接种4种疫苗预防6种传染病，扩大到接种5种疫苗预防7种传染病。2009年起，中国各级疾控部门开始对15岁以下未接种过Hepatitis B免疫的人群，免费补种Hepatitis B疫苗。据《中国经营报》报道，按照2007年原卫生部的扩大国家免疫规划实施方案，Hepatitis B疫苗明确规定应接种3剂次，分别是在儿童出生时、1月龄、6月龄，其中第1剂应在“出生后24小时内尽早接种”。