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.”

據(jù)媒體報(bào)道，死亡病例均接受過(guò)同一廠(chǎng)家生產(chǎn)的疫苗，“家屬懷疑孩子死亡與接種疫苗有關(guān)”，矛頭直接指向了疫苗的生產(chǎn)者。經(jīng)過(guò)近一個(gè)多月的調(diào)查，“疫苗事件”有了階段性結(jié)果。結(jié)果證明在此次乙肝疫苗疑似致死事件中，病例呈多樣化的臨床表現(xiàn)，缺乏同一性。據(jù)中國(guó)權(quán)威媒體《南方日?qǐng)?bào)》報(bào)道，“2014年1月3日，中國(guó)國(guó)家食藥監(jiān)總局、國(guó)家衛(wèi)生計(jì)生委聯(lián)合通報(bào)深圳康泰公司乙肝疫苗事件的初步調(diào)查結(jié)果。通報(bào)稱(chēng)，未發(fā)現(xiàn)康泰公司生產(chǎn)的乙肝疫苗存在質(zhì)量問(wèn)題；疑似因接種該疫苗出現(xiàn)異常反應(yīng)的18例，其中9例已明確與接種疫苗無(wú)關(guān)，8例初步判斷也與接種疫苗無(wú)關(guān)，有待尸檢完成后作出最終結(jié)論；另有一例重癥已康復(fù)出院，但不排除疫苗引起的異常反應(yīng)（過(guò)敏性休克）。”“就乙型肝炎疫苗本身而言，該結(jié)果符合國(guó)際上乙型肝炎疫苗自誕生以來(lái)的臨床實(shí)踐和國(guó)際上對(duì)于疫苗的經(jīng)驗(yàn)?！敝袊?guó)北京大學(xué)人民醫(yī)院副院長(zhǎng)、北京大學(xué)肝病研究所所長(zhǎng)魏來(lái)說(shuō)。

181 countries have included Hepatitis B vaccination into planned immunity

181個(gè)國(guó)家已將乙肝疫苗納入計(jì)劃免疫

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.

中國(guó)接種乙肝疫苗導(dǎo)致嬰兒死亡的案例并非孤例，疫苗接種的不良反應(yīng)是全世界面臨的共同難題，根據(jù)美國(guó)疫苗信息中心發(fā)布的信息來(lái)看，從1991年-2013年，美國(guó)有1259人接種乙肝疫苗后死亡，其中3歲以?xún)?nèi)的嬰幼兒有769人（年均30人）。

對(duì)于乙肝疫苗安全性的質(zhì)疑，也早已不是新鮮事。其中影響最大的是1996年，法國(guó)媒體報(bào)道稱(chēng)乙肝疫苗可能與多發(fā)性硬化癥的發(fā)病有關(guān)。另外，2002年，有研究人員在美國(guó)癌癥研究協(xié)會(huì)年會(huì)上報(bào)告上表示，急性淋巴細(xì)胞白血病可能與接種乙肝疫苗有關(guān)。同樣是在2002年，世界衛(wèi)生組織的全球疫苗安全咨詢(xún)委員會(huì)提出，接種乙肝疫苗與患上多發(fā)性硬化癥之間屬于巧合的關(guān)系更大。雖然各種質(zhì)疑層出不窮，但沒(méi)有發(fā)現(xiàn)與乙肝疫苗存在關(guān)聯(lián)的明顯證據(jù)。

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.

乙肝疫苗出現(xiàn)于1982年，世界衛(wèi)生組織認(rèn)為，接種疫苗是預(yù)防乙肝的主要方法。中國(guó)北京大學(xué)醫(yī)學(xué)部教授、中國(guó)工程院院士莊輝介紹，根據(jù)2013年的統(tǒng)計(jì)，世界衛(wèi)生組織195個(gè)國(guó)家中有181個(gè)國(guó)家已將乙肝疫苗納入計(jì)劃免疫，其中107個(gè)國(guó)家要求新生兒在出生后24小時(shí)內(nèi)接種乙肝疫苗，在西太地區(qū)95%的孩子于出生后24小時(shí)內(nèi)接種乙肝疫苗。

中國(guó)自1992年將乙肝疫苗納入計(jì)劃免疫以來(lái)，兒童感染率從9.67%下降到0.96%。雖然有死亡病例的存在，美國(guó)疾控中心建議所有嬰兒在出生后12個(gè)小時(shí)至18個(gè)月內(nèi)接種三針乙肝疫苗，防止來(lái)自母體的乙肝病毒感染。此外，像愛(ài)爾蘭、瑞士這種乙肝發(fā)病率極低的國(guó)家，一般采取對(duì)高危人群接種乙肝疫苗的做法。

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

接種疫苗是全球公認(rèn)的最成功的

公共衛(wèi)生干預(yù)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.

“傷不起的接種”、“能不打就不打”、“不打也沒(méi)事”……自中國(guó)“疫苗事件”發(fā)生后，不少人對(duì)疫苗表現(xiàn)出了消極態(tài)度，很多家長(zhǎng)甚至“談苗色變”。據(jù)中國(guó)湖南疾控中心主任副主任、新聞發(fā)言人高立東介紹，根據(jù)相關(guān)統(tǒng)計(jì)，自“疫苗事件”發(fā)生后，中國(guó)乙肝疫苗接種率下降約30%，不少家長(zhǎng)陷入要不要給孩子接種的糾結(jié)當(dāng)中。

“我是不敢給我家寶寶打疫苗了?！薄ⅰ拔壹覍殞殑倓偨臃N了乙肝疫苗會(huì)不會(huì)有問(wèn)題？”、“我現(xiàn)在都不知道該不該讓孩子接受乙肝疫苗了”……打開(kāi)網(wǎng)頁(yè)，滿(mǎn)屏盡是家長(zhǎng)對(duì)接種乙肝疫苗的疑問(wèn)和困惑?！鞍ㄒ腋我呙缭趦?nèi)，總體上來(lái)說(shuō)，疫苗是安全的?！敝袊?guó)工程院院士、傳染病學(xué)專(zhuān)家李蘭娟認(rèn)為，接種疫苗后出現(xiàn)不良反應(yīng)的風(fēng)險(xiǎn)遠(yuǎn)遠(yuǎn)小于不開(kāi)展預(yù)防接種而造成的傳染病傳播的風(fēng)險(xiǎn)。

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%.

按照世界衛(wèi)生組織推薦的操作規(guī)程，只要沒(méi)有禁忌癥，糖丸、卡介苗、乙肝疫苗都應(yīng)在孩子出生就要服用或注射?！耙?yàn)橐腋沃饕?jīng)母嬰傳播、血液傳播和性接觸傳播，母嬰傳播是乙型病毒感染后發(fā)生慢性乙肝的主要原因，感染乙肝病毒越早發(fā)生慢性乙肝的比例越多，新生兒時(shí)期感染更易發(fā)生慢性乙肝?！敝袊?guó)工程院院士、北京大學(xué)醫(yī)學(xué)部教授莊輝表示，調(diào)查顯示，乙肝病毒表面抗原陽(yáng)性、E抗原陽(yáng)性母親所生的嬰兒在24小時(shí)內(nèi)接種乙肝疫苗者，不能阻斷母嬰傳播的比率僅為4%。中國(guó)首都醫(yī)科大學(xué)附屬北京友誼醫(yī)院肝病研究中心主任賈繼東教授也表示，單就乙肝疫苗的預(yù)防效果而言，新生兒接種的時(shí)間確實(shí)是“越早越好”。

世衛(wèi)組織曾指出，接種疫苗是全球公認(rèn)的最成功和最經(jīng)濟(jì)有效的公共衛(wèi)生干預(yù)措施之一。兒童期接種某種疫苗，不能百分之百保證孩子不得相應(yīng)的病，但卻可以最大限度降低患病風(fēng)險(xiǎn)。據(jù)1992年的有關(guān)機(jī)構(gòu)的調(diào)查表明，中國(guó)15歲以下人群的乙肝病毒攜帶率約為10%，2002年乙肝疫苗納入計(jì)劃免疫后，這一人群的乙肝病毒攜帶率已降到3%。世界衛(wèi)生組織曾發(fā)表報(bào)告稱(chēng)“中國(guó)做出了正確的決策，通過(guò)為所有嬰兒接種乙肝疫苗來(lái)控制乙肝，使中國(guó)5歲以下兒童慢性乙肝病毒感染率從近10%降至目前的1%以下”。

在美國(guó)，1982年，常規(guī)乙肝疫苗就被推薦給美國(guó)成人和兒童接種，到1991年時(shí)，常規(guī)乙肝疫苗已普及到所有美國(guó)兒童。據(jù)報(bào)道，自接種乙肝疫苗之后從1990年至今，美國(guó)兒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.

那又如何解釋那么多的傷亡病例呢？中國(guó)疑似預(yù)防接種異常反應(yīng)（AEFI）監(jiān)測(cè)信息管理系統(tǒng)給出了這樣的解釋?zhuān)骸?005年-2009年，疑似預(yù)防接種異常反應(yīng)共有2836例（約占0.016%）。乙肝疫苗接種后不良反應(yīng)類(lèi)型很多，不需要臨床治療的一般反應(yīng)占74.26%；與接種無(wú)關(guān)的偶合反應(yīng)占4.76%；還有較少情形是心因性反應(yīng)、接種事故、不明原因等?！睆倪@個(gè)解釋中我們可以看出，接種異常反應(yīng)的概率很低，且有偶合反應(yīng)的存在，而世界衛(wèi)生組織對(duì)預(yù)防接種不良事件進(jìn)行總結(jié)時(shí)也表示：“現(xiàn)實(shí)總非完美”。

不少?lài)?guó)外經(jīng)驗(yàn)表明，社會(huì)公眾一旦因?yàn)檎`解而抵制疫苗接種，極易引發(fā)風(fēng)險(xiǎn)。清華大學(xué)公共健康中心流行病學(xué)研究員程峰介紹，1974年英國(guó)有報(bào)道稱(chēng)接種百白破疫苗后發(fā)生36起神經(jīng)系統(tǒng)不良反應(yīng)，接種率從81%大幅降至31%，導(dǎo)致發(fā)病率上升200倍，暴發(fā)百日咳疫情。

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

各國(guó)預(yù)防接種異常反應(yīng)行動(dòng)：

事前保質(zhì)，事后賠償

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.

法國(guó)作家杜伽爾說(shuō)過(guò)：“沒(méi)有比生命更寶貴的東西，生命想像不到地短暫。”孩子的生命無(wú)價(jià)，再多的錢(qián)財(cái)也無(wú)法彌補(bǔ)父母的傷痛。為了妥善應(yīng)對(duì)疫苗接種帶來(lái)的異常反應(yīng)，世界各國(guó)采取了不同的處理辦法。

目前，不少?lài)?guó)家對(duì)預(yù)防接種異常反應(yīng)補(bǔ)償進(jìn)行了專(zhuān)門(mén)立法。1986年，美國(guó)制定了《國(guó)家兒童疫苗損害法案》。法案規(guī)定，疫苗受害者在受害6個(gè)月后（或受害者死亡2年內(nèi)），根據(jù)傷害程度的不同，疫苗受害者最高可以獲得25萬(wàn)美元的賠償。早在1977年，日本就制定了預(yù)防接種健康被害救濟(jì)制度。接種疫苗者若出現(xiàn)后遺癥導(dǎo)致住院，可申請(qǐng)醫(yī)療費(fèi)外加一定補(bǔ)助；如果出現(xiàn)身體殘障甚是死亡等嚴(yán)重情況，可申請(qǐng)獲得遺屬年金或一次性補(bǔ)償及喪葬費(fèi)等。2005年，中國(guó)政府也發(fā)布了《疫苗流通和預(yù)防接種管理?xiàng)l例》，條例規(guī)定：“對(duì)因異常反應(yīng)引起的嚴(yán)重?fù)p害者給予一次性補(bǔ)償，具體補(bǔ)償辦法由省、自治區(qū)、直轄市人民政府制定，屬于一類(lèi)疫苗引起的預(yù)防接種異常反應(yīng)的補(bǔ)償費(fèi)用由省級(jí)財(cái)政安排，屬于二類(lèi)疫苗引起的預(yù)防接種異常反應(yīng)的補(bǔ)償費(fèi)用由生產(chǎn)企業(yè)承擔(dān)。”

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.

除了賠償外，各國(guó)也在為減少疫苗不良反應(yīng)竭盡全力。英國(guó)政府要求疫苗在上市前必須進(jìn)行質(zhì)量和有效性檢測(cè)。檢測(cè)分兩個(gè)層次，第一個(gè)層次為生產(chǎn)商自測(cè)，第二層次則由歐盟認(rèn)可的幾家官方藥品檢測(cè)實(shí)驗(yàn)室其中的一家再次檢測(cè)，只有通過(guò)檢測(cè)才能獲批入市。

為保證疫苗的安全，德國(guó)的疫苗專(zhuān)用運(yùn)輸車(chē)除駕駛室外，全部采用避光、密封性能好的特殊材料制成，且每輛車(chē)都有防熱、防靜電、防輻射等功能。同時(shí)，每車(chē)還配有安保人員，運(yùn)輸車(chē)將疫苗運(yùn)到各州的疫苗公司后，會(huì)被放入專(zhuān)門(mén)的疫苗倉(cāng)庫(kù)。而存放疫苗的變溫儲(chǔ)藏柜可根據(jù)每種疫苗的不同需要進(jìn)行溫度調(diào)節(jié)。

日本不斷完善不良反應(yīng)監(jiān)測(cè)機(jī)構(gòu)，增加第三方醫(yī)師和專(zhuān)家。在實(shí)際操作過(guò)程中，生產(chǎn)企業(yè)應(yīng)報(bào)告所生產(chǎn)的疫苗發(fā)生的所有不良反應(yīng)，而不采用所謂的“安全比率”。

新中國(guó)成立以來(lái)，中國(guó)政府堅(jiān)持“預(yù)防為主，防治結(jié)合”方針，不斷加大傳染病防治力度，2002年，中國(guó)將新生兒Hepatitis B疫苗納入國(guó)家免疫規(guī)劃，國(guó)家免疫規(guī)劃由接種4種疫苗預(yù)防6種傳染病，擴(kuò)大到接種5種疫苗預(yù)防7種傳染病。2009年起，中國(guó)各級(jí)疾控部門(mén)開(kāi)始對(duì)15歲以下未接種過(guò)Hepatitis B免疫的人群，免費(fèi)補(bǔ)種Hepatitis B疫苗。據(jù)《中國(guó)經(jīng)營(yíng)報(bào)》報(bào)道，按照2007年原衛(wèi)生部發(fā)布的擴(kuò)大國(guó)家免疫規(guī)劃實(shí)施方案，Hepatitis B疫苗明確規(guī)定應(yīng)接種3劑次，分別是在兒童出生時(shí)、1月齡、6月齡，其中第1劑應(yīng)在“出生后24小時(shí)內(nèi)盡早接種”。