中国脊髓灰质炎疫苗使用历史回顾及免疫策略调整建议

在消灭脊髓灰质炎（脊灰）过程中,脊灰疫苗发挥了重要作用。口服脊灰减毒活疫苗（Oral Poliomyelitis Attenuated Live Vaccine,OPV）是一种安全有效的疫苗,中国于20世纪60年代推广使用OPV,常规免疫接种率逐步提高到〉90％。从1990年开始,部分省（自治区、直辖市）开展了OPV补充免疫活动（Supplementary Immunization Activity,SIA）;1993～2000年,开展消灭脊灰的国家免疫日活动,中国所在的世界卫生组织（World Health Organization,WHO）西太平洋区于2000年实现无脊灰的目标,继续在适龄儿童中加强OPV常规免疫和开展SIA。根据WHO制定的（（2013—2018年消灭脊灰终结战略计划》,2015年所有国家要引进至少1剂灭活脊灰病毒疫苗（Inactivated Poliovirus Vaccine,IPV）,2016年中期使用二价OPV（I＋Ⅲ型）,2018年停用OPV。为确保OPV成功转换IPV,中国应建立部门间协作机制,加快国产IPV研发生产进程,组织开展OPV和IPV转换的相关研究。     

脊髓灰质炎疫苗应用现状及免疫策略进展

1988年,全球消灭脊髓灰质炎（脊灰）倡议行动启动以来,取得了重大进展。2012年,全球报告脊灰223例,较2011年减少〉60%,本土脊灰流行国家减少为尼日利亚、巴基斯坦和阿富汗,脊灰野病毒（Wild Poliovirus,WPV）病例数下降到历史最低水平。但WPV传播仍未被阻断,无脊灰国家/地区仍面临输入WPV的风险。同时,有些国家正面临使用口服脊灰减毒活疫苗（Oral Poliomyelitis Attenuated Live Vaccine,OPV）所致疫苗衍生脊灰病毒的风险。目前,不同国家/地区评估各自的脊灰发病风险,依据OPV、脊灰病毒灭活疫苗（Inactivated Poliovirus Vaccine,IPV）的风险和收益,不同国家/地区采用不同的免疫策略：仅使用IPV、序贯使用IPV/OPV和仅使用OPV。2013年,世界卫生组织《全球消灭脊灰终结战略计划》中提出,2014年全球阻断WPV传播,2015年所有国家应至少使用1剂IPV,停用OPV中的Ⅱ型组分;2018年完成消灭WPV证实后,停用OPV。现对OPV和IPV的应用现状以及免疫策略进行简述。     

脊髓灰质炎流行现状及控制对策

脊髓灰质炎（脊灰）是由脊灰病毒引起的急性肠道传染病,人是脊灰病毒的唯一宿主。1988年世界卫生组织提出2000年在全球范围内消灭脊灰,目前仅有阿富汗、印度、尼日利亚、巴基斯坦4个国家有脊灰野毒株本土病例报告。随着无脊灰目标的逐渐实现,口服脊髓灰质炎减毒活疫苗（OPV）的缺点逐渐凸现,如OPV在热带地区效力低,可引起疫苗相关麻痹脊灰（VAPP）及免疫抑制者长期排毒等,因此,继续使用OPV不能最终消灭脊灰。1996年,美国免疫实践咨询委员会推荐通过先使用脊灰灭活疫苗（IPV）再使用OPV的连续接种程序来增加IPV的使用,IPV的大量使用消除了活疫苗病毒的散播,也消除了VAPP。2008年,我国提出脊灰疫苗的免疫策略可借鉴国外成功的经验,逐步采用IPV替代OPV。目前已有学者进行了前瞻性研究,证实在中国以IPV替代OPV是可行的。     

中国在消灭脊髓灰质炎(脊灰)后期使用赛宾株-脊灰灭活疫苗替代口服脊灰减毒活疫苗策略的前瞻性分析

目的 探讨中国在消灭脊髓灰质炎(脊灰)后期的免疫策略.方法 运用循证医学的方法,检索国内外研究资料,调查中国脊灰疫苗生产和使用现状,从免疫策略比较赛宾株-脊灰灭活疫苗(Sabin-Inactivated Poliovirus Vac-cine,slPV)替代口服脊灰减毒活疫苗(Oral Poliomyelitis Live Vaccine,OPV)的可行性,并从免疫程序等方面进行前瞻性综合分析.结果 中国应考虑选择以IPV替代OPV的免疫策略,且国产sIPV即将问世,在政策、技术、疫苗供应和其它保障方面均具备了替代的条件,常规免疫可参照目前OPV免疫程序.结论 中国应进一步加强消灭脊灰后期免疫策略的研究,积极做好sIPV替代OPV的准备工作.     

首剂IPV纳入免疫规划后儿童家长的认知及态度分析

目的了解首剂脊灰活疫苗(IPV)纳入免疫规划后儿童家长的认知及态度,为制定脊灰疫苗免疫策略调整后的实施措施提供参考。方法对2016年7—12月白云街道社区卫生服务中心预防接种门诊接种脊灰疫苗儿童的家长开展问卷调查,并对在此期间参加妈妈班的家长进行个案访谈。结果本次共调查了532人,95.86%的家长知道脊灰减毒活疫苗(糖丸),76.88%认为糖丸是不安全的疫苗,21.43%的家长知道首剂IPV纳入免疫规划政策,16.73%的家长知道2价脊灰与糖丸的区别,81.39%的家长愿意按IPV+b OPV程序接种。多数家长表示赞同首针接种IPV的免疫策略。结论首剂IPV纳入免疫规划后多数家长不了解首针接种脊灰灭活疫苗的免疫策略及其意义,担心疫苗安全问题,建议进一步加强脊灰转换策略相关知识的宣传工作。     

2017-2018年江西省脊髓灰质炎疫苗疑似预防接种异常反应监测分析

目的 了解新纳入国家免疫规划的脊髓灰质炎（脊灰）疫苗的疑似预防接种异常反应（AEFI）的发生特征,评价其安全性。方法 各接种单位逐级上报2017-2018年口服二价脊灰减毒活疫苗（bOPV）和脊灰灭活疫苗（IPV）的接种剂次数,通过AEFI信息管理系统收集bOPV和IPV的AEFI个案数据,采用描述性方法统计分析AEFI报告发生率及流行病学特征。结果 2017-2018年江西脊灰疫苗AEFI报告434例,发生率为9.69/10万剂次,bOPV、IPV分别为5.85/10万剂次、21.52/10万剂次。AEFI报告例数为男童多于女童,以0岁组儿童为主,一般反应为主,主要发生在接种后48小时以内。异常反应病例的临床诊断主要为过敏性皮疹。bOPV接种后疫苗相关麻痹型脊髓灰质炎的报告发生率为0.09/10万剂次。结论 江西省脊灰疫苗安全性在可接受范围,需进一步防范严重预防接种异常反应病例的发生,并建议国家尽快制定2剂IPV加2剂bOPV的免疫策略。     

中国脊髓灰质炎疫苗免疫策略的思考及建议

脊髓灰质炎(脊灰)曾在中国广泛流行,接种脊灰疫苗是消灭脊灰最有效的手段。脊灰有两种疫苗—口服脊灰减毒活疫苗(Oral poliomyelitis attenuated live vaccine,OPV)和脊灰灭活疫苗(Inactivated poliomyelitis vaccine,IPV)。两种疫苗的接种均可实现消灭脊灰野病毒(Wild poliovirus,WPV)的目标。目前全球WPV病例数已经达到历史最低水平,Ⅱ型疫苗衍生脊灰病毒(Type 2 vaccine-derived poliovirus,VDPV2)病例数远超过WPV病例数。为了最终实现消灭所有脊灰病例的目标,世界卫生组织提出全球最终将停止接种OPV,使用IPV的建议。本文根据全球消灭脊灰形势的变化,结合中国维持无脊灰工作进展和需要,提出中国脊灰疫苗免疫策略,即在保证国产IPV供应基础上,由目前的1剂IPV加3剂二价OPV(Bivalent oral polio vaccine,bOPV)的常规免疫程序,过渡到2剂IPV加2剂bOPV的免疫程序,直至全球消灭脊灰证实后,在常规免疫接种中停用bOPV,全程接种IPV。     

中国脊髓灰质炎疫苗的免疫策略

脊髓灰质炎（脊灰）是危害人类最严重的传染病之一.几十年来,世界各国为预防和消灭脊灰进行了艰苦的努力,并取得了巨大的成功.我国自1995年以来已经没有本土的脊灰野病毒感染病例.在目前的形势下,如何巩固成绩,评价和使用不同脊灰疫苗,是我国政府、相关部门和科学卫生工作者面临的急迫问题.为此,2006年1月13日,中国医学科学院在北京组织召开了口服脊灰减毒活疫苗（OPV）及灭活脊灰疫苗（IPV）在中国的应用策略高层专家研讨会.会议由中国工程院副院长、中国医学科学院院长刘德培院士主持,国内相关专家对我国消灭脊灰面临的问题进行了讨论,并为今后消灭脊灰的免疫策略提出了建议.     

浙江省杭州市2010～2014年出生儿童脊髓灰质炎疫苗接种分析

目的分析杭州市2010~2014年出生儿童不同类型脊髓灰质炎(脊灰)疫苗接种情况,为脊灰灭活疫苗(IPV)纳入国家免疫规划(EPI)策略改变的衔接提供依据。方法从杭州市儿童免疫规划信息管理系统中导出2010~2014年出生儿童脊灰疫苗接种数据,运用描述性流行病学方法进行分析。结果杭州市2010~2014年出生儿童566 894人,脊灰疫苗基础免疫接种率为97.52%,全程使用口服脊灰减毒活疫苗(OPV)、全程使用IPV和使用序贯程序的儿童比例分别为70.57%、27.01%和2.41%。全程使用IPV的覆盖率逐年增高,城区儿童(41.98%)高于农村儿童(18.98%),常住儿童(34.06%)高于流动儿童(17.64%)。结论杭州市脊灰疫苗接种水平较高,IPV使用比例和全程使用IPV的儿童增多,全程使用IPV儿童可能存在潜在的肠道免疫缺失的风险,建议开展相关研究,同时在IPV纳入EPI的过渡时期做好宣传沟通工作。     

我国现阶段维持无脊髓灰质炎状态面临的挑战和对策

中国通过使用口服脊髓灰质炎（脊灰）减毒活疫苗（OralPoliomyelitisAttenuatedLiveVaccine,OPV）、加强OPV常规免疫和开展补充免疫活动,以及加强急性弛缓性麻痹（AcuteFlaccidParalysis,AFP）病例监测,消灭脊灰已取得了重大进展。1994年报告最后1例本土脊灰野病毒（WildPoliovirus,WPV）病例,2000年包括中国在内的世界卫生组织西太平洋区实现无脊灰目标。随后中国实施了维持无脊灰策略和措施,但2011年新疆维吾尔自治区发生了输入脊灰疫情。在现阶段中国维持无脊灰状态面临的挑战包括：WPV输入风险很大,疫苗衍生脊灰病毒（Vaccine—derivedPoliovirus,VDPV）和疫苗相关麻痹型脊灰病例时有发生,常规免疫存在薄弱环节,脊灰疫苗免疫策略需要调整。为继续维持无脊灰状态,直至全球消灭脊灰,中国要大力加强OPV常规免疫,适时引入脊灰病毒灭活疫苗和调整脊灰疫苗免疫策略,保持高水平AFP病例监测质量,及时和有效地处置可能发生的WPV输入和VDPV循环事件,开展WPV、VDPV及其感染或潜在感染性材料的封存和安全处理。     

Introduction of inactivated polio vaccine (IPV) into the routine immunization schedule of South Africa

South Africa is currently the only country on the African continent using inactivated polio vaccine (IPV) for routine immunization in a sequential schedule in combination with oral polio vaccine (OPV). IPV is a component of an injectable pentavalent vaccine introduced nationwide in April 2009 and administered according to EPI schedule at 6, 10 and 14 weeks with a booster dose at 18 months. OPV is administered at birth and together with the first IPV dose at 6 weeks, which stimulates gut immune system producing a memory IgA response (OPV), followed by IPV to minimize the risk of vaccine associated paralytic polio (VAPP). OPV is also given to all children under 5 years of age as part of regular mass immunizations campaigns. The decision to incorporate IPV into the routine schedule was not based on cost-effectiveness, which it is not. Other factors were taken into account: Firstly, the sequence benefits from the initial mucosal contact with live(vaccine) virus which promotes the IgA response from subsequent IPV, as well as herd immunity from OPV, together with the safety of IPV. Secondly, given the widespread and increasing use of IPV in the developed world, public acceptance of vaccination in general is enhanced in South Africa which is classified as an upper middle income developing country. Thirdly, to address equity concerns because of the growing use of IPV in the private sector. Fourthly, the advent of combination vaccines facilitated the incorporation of IPV into the EPI schedule.     

Role of National Immunization Technical Advisory Group on improvement of immunization programmes in the Islamic Republic of Iran

The National Immunization Technical Advisory Group (NITAG) was established in Iran in 1982 and has made many important technical recommendations (e.g., regarding polio eradication, introduction of new vaccines, organizing special studies) that have contributed to a dramatic decline in vaccine preventable disease burden. The NITAG consists of experts from the Ministry of Health and Medical Education (MOHME), vaccine manufacturers, and medical universities with national Expanded Program of Immunization (EPI) staff serving as the secretariat. It is not completely independent from MOHME or EPI. It meets on a quarterly basis, and publishes national guidelines and immunization schedules that are updated regularly. Although primarily an advisory body, representation from MOHME members, including the EPI manager, ensures almost universal implementation of NITAG recommendations.     

Polio vaccines: WHO position paper,January 2014 – Recommendations

This article presents the World Health Organizations (WHO) evidence and recommendations for the use of polio vaccination from the WHO position paper on polio vaccines – January 2014 recently published in the Weekly Epidemiological Record [1]. This position paper summarizes the WHO position on the introduction of at least one dose of inactivated polio vaccine (IPV) into routine immunization schedules as a strategy to mitigate the potential risk of re-emergence of type 2 polio following the withdrawal of Sabin type 2 strains from oral polio vaccine (OPV). The current document replaces the position paper on the use of polio vaccines published in 2010 [2].     

浙江省1978—2007年计划免疫卫生经济学评价

目的：科学评价浙江省实施计划免疫工作三十年来取得的成绩,进一步提高资源配置及服务效率,促进免疫规划工作的可持续发展。方法：以项目分摊方法开展对省、市及8个样本县计划免疫投入成本调研,采用ARIMA模型（Autoregressive Integrated MovingAverage Model,自回归移动平均模型）拟合脊灰、麻疹等7种疫苗针对传染病理论发病水平,结合专家论证测算疾病负担和经济效益,再用成本效果分析（Cost Effectiveness Analysis,CEA）、成本效益分析（Cost Benefit Analysis,CBA）和成本效用分析（Cost Utility Analysis,CUA）等开展评价。结果：实施计划免疫工作三十年来,浙江省减少脊灰、麻疹等7种疫苗针对传染病发病5645087人、减少死亡190748人,取得的效益合计为19．14亿元,浙江省计划免疫三十年的成本效果比（CEA）为每万元：减少67人发病及减少2人死亡、成本效益比（CBA）为1：21．31、成本效用比（CUA）为1万元：70．63DALY,分病种评价中各项指标均麻疹最高。结论：自1978年实施计划免疫工作以来,浙江省有效控制了各种疫苗针对性传染病,取得了巨大的社会经济效益。为做好免疫规划工作的可持续发展,建议继续建立稳定的筹资与投入保障机制,并着重加强麻疹等成本效益显著疾病的防控工作并适时扩大免疫规划。     

Pakistan's expanded programme on immunization: An overview in the context of polio eradication and strategies for improving coverage

Since its inception in 1978, Pakistan's Expanded Programme on Immunization (EPI) has contributed significantly towards child health and survival in Pakistan. However, the WHO-estimated immunization coverage of 88% for 3 doses of Diptheria-Tetanus-Pertussis vaccine in Pakistan is likely an over-estimate. Many goals, such as polio, measles and neonatal tetanus elimination have not been met. Pakistan reported more cases of poliomyelits in 2011 than any other country globally, threatening the Global Polio Eradication Initiative. Although the number of polio cases decreased to 58 in 2012 through better organized supplementary immunization campaigns, country-wide measles outbreaks with over 15,000 cases and several hundred deaths in 2012–13 underscore sub-optimal EPI performance in delivering routine immunizations. There are striking inequities in immunization coverage between different parts of the country. Barriers to universal immunization coverage include programmatic dysfunction at lower tiers of the program, socioeconomic inequities in access to services, low population demand, poor security, and social resistance to vaccines among population sub-groups. Recent conflicts and large-scale natural disasters have severely stressed the already constrained resources of the national EPI. Immunization programs remain low priority for provincial and many district governments in the country. The recent decision to devolve the national health ministry to the provinces has had immediate adverse consequences. Mitigation strategies aimed at rapidly improving routine immunization coverage should include improving the infrastructure and management capacity for vaccine delivery at district levels and increasing the demand for vaccines at the population level. Accurate vaccine coverage estimates at district/sub-district level and local accountability of district government officials are critical to improving performance and eradicating polio in Pakistan.     

Polio immunization policy in Mexico: economic assessment of current practice and future alternatives

The World Health Organization recommends that all children aged less than 5 years should be vaccinated against polio through intensive immunization programmes as well as routine immunization. A national immunization week (NIW) was held in February 2002 in the Monterrey district of Mexico. A prospective micro-costing study was conducted to measure the total cost to the state of the NIW, the cost profile, and the ratio of cost per immunization contact to cost per dose of oral polio vaccine (OPV), and to compare OPV and inactive polio vaccine (IPV) in economic terms. Two scenarios were used as the basis for calculation. The cost of volunteers was excluded from the "lower-cost scenario" and included in the "upper-cost scenario". The total cost of the NIW was USD 100,454 for the lower-cost scenario and USD 156,614 for the upper-cost scenario. The major part of the costs was personnel costs (67.30 and 77.53% of the total costs in the lower- and upper-cost scenario, respectively). The ratio of cost per immunization contact to cost per dose of OPV was 6.45 for the lower-cost scenario and 10.05 for the upper-cost scenario. Changing from the current OPV-based intensive and routine schedule to a sequential IPV-OPV routine schedule would save USD 14.52 per vaccinated child, and changing to a full IPV routine schedule would save USD 9.41 per vaccinated child.