文章摘要
国家免疫规划技术工作组流感疫苗工作组.中国流感疫苗预防接种技术指南(2019-2020)[J].中华流行病学杂志,2019,40(11):1333-1349
中国流感疫苗预防接种技术指南(2019-2020)
Technical guidelines for seasonal influenza vaccination in China, 2019-2020
收稿日期:2019-10-22  出版日期:2019-11-26
DOI:10.3760/cma.j.issn.0254-6450.2019.11.002
中文关键词: 流感;疾病负担;疫苗;预防接种;技术指南
英文关键词: Influenza;Disease burden;Vaccine;Vaccination;Technical guideline
基金项目:国家科技重大专项(2018ZX10713001-005);国家自然科学基金(91846302);中美新发和再发传染病项目;中国疾病预防控制中心应急反应机制运行项目(131031001000015001);支持新疫苗纳入国家免疫规划的机制以及国家免疫规划专家委员会技术工作组能力建设(OPP1193638)
作者单位E-mail
国家免疫规划技术工作组流感疫苗工作组  fenglz@chinacdc.cn;pengzb@chinacdc.cn;dayanwang@cnic.org.cn 
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中文摘要:
      流行性感冒(流感)是由流感病毒引起的一种急性呼吸道传染病,严重危害人群健康。流感病毒其抗原性易变,传播迅速,每年可引起季节性流行,在学校、托幼机构和养老院等人群聚集的场所可发生暴发疫情。每年流感季节性流行在全球可导致300万~500万重症病例,29万~65万呼吸道疾病相关死亡。孕妇、婴幼儿、老年人和慢性基础疾病患者等高危人群,患流感后出现严重疾病和死亡的风险较高。接种流感疫苗是预防流感病毒感染及其严重并发症的最有效手段。我国现已批准上市的流感疫苗有三价灭活流感疫苗(IIV3)和四价灭活流感疫苗(IIV4),IIV3包括裂解疫苗和亚单位疫苗,IIV4为裂解疫苗。除个别地区外,流感疫苗在我国大多数地区属于第二类疫苗,实行自愿、自费接种。2018年,中国疾病预防控制中心印发了《中国流感疫苗预防接种技术指南(2018-2019)》(2018年版指南)。一年来,新的研究证据在国内外发表,新的疫苗产品在我国上市。为更好的指导我国流感预防控制和疫苗应用工作,国家免疫规划技术工作组流感疫苗工作组综合国内外最新研究进展,在2018年版指南的基础上进行了更新和修订,形成了《中国流感疫苗预防接种技术指南(2019-2020)》。本指南更新的内容主要包括以下几个方面:第一,增加了新的研究证据,尤其是我国的研究结果,包括流感疾病负担、疫苗效果、接种疫苗可避免的疾病负担、疫苗安全性监测、疫苗预防接种成本效果等;第二,增加了一年来国家卫生健康委员会流感防控有关政策和措施;第三,更新了我国2019-2020年度国内批准上市及批签发的流感疫苗种类;第四,更新了本年度IIV3和IIV4疫苗组份。本指南建议:原则上,接种服务单位应为≥ 6月龄所有愿意接种流感疫苗且无禁忌证的人提供接种服务。对可接种不同类型、厂家疫苗产品的人群,可由受种者自愿选择接种任一种流感疫苗,无优先推荐。为降低高危人群罹患流感及感染后发生严重临床结局的风险,指南推荐6月龄至59月龄儿童、≥ 60岁老年人、慢性病患者、医务人员、<6月龄婴儿的家庭成员和看护人员以及孕妇或准备在流感季节怀孕的女性为优先接种对象。首次接种流感疫苗的6月龄至8岁儿童应接种2剂次,间隔≥ 4周;2018-2019年度或以前接种过≥ 1剂次流感疫苗的儿童,建议接种1剂次。≥ 9岁儿童和成年人仅需接种1剂次。建议各地疾控机构在疫苗供应到位后尽快安排接种工作,最好在10月底前完成免疫接种;对10月底前未接种的对象,整个流行季节都可以提供接种服务。孕妇在孕期的任一阶段均可接种流感疫苗。本指南适用于从事流感防控相关的各级CDC工作人员,预防接种点的接种人员,各级医疗机构儿科、内科、感染科等医务人员,以及各级妇幼保健机构的专业人员。根据国内外研究进展,本指南今后亦将定期更新、完善。
英文摘要:
      Influenza virus infection is a respiratory infectious disease that can seriously affect human health. Influenza viruses can have antigenic variation and changes frequently, which results in rapid and widespread transmission resulting in annual epidemics and outbreaks in population gathering places such as schools, kindergartens and nursing homes. WHO estimated that seasonal influenza epidemics could cause 3 to 5 million severe cases annually, and 290 000 to 650 000 deaths globally. Pregnant women, young children, the elderly, and persons with chronic illnesses are at high risk for severe illness and death associated with influenza virus infection. Seasonal influenza vaccination is the most effective way to prevent influenza virus infection and complications from infection. Currently, China has licensed trivalent inactivated influenza vaccine (IIV3) which includes split-virus influenza vaccine and subunit vaccine, and quadrivalent inactivated influenza vaccine (IIV4) which is split. Except a few major cities, influenza vaccine is a category Ⅱ vaccine, which means influenza vaccination is voluntary, and recipients should pay for it. In 2018, China CDC issued the "Technical Guidelines for Seasonal Influenza Vaccination in China (2018-2019)" (Guide 2018). In the past year, new research evidences have been published both in China and abroad, and new seasonal influenza vaccine has been licensed in China. To strengthen the technical guidance for prevention and control of influenza and operational research on influenza vaccination in China, the Influenza Vaccination Technical Working Group (TWG) of National Immunization Advisory Committee (NIAC) updated the Guide 2018 and compiled the "Technical Guidelines for Seasonal Influenza Vaccination in China (2019-2020)". Major updates include the following:First, new research evidences especially studies of China, including disease burden, effectiveness, vaccine-avoidable disease burden, vaccine safety monitoring, and cost-effectiveness and cost-benefit. Second, policies and measures for influenza prevention and control issued by National Health Commission (PRC) in the past year. Thirdly, new type seasonal influenza vaccine licensed and issued in 2019-2020 in China. Fourth, northern hemisphere influenza vaccination composition for the 2019-2020 season was updated for both IIV3 and IIV4. The recommendations include:Points of vaccination clinics (PoVs) should provide influenza vaccination to all persons aged 6 months and above who are willing to be vaccinated and do not have contraindications. No preferential recommendation is made for one influenza vaccine product over another for persons whom can accept more than one licensed, recommended and appropriate products. To decrease the risk of severe infections and complications due to influenza virus infection among high risk groups, the recommendations prioritize seasonal influenza vaccination for children aged 6 to 59 months, adults ≥ 60 years of age, persons with specific chronic diseases, healthcare workers, the family members and caregivers of infants <6 months of age, and pregnant women or women who plan to become pregnant during the influenza season. Children aged 6 months through 8 years require 2 doses of influenza vaccine administered a minimum of 4 weeks apart during their first season of vaccination for optimal protection. If they were vaccinated in 2018-2019 influenza season or prior, 1 dose is recommended. People ≥ 9 years old require 1 dose of influenza vaccine. It is recommended that people receive their influenza vaccination by the end of October. Influenza vaccination should be offered as soon as available. For the people unable to be vaccinated before the end of October, influenza vaccination will continue to be offered for the whole season. Influenza vaccine is also recommended for use in pregnant women during any trimester. These guidelines are intended for use by staff members of the CDCs at all levels who work on influenza control and prevention, PoVs staff members, healthcare workers from the departments of pediatrics, internal medicine, and infectious diseases, and staff members of maternity and child care institutions at all levels. These guidelines will be updated periodically as new evidence becomes available.
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