PDF《中国流感疫苗预防接种技术指南》

1 中国流感疫苗预防接种技术指南 (2018-2019) (完整版) 中国疾病预防控制中心 国家免疫规划技术工作组流感疫苗工作组

2 目录摘要1Abstract

4 正文

6

一、病原学基础、临床特点和实验室诊断

6

(一)病原学基础.

6

(二)临床特点和实验室诊断

8

二、流行病学

10

(一)传染源、传播途径及潜伏期

10

(二)流感在我国的流行特点和季节性

11

(三)疾病负担.12 1.健康负担.12 2.经济负担和健康效用.27

(四)流感的预防治疗措施

28

三、流感疫苗

29

(一)国内外供应的流感疫苗

29

(二)IIV3 和IIV4 接种后的免疫反应、免疫持久性

31

(三)IIV3 和IIV4 的免疫原性、效力和效果

33 1.全人群.35 2.孕妇.37 3.儿童.38 4.学生.44 5.老年人.46 6.慢性基础性疾病患者.49

3 7.医务人员.50

(四)IIV3 和IIV4 的安全性

51 1.安全性.52 2.罕见不良反应.57

(五)疫苗成本效果、成本效益

60

四、2018-2019 年度接种建议.63

(一)抗原组份.64

(二)疫苗种类及适用年龄组

64

(三)建议优先接种人群.65 1.6-23 月龄的婴幼儿.65 2.2-5 岁儿童.66 3.60 岁及以上老年人.66 4.特定慢性病患者.66 5.医务人员.66 6.6 月龄以下婴儿的家庭成员和看护人员

66 7.孕妇或准备在流感季节怀孕的女性

67

(四) 接种剂次.67 1.6 月龄-8 岁儿童.67 2.9 岁及以上儿童和成人.67

(五)接种时机.68

(六)接种部位及方法.68

(七)疫苗储存.68

(八)禁忌证.69

(九)药物相互作用.69

4

(十)接种注意事项.70 表1. 国内批签发的流感疫苗类型、规格(截至

2018 年9月)71 表2. 我国华南地区 2010-2012 年度流感疫苗的保护效果

72 表3. 不同人群流感疫苗效力、效果研究比较

73 参考文献

89 附录

113 1 摘要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 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.目前,我国国内批准上市的流感 疫苗为三价灭活流感疫苗(IIV3)和四价灭活流感疫苗(IIV4),包括 裂解疫苗和亚单位疫苗.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. 为指导我国流感预防控制和疫苗应用工作, 中国疾控中心国家免 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, 对2014 年版指南进行了更新和修订,形成了《中国流感疫苗预防接种技术指 南(2018-2019)》.本指南主要更新了以下内容:流感的流行病学、 疾病负担,流感疫苗的种类、2018-2019 年度流感疫苗抗原组份、三 价灭活疫苗(IIV3)和四价灭活疫苗(IIV4)的免疫反应、免疫持久 性、免疫原性、效力、效果、安全性、成本效果和成本效益等新的科 学证据,并基于现有的科学证据,提出了 2018-2019 年度流感疫苗预 防接种的建议.

2 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-5 岁儿童、60 岁及以上老年人、慢性病患者、医务人 员、6 月龄以下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-8 岁儿 童应接种两剂次,间隔≥4 周;

2017-2018 年度或以前接种过一剂或 以上流感疫苗的儿童,建议接种一剂.9 岁及以上儿童和成人仅需接 种1剂.建议各地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疾病预防控制机构工作 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. 本指南正式版已由中国疾病预防控制中心下发文件 (中疾控传防 发[2018]

91 号)至各省、自治区、直辖市疾病预防控制中心,新疆 生产建设兵团疾病预防控制中心.

3 Technical Guidelines for Seasonal Influenza Vaccination in China (2018-2019) (Full Edition) Chinese Center for Disease Control and Prevention National Immunization Advisory Committee (NIAC) Technical Working Group (TWG), Influenza Vaccination TWG

4 Abstract Influenza virus infection is a respiratory infectious disease that can seriously affect human health. Influenza viruses can have frequent antigenic variation and changes, which can result in rapid and widespread transmission resulting in annual epidemics and outbreaks in places of public gathering such as schools, kindergartens and nursing homes. The World Health Organization (WHO) estimated that seasonal influenza epidemics have caused an annual

3 to

5 million severe cases, and

290000 to

650000 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) and quadrivalent inactivated influenza vaccine (IIV4), including split-virus influenza vaccine and subunit vaccine. Except for a few major cities, influenza vaccine is a category Ⅱ vaccine, which means influenza vaccination is voluntary, and recipients must pay for it. To strengthen the technical guidance for prevention and control of influenza and operational research on influenza vaccination in China, the National Immunization Advisory Committee (NIAC) Influenza Vaccine Technical Working Group (TWG), updated the

2014 technical guidelines and compiled the Technical guidelines for seasonal influenza vaccination in China (2018-2019) . The main updates in this version include: epidemiology, disease burden, types of influenza vaccines, northern hemisphere influenza vaccination composition for the 2018-2019 season, IIV3 and IIV4 immune response, durability of immunity, immunogenicity, vaccine efficacy, effectiveness, safety, cost-effectiveness and cost-benefit. The influenza vaccine TWG provided the recommendations for influenza vaccination for the 2018-2019 influenza season based on existing scientific evidence. The recommendations described in this report include the following: 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 for whom more than one licensed, recommended, and appropriate product is available. 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 6-59 months, adults ≥60 years of age, persons with specific chronic diseases, healthcare workers, the family members and caregivers of infants /=18 years[J]. BMC Infect Dis, 2013, 13: 343. [205] Langley JM, Carmona MA, Chatterjee A, et al. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children[J]. J Infect Dis, 2013, 208(4): 544-553. [206] 胡昱, 李倩, 陈雅萍, 等.

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101 [221] Zhang Y, Wu P, Feng L, et al. Influenza vaccine effectiveness against influenza-associated hospitalization in 2015/16 season, Beijing, China[J]. Vaccine, 2017, 35(23): 3129-3134. [222] Moa AM, Chughtai AA, Muscatello DJ, et al. Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials[J]. Vaccine, 2016, 34(35): 4092-4102. [223] Bekkat-Berkani R, Ray R, Jain VK, et al. Evidence update: GlaxoSmithKline'

s inactivated quadrivalent influenza vaccines[J]. Expert Rev Vaccines, 2016, 15(2): 201-214. [224] Crepey P, de Boer PT, Postma MJ, et al. Retrospective public health impact of a quadrivalent influenza vaccine in the United States[J]. Influenza Other Respir Viruses, 2015,

9 Suppl 1: 39-46. [225] Kittikraisak W, Chittaganpitch M, Gregory CJ, et al. Assessment of potential public health impact of a quadrivalent inactivated influenza vaccine in Thailand[J]. Influenza Other Respir Viruses, 2016, 10(3): 2........