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1 Hib 疫苗未充分使用的好疫苗许锐恒 GDCDC

2 内容 1. Hib 疾病要及早预防 2. Hib 疫苗 PRP-T PRP-OMP 联合疫苗 3. Hib 疫苗 - 未充分使用的好疫苗 2

3 1. Hib 疾病要及早预防 3

B 型流感嗜血杆菌 (Hib) Haemophilus influenzae Type b 流感嗜血杆菌是细菌感染原因之一, 通常严重, 尤其在婴幼儿 1892 年,Pfeiffer 首次在流感爆发的病人的痰中发现并认为这种细菌是流感的病因 1920 年,Winslow 等命名为嗜血杆菌 1933 年,Smith

4 B 型流感嗜血杆菌 (Hib) Haemophilus influenzae Type b 流感嗜血杆菌是细菌感染原因之一, 通常严重, 尤其在婴幼儿 1892 年,Pfeiffer 首次在流感爆发的病人的痰中发现并认为这种细菌是流感的病因 1920 年,Winslow 等命名为嗜血杆菌 1933 年,Smith 等确定流感是病毒引起的流感嗜血杆菌是继发感染的原因 1930s, Margaret Pittman 确定 a b c d e f, 6 个血清型革兰阴性需氧菌球杆菌几乎所有从脑脊液和血液分离到的都是 b 型在疫苗前期, 95 % 儿童侵袭性疾病是由 Hib 引起的 USCDC, Pink Book 12th Edition,

5 B 型流感嗜血杆菌 (Hib) Haemophilus influenzae type b (Hib) 流感嗜血杆菌有 6 种血清型 ( a / b / c / d / e / f ) b 型流感嗜血杆菌是其一 Hib 通常附着在人的鼻咽部 Hib 通过飞沫人传人, 喷嚏 / 咳嗽感染的儿童可携带 Hib 无任何病征, 但可传给他人 6 月龄 ~ 2 岁为高危儿童 Hib 结合疫苗安全有效, 应纳入儿童常规免疫规划 hib WHO position paper

6 WHO 有关 HIb 接种的说明应尽早在 6 周龄开始接种第一针 3 针基础免疫与 DTP 基础 3 针同时接种, 通常使用联合疫苗延迟接种, 如 12~24 月龄内无接种基础免疫, 接种 1 针即可加强针次, 可在 12~18 月龄之间但 WHO 目前尚未做推荐 > 24 月龄的儿童一般不接种因该年龄段的儿童的 Hib 疾病负担有限 6

7 美国使用疫苗前 Hib 临床表现 Haemophilus influenzae type b Clinical Features, prevaccination era 会厌炎肺炎 Epiglottitis 17% Pneumonia 15% 脑膜炎 Meningitis 50% 骨髓炎 Osteomyelitis 2% Arthritis 8% Cellulitis Bacteremia 6% 2% 关节炎蜂窝织炎菌血症 USCDC, Pink Book 12th Edition,

8 <5 岁儿童 Hib 疾病发病率,1/100,000,2000 Hib incidence rate per 100,000 children under five years of age, 2000 Date of slide: 3 August 2009 < < <2000 >

9 <5 岁儿童 Hib 疾病估计死亡率,1/100,000 Children younger than 5 years.hib estimated mortality rate (1/100,000) Burden of disease caused by Haemophilus influenzae type b in children younger than 5 years global estimates, The Lancet, 374, 9693,September ,

10 疫苗前期 46 国 <5 岁儿童 Hib 脑膜炎发病率,1/100,000 Country-specific incidence,* by quartile, of Hib meningitis per children < 5 years of age for 46 countries in the pre-vaccine era 10

11 美国 Hib 月龄别发病率 (1/10 万 ), 使用疫苗前,1986 Haemophilus influenzae type b, 1986 Incidence(prevaccine era) by Age Group 病月龄发Incidence 率1/10 万需早接种疫苗, 早预防! Age group (mos) USCDC, Pink Book 12th Edition,

5 岁儿童常规疫苗可预防的疾病估计死亡分布, 2008 Distribution of the estimated deaths among children under 5 years of age, from diseases that are preventable by vaccination in 2008

12 5 岁儿童常规疫苗可预防的疾病估计死亡分布, 2008 Distribution of the estimated deaths among children under 5 years of age, from diseases that are preventable by vaccination in WHO 估计 2008 年 5 岁儿童死于常规疫苗可预防的疾病有 150 万占全球 5 岁儿童总死亡数的 17% 12

13 <5 岁儿童死亡率 (1/1000 活产 ),

14 肺炎的主要事实 Pneumonia Key facts 肺炎是全球儿童的头号死因肺炎估计每年导致 <5 岁儿童死亡 120 万 >AIDS+ 疟疾 + 结核肺炎可由病毒细菌或真菌引起肺炎可经免疫适当的营养和好的环境预防肺炎可用抗生素治疗但只有约 30% 的儿童得到合适的抗生素

15 肺炎的主要事实 Pneumonia Key facts 肺炎球菌和 Hib 是儿童肺炎的头 2 位细菌病因预防儿童肺炎是减少儿童死亡率策略的重要组成部分接种 Hib 疫苗麻疹疫苗肺炎球菌疫苗百日咳疫苗是预防肺炎的最有效的办法

16 2. Hib 疫苗 PRP-T PRP-OMP 联合疫苗 16

17 Hib 疫苗 Hib 荚膜多糖疫苗 (HbPV) 1985, 在美国上市 ;1988, 不再用目前得到许可的结合疫苗有 - 白喉类毒素 (PRP-D) 18 月龄以下儿童效果差, 很多国家已不用 - 变异白喉类毒素 - 破伤风类毒素 (PRP-HbOC) (PRP-T) - 脑膜炎球菌外膜蛋白 (PRP-OMP) 目前的使用有 PRP-T PRP-OMP PRP-HbOC - 抗原性好 - 启动 T 细胞依赖性免疫 - 可诱发加强注射反应 ( IgG 抗体 ) - 易于结合到国家免疫规划 17

18 Hib vaccine Hib 多糖疫苗,(HbPV) 1985~1988, <18 月龄无效 Hib 结合疫苗第一个结合疫苗为 (PRP-D, ProHIBIT), 美国现已不用 HibTITER (HbOC) 也不用 USCDC, Pink Book 12th Edition,

19 FDA 许可的 Hib 疫苗 Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents DTaP/IPV/Hib (PRP-T) 破伤风类毒素 Sanofi Pasteur, Ltd (Pentacel) Hib (PRP-T) 破伤风类毒素 Sanofi Pasteur, SA (ActHIB); GlaxoSmithKline Biologicals, S.A., (Hiberix) Hib (PRP-OMP) 脑膜炎球菌外膜蛋白 Merck Sharp & Dohme Corp. (PedvaxHIB) Hib (PRP-OMP) / HepB 脑膜炎球菌外膜蛋白 Merck & Co, Inc (Comvax) 19

20 3 种 Hib 结合疫苗的特点 Characteristics of Different Hib Conjugate Vaccines 婴幼儿接种 3 针基础免疫后与 PRP-OMP 和 PRP-CRM ( 变异白喉类毒素 ) 比 PRP-T 的抗体平均水平最高加强接种后至 2.5 岁时 PRP-T 的抗体水平维持最高 Dose response of CRM197 and tetanus toxoid-conjugated Haemophilus influenzae type b vaccines, Vaccine, 23, 6, r 2004,

21 ACIP 推荐 Hib 疫苗常规接种程序 ACIP-Recommended Haemophilus influenzae type b (Hib) Routine Vaccine Schedule 月月月月 PRP-T (Hiberix) 疫苗只许可用于 12 月龄的最后 1 针 USCDC, Pink Book 12th Edition,

22 Hib 接种年龄和针次间隔 Recommended and minimum ages and intervals between vaccine doses 针次推荐接种月龄接种最小龄推荐与下一针间隔最小间隔联合疫苗接种的最小年龄是其单苗成份中接种的最大年龄最小针次间隔是其单苗成份中接种的最大间隔 MMWR / January 28, 2011 / Vol. 60 / No. 2 22

23 Hib 疫苗详细接种程序 Detailed Vaccination Schedule for Haemophilus influenzae type b Conjugate Vaccines 疫苗首剂接种月龄基础程序加强 Sanofi Pasteur Merck PRP-T (Hiberix) 疫苗只许可用于 12 月龄的最后 1 针加强针与前 1 针至少隔 2 个月 USCDC, Pink Book 12th Edition,

24 0~6 岁儿童推荐免程序, 美国, 2012 Recommended Immunization Schedule for Persons Aged 0 6 Years UNITED STATES 2012 HIb 接种最小年龄 6 周如在 2 4 月龄接种 PRP-OMP (PedvaxHIB or Comvax [HepB-Hib]),6 月龄时不接种第 3 针 Hiberix 只用于接种加强针次,12 月龄 ~ 4 岁时的最后 1 针 24

25 Last update: 4-Oct-2012 (data as of 2-Oct-2012). Hib 疫苗接种程序摘抄 Hib vaccine schedule selection form 美国意大利希腊澳大利亚日本新西兰 25

26 引入 Hib 疫苗的国家,1997~

27 引入 Hib 疫苗的国家及覆盖率,

28 英国使用 Hib 结合疫苗的年序史,1992~2010 Chronological history of Haemophilus influenzae serotype b (Hib) conjugate vaccines used in the United Kingdom ( ). Dose response of CRM197 and tetanus toxoid-conjugated Haemophilus influenzae type b vaccines, Vaccine, 23, 6, r 2004,

29 29

30 30

31 FDA 许可的联合疫苗 FDA-licensed combination vaccines MMWR / January 28, 2011 / Vol. 60 / No. 2 31

32 Last update: 4-Oct-2012 (data as of 2-Oct-2012). Hib 单苗和联合疫苗 Hib vaccine and combination vaccine 32

33 Last update: 4-Oct-2012 (data as of 2-Oct-2012). DTaPHibIPV 疫苗接种程序摘抄 'DTaPHibIPV vaccine schedule selection form 南非加拿大丹麦德国冰岛西班牙瑞典瑞士土耳其英国马来西亚 33

34 DTaP IPV / Hib 5 联疫苗 DTaP-IPV/Hib Vaccine 34

35 美国时代周刊 :2008 年 10 大医学突破 Top 10 Medical Breakthroughs of TIME 将患者皮肤细胞转变成运动神经元发炎容易导致心脏病发作无疤痕手术基因图谱大众化新发现 4 种早老性痴呆基因五合一疫苗 Pentacel 基因扫描查找乳腺癌验血预知唐氏综合症晕船贴用于治疗化疗呕吐首次干细胞器官移植 35

36 5 合 1 疫苗, 时代周刊 :2008 年 10 大医学突破 A Five-in-One Vaccine - Top 10 Medical Breakthroughs of TIME 36

37 中国的临床试验 DTaP-IPV//PRP-T ( Pentaxim 潘太欣 ) A 组月龄 B 组月龄 DTaP ( 武汉所 ), IPV ( Imovax Polio), PRP-T ( Act-Hib ) C 组月龄潘太欣的月龄月龄接种程序血清抗体水平和血清阳转率不低于单苗安全性好 Immunogenicity and safety of a pentavalent DTaP-IPV-Hib for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China, 37 Vaccine, Vol 29,10, 4 Feb 2011,Pages

38 中国的临床试验 ( Pentaxim 潘太欣 ) 法国单苗法国单苗 Immunogenicity and safety of a pentavalent DTaP-IPV-Hib for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China, 38 Vaccine, Vol 29,10, 4 Feb 2011,Pages

39 中国的临床试验 39

40 提高覆盖率的策略 Strategies to Improve Immunization Rates 接种疫苗的文字说明 Standing orders 计算机预约备忘 Computerized record reminders 给受种者疫苗接种说明表格 Chart reminders 总结评估改进 Performance feedback 家访 Home visits 邮件 / 电话提醒 Mailed/Telephoned reminders 外展服务 Expanding access in health care settings 健康教育 Patient education 个人健康记录 Personal health records 联合疫苗 Combination vaccine CDC. Accessed January

41 3. Hib 疫苗 - 未充分使用的好疫苗 41

万近年实施接种新的和未充分使用的疫苗大大增加预防了更多的过早死亡和伤残乙型肝炎疫苗 Hib

42 未充分使用的疫苗 Under-utilized Vaccines 1974 年启动的 EPI, 使用疫苗预防白喉破伤风百日咳脊髓灰质炎麻疹肺结核 (BCG) 每年预防死亡人数近 250 万近年实施接种新的和未充分使用的疫苗大大增加预防了更多的过早死亡和伤残乙型肝炎疫苗 Hib 疫苗肺炎球菌疫苗轮状病毒疫苗风疹疫苗

43 43

44 引入 Hib 疫苗的国家,1997~

45 Hib 疫苗引入国家免疫规划的国家,2010 和计划引入的国家,2011 Countries Using Hib Vaccine in National Immunization Schedule as at 2010, and Planned Introductions for 2011 * The Philippines will introduce nationwide in India is planning to introduce Hib in 2 States in The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO All rights reserved Yes (166 countries or 86%) Yes part of the country (3 countries or 2%) Introduction in 2011* (7 countries or 4%) No (18 countries or 9%) Source: WHO/IVB database. Data as of September The data for 2011 is provisional. 193 WHO Member States. Date of slide: 26 September

46 引入含 Hib 疫苗的国家, Number of Countries Having Introduced Hib (containing) Vaccines to Date Data Source: Joint Reporting Form, 2011 and NUVI database Map production: Immunization Vaccines and Biologicals, (IVB), World Health Organization Date of slide: 11 September 2012 Introduced* (179 countries or 92%) Planned introduction in 2012 (6 countries or 3%) Planned introduction in 2013 (4 countries or 2%) ,700 3,400 Kilometers * Includes partial introductions Not Introduced (5 countries or 3%) Not available Not applicable The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO All rights reserved 46

47 引入 Hib 疫苗的国家和婴幼儿 Hib 覆盖率,2010 Countries Having Introduced Hib Vaccine and Infant Hib Coverage, 2010 The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. WHO All rights reserved (169 countries introduced in infant immunization schedule) Hib3 > 80% (134 countries or 69%) Hib3 < 80% (30 countries or 16%) Hib vaccine introduced but no coverage data reported (5 countries or 2%) Hib vaccine not introduced (24 countries or 13%) Source: WHO/UNICEF coverage estimates , Source: September WHO/IVB database, September WHO Member States. Date of slide: 22 September Date of slide: 22 September

48 Hib 3 针覆盖率 (%),WHO UNICEF 估计全球美洲区欧洲区东地中海非洲区东南亚西太区 WHO Vaccine Preventable Diseases Monitoring System 2012 Global summary Last update: 4-Oct-2012 (data as of 2-Oct-2012). 48

49 全球和各区 Hib3 覆盖率,1990~ Global and Regional Hib3 Coverage, % coverage Source: WHO/UNICEF coverage estimates , July WHO Member States. Date of slide: 23 September countries introduced Hib vaccine African 非洲 American 美洲 Eastern Mediterranean 东地中海 European 欧洲 South East Asian Western Pacific 西太区 Global 全球东南亚 49

50 全球婴幼儿 Hib 3 针覆盖率,1990~2010 美洲欧洲非洲东地中海东南亚西太区全球东地中海西太区非洲欧洲美洲东南亚 50

51 Hib 3 针覆盖率 (%),WHO UNICEF 估计澳大利亚加拿大美国法国英国赞比亚肯尼亚马来西亚孟加拉越南老挝 Immunization surveillance, assessment and monitoring,

52 引入 Hib 疫苗的国家数和 DTP3 Hib3 覆盖率,1990~2010 Number of Countries Having Introduced Hib Vaccine and Global Infant DTP3 and Hib3 Coverage, number of countries * % coverage Number of countries introduced Hib Hib3 coverage DTP3 Coverage * For all years, country totals include partial and full introductions, and for 2010, figure includes the three countries that had introduced in parts of the country. Source: WHI/IVB Database & WHO/UNICEF coverage estimates , July WHO Member States. Date of slide: 21 September

53 <5 岁儿童 Hib 疾病死亡最多的 10 个国家 Ten countries with the greatest number of Hib deaths 印度泡泡的大小示 Hib 死亡数 10 国占全球 61% 中国 <5 岁儿童数 ( 百万 ) 巴基斯坦孟加拉尼日利亚埃塞俄比亚刚果安哥拉 8000 尼日尔阿富汗 <5 岁儿童 Hib 疾病死亡率 Burden of disease caused by Haemophilus influenzae type b in children younger than 5 years global estimates, The Lancet, 374, 9693,September ,

Hib 疫苗 Hib vaccines 预防 Hib 严重疾病, 疫苗是唯一的公共卫生手段至 2011.

54 Hib 疫苗 Hib vaccines 预防 Hib 严重疾病, 疫苗是唯一的公共卫生手段至 , 89%(171/193) 的成员国已将 Hib 疫苗纳入常规免疫规划许多工业化的国家实际上已消除侵袭性 Hib 疾病发病率在许多发展中国家已大大减少但低收入国家的许多儿童接种 Hib 疫苗仍受到限制生活在 Hib 疫苗纳入免疫规划的国家的儿童只占 52%

55 使用疫苗估计可避免的死亡人数,2011~2020 Total future deaths averted, , assuming no vaccination as the counterfactual 百万新的或未充分使用的疫苗 Global Vaccine Action Plan,

56 中华流行病学杂志 2005 年 12 月 56

57 温家宝提出今年卫生事业改革发展重点抓好四件事今年扩大国家免疫规划范围将甲肝流脑等 15 种可以通过接种疫苗有效预防的传染病纳入国家免疫规划十届全国人大五次会议上作政府工作报告儿童免疫规划甲肝流脑乙脑风疹腮腺炎高危人群出血热炭疽钩体 57

58 第二类疫苗乙型肝炎甲肝流脑乙脑风疹腮腺炎流感疫苗? Hib 疫苗? 肺炎球菌疫苗? 轮状病毒疫苗? 白喉破伤风百日咳脊髓灰质炎麻疹卡介苗第一类疫苗 58

59 如果你不接种你需要的疫苗那你可能会得到你不想要的东西如严重的感染或长期的健康问题要确定你需要的! 59

60 中共中央总书记军委主席习近平讲话我们的人民热爱生活, 期盼有更好的教育更稳定的工作更满意的收入更可靠的社会保障更高水平的医疗卫生服务更舒适的居住条件更优美的环境, 期盼着孩子们能成长得更好工作得更好生活得更好人民对美好生活的向往, 就是我们的奋斗目标 60

61 谢谢 Thanks 61

PowerPoint Presentation

PowerPoint Presentation 疫苗安全的法规保障许锐恒广东省疾病预防控制中心 xuruiheng@cdcp.org.cn 2016.03 1 内容 1. 疫苗接种和疾病防控 2. 疫苗管理相关法规 3. 疫苗研发和制造相关法规 4. 疫苗储运和流通相关法规 5. 疫苗使用和监测相关法规 6. 结