Ropero-Álvarez A M, Whittembury A, Bravo-Alcántara P, Kurtis H J, Danovaro-Holliday M C, Velandia-González M
Comprehensive Family Immunization Unit, Pan American Health Organization, Washington, DC, USA.
Comprehensive Family Immunization Unit, Pan American Health Organization, Washington, DC, USA.
Vaccine. 2015 Jan 1;33(1):187-92. doi: 10.1016/j.vaccine.2014.10.070. Epub 2014 Nov 6.
As part of the vaccination activities against influenza A[H1N1]pdm vaccine in 2009-2010, countries in Latin American and the Caribbean (LAC) implemented surveillance of events supposedly attributable to vaccines and immunization (ESAVI). We describe the serious ESAVI reported in LAC in order to further document the safety profile of this vaccine and highlight lessons learned. We reviewed data from serious H1N1 ESAVI cases from LAC countries reported to the Pan American Health Organization/World Health Organization. We estimated serious ESAVI rates by age and target group, as well as by clinical diagnosis, and completed descriptive analyses of final outcomes and classifications given in country. A total of 1000 serious ESAVI were reported by 18 of the 29 LAC countries that vaccinated against A[H1N1]pdm. The overall reporting rate in LAC was 6.91 serious ESAVI per million doses, with country reporting rates ranging from 0.77 to 64.68 per million doses. Rates were higher among pregnant women (16.25 per million doses) when compared to health care workers (13.54 per million doses) and individuals with chronic disease (4.03 per million doses). The top three most frequent diagnoses were febrile seizures (12.0%), Guillain-Barré Syndrome (10.5%) and acute pneumonia (8.0%). Almost half (49.1%) of the serious ESAVI were reported among children aged <18 years of age; within this group, the highest proportion of cases was reported among those aged <2 years (53.1%). Of all serious ESAVI reported, 37.8% were classified as coincidental, 35.3% as related to vaccine components, 26.4% as non-conclusive and 0.5% as a programmatic error. This regional overview of A[H1N1]pdm vaccine safety data in LAC estimated the rate of serious ESAVI at lower levels than other studies. However, the ESAVI diagnosis distribution is comparable to the published literature. Lessons learned can be applied in the response to future pandemics.
作为2009 - 2010年甲型H1N1流感大流行疫苗接种活动的一部分，拉丁美洲和加勒比地区（拉加地区）各国开展了疑似疫苗和免疫相关事件监测（ESAVI）。我们描述了拉加地区报告的严重ESAVI，以便进一步记录该疫苗的安全性概况，并突出吸取的经验教训。我们审查了拉加地区各国向泛美卫生组织/世界卫生组织报告的甲型H1N1流感严重ESAVI病例数据。我们按年龄、目标群体以及临床诊断估算了严重ESAVI发生率，并对各国给出的最终结局和分类进行了描述性分析。在29个接种甲型H1N1流感大流行疫苗的拉加国家中，有18个国家共报告了1000例严重ESAVI。拉加地区的总体报告率为每百万剂6.91例严重ESAVI，各国报告率从每百万剂0.77例至64.68例不等。与医护人员（每百万剂13.54例）和慢性病患者（每百万剂4.03例）相比，孕妇中的发生率更高（每百万剂16.25例）。最常见的三种诊断是热性惊厥（12.0%）、吉兰 - 巴雷综合征（10.5%）和急性肺炎（8.0%）。几乎一半（49.1%）的严重ESAVI报告发生在18岁以下儿童中；在这个年龄组中，2岁以下儿童报告的病例比例最高（53.1%）。在所有报告的严重ESAVI中，37.8%被归类为偶合事件，35.3%与疫苗成分有关，26.4%为无法定论，0.5%为计划错误。拉加地区甲型H1N1流感大流行疫苗安全性数据的这一区域概述估计的严重ESAVI发生率低于其他研究。然而，ESAVI诊断分布与已发表的文献相当。吸取的经验教训可应用于应对未来的大流行。
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