2007 年至 2010 年期间，8 个非洲国家黄热病预防接种运动后的不良事件。

Adverse events following yellow fever preventive vaccination campaigns in eight African countries from 2007 to 2010.

机构信息

Agence de Médecine Préventive, 164 rue de Vaugirard, 75015 Paris, France.

出版信息

Vaccine. 2013 Apr 3;31(14):1819-29. doi: 10.1016/j.vaccine.2013.01.054. Epub 2013 Feb 7.

DOI:10.1016/j.vaccine.2013.01.054

PMID:23395587

Abstract

BACKGROUND

Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown.

METHODS

From 2007 to 2010, eight African countries - Benin, Cameroon, Guinea, Liberia, Mali, Senegal, Sierra Leone, and Togo- implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and National Expert Committees to review data and classify cases. Staff in all countries received training and laboratory capacity expanded.

RESULTS

In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine doses administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for YF vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YEL-AND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variable levels of staff training and experience.

CONCLUSIONS

Despite limitations, active case-finding in the eight different countries did not find an incidence of YF vaccine associated AEFIs that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated YF vaccine during preventive mass vaccination campaigns in YF endemic areas.

摘要

背景

已报告黄热病（YF）17D 疫苗接种后出现严重但罕见的不良事件（AEFI），包括严重过敏反应、黄热病疫苗相关神经疾病（YEL-AND）和黄热病疫苗相关内脏疾病（YEL-AVD）。黄热病流行国家 YEL-AND 和 YEL-AVD 的发生频率大多未知。

方法

2007 年至 2010 年，贝宁、喀麦隆、几内亚、利比里亚、马里、塞内加尔、塞拉利昂和多哥 8 个非洲国家实施了大规模黄热病预防接种运动。每个国家都建立了疫苗药物警戒系统，其中包括标准病例定义、收集和运输生物标本的程序以及审查数据和分类病例的国家专家委员会。所有国家的工作人员都接受了培训，实验室能力也有所扩大。

结果

共有超过 3800 万人接种了黄热病疫苗，报告了 3116 例 AEFI，其中 164 例（5%）被归类为严重病例。其中，22 例（13%）被归类为黄热病疫苗反应，包括 11 例（50%）过敏反应，6 例（27%）疑似 YEL-AND，5 例（23%）疑似 YEL-AVD。每 10 万剂疫苗接种的发生率为所有报告的 AEFI 为 8.2，任何严重 AEFI 为 0.43，黄热病疫苗相关 AEFI 为 0.058，过敏反应为 0.029，YEL-AND 为 0.016，YEL-AVD 为 0.013。我们的发现受到操作挑战的限制，包括难以获得推荐的生物标本，导致实验室评估不完整、未知病例确定以及工作人员培训和经验水平的差异。