Department of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Vaccine. 2013 Sep 13;31(40):4448-58. doi: 10.1016/j.vaccine.2013.06.032. Epub 2013 Jun 14.
The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A (H1N1) vaccines (pH1N1). This pandemic provided the opportunity to evaluate the risk of Guillain-Barré syndrome (GBS), which has been an influenza vaccine safety concern since the swine flu pandemic of 1976, using a common protocol among high and middle-income countries. The primary objective of this project was to demonstrate the feasibility and utility of global collaboration in the assessment of vaccine safety, including countries both with and without an established infrastructure for vaccine active safety surveillance. A second objective, included a priori, was to assess the risk of GBS following pH1N1 vaccination.
The primary analysis used the self-controlled case series (SCCS) design to estimate the relative incidence (RI) of GBS in the 42 days following vaccination with pH1N1 vaccine in a pooled analysis across databases and in analysis using a meta-analytic approach.
We found a relative incidence of GBS of 2.42 (95% CI 1.58-3.72) in the 42 days following exposure to pH1N1 vaccine in analysis of pooled data and 2.09 (95% CI 1.28-3.42) using the meta-analytic approach.
This study demonstrates that international collaboration to evaluate serious outcomes using a common protocol is feasible. The significance and consistency of our findings support a conclusion of an association between 2009 H1N1 vaccination and GBS. Given the rarity of the event the relative incidence found does not provide evidence in contradiction to international recommendations for the continued use of influenza vaccines.
2009 年新型大流行性流感 A（H1N1）病毒在全球范围内的传播，导致单价 2009 年流感 A（H1N1）疫苗（pH1N1）的加速生产和分发。这次大流行提供了一个机会，可以使用高收入和中等收入国家之间的共同方案来评估自 1976 年猪流感大流行以来一直是流感疫苗安全问题的格林-巴利综合征（GBS）的风险。该项目的主要目的是展示在评估疫苗安全性方面进行全球合作的可行性和实用性，包括在有和没有建立疫苗主动安全监测基础设施的国家。第二个目标是在 pH1N1 疫苗接种后评估 GBS 的风险，这是事先确定的。
主要分析使用自我对照病例系列（SCCS）设计，以估计 pH1N1 疫苗接种后 42 天内 GBS 的相对发病率（RI），在汇总分析中使用荟萃分析方法进行分析。
我们发现，在对汇总数据的分析中，在 pH1N1 疫苗接种后 42 天内，GBS 的相对发病率为 2.42（95%CI 1.58-3.72），而使用荟萃分析方法的相对发病率为 2.09（95%CI 1.28-3.42）。
本研究表明，使用共同方案评估严重结局的国际合作是可行的。我们研究结果的重要性和一致性支持了 2009 年 H1N1 疫苗接种与 GBS 之间存在关联的结论。鉴于该事件的罕见性，发现的相对发病率并没有提供与国际继续使用流感疫苗的建议相矛盾的证据。
