Determining Which of Several Simultaneously Administered Vaccines Increase Risk of an Adverse Event.
Determining Which of Several Simultaneously Administered Vaccines Increase Risk of an Adverse Event.
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DOI：
10.1007/s40264-020-00967-8
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发表时间：
2020-10
期刊：
影响因子：
4.2
通讯作者：
Kulldorff M
中科院分区：
文献类型：
--
作者：
Wang SV;Stefanini K;Lewis E;Newcomer SR;Fireman B;Daley MF;Glanz JM;Duffy J;Weintraub E;Kulldorff M
儿童免疫接种计划通常涉及每次就诊多次疫苗接种。当同时（同一天）接种疫苗后观察到不良事件的风险增加时，可能很难确定是什么引发了不良事件。该方法论文讨论了一个系统过程，以确定同时施用的疫苗中哪种最有可能导致观察到的不良事件风险增加。我们使用文献中的一个例子，其中在接种疫苗一天后观察到癫痫发作的风险过高，但当天的疫苗接种模式使得很难辨别哪些疫苗可能引发不良事件。我们使用模拟来说明系统识别过程，该模拟保留了在接种疫苗的经验组中观察到的同时接种疫苗的模式。我们模拟了白喉-破伤风-无细胞百日咳 (DTaP) 和肺炎球菌结合物 (PCV) 对疫苗接种后第二天癫痫发作风险的“真实”影响。我们改变了疫苗的独立效应和交互效应（乘法尺度）。将这一过程应用于模拟数据后，我们评估了经验队列中疫苗接种一天后癫痫发作的风险。在所有模拟中，我们都能够确定哪些疫苗会导致过度风险。在经验数据中，我们将时间表中所有疫苗与癫痫发作的关联范围缩小到三种可能的候选疫苗，即 DTaP、PCV 和/或 B 型流感嗜血杆菌 (HiB)（p < 0.01，当所有 3 种疫苗同时接种时的归因风险：每 100,000 人中有 5 例）。解开它们与癫痫发作的关系需要更大的样本或更多的组合用药变化。当这三者均不服用时，没有观察到额外的风险。概述的过程可以提供有关单独和同时接种疫苗的潜在风险程度的宝贵信息。应使用独立数据以及基于生物学、统计独立的假设进一步研究关联性。
Childhood immunization schedules often involve multiple vaccinations per visit. When increased risk of an adverse event is observed after simultaneous (same-day) vaccinations, it can be difficult to ascertain which triggered the adverse event. This methods paper discusses a systematic process to determine which of the simultaneously administered vaccine(s) are most likely to have caused an observed increase in risk of an adverse event. We use an example from the literature where excess risk of seizure was observed one day after vaccination, but same-day vaccination patterns made it difficult to discern which vaccine(s) may trigger the adverse event. We illustrate the systematic identification process using a simulation that retained the observed pattern of simultaneous vaccination in an empirical cohort of vaccinated children. We simulated “true” effects for diphtheria-tetanus-acellular pertussis (DTaP) and pneumococcal conjugate (PCV) on risk of seizure the day after vaccination. We varied the independent and interactive effects of vaccines (on the multiplicative scale). After applying the process to simulated data, we evaluated risk of seizure one day after vaccination in the empirical cohort. In all simulations, we were able to determine which vaccines contributed to excess risk. In empirical data, we narrowed the association with seizure from all vaccines in the schedule to three likely candidates, DTaP, PCV, and/or Haemophilus influenzae type B (HiB) (p < 0.01, attributable risk when all 3 were administered together: 5 per 100,000). Disentangling their associations with seizure would require a larger sample or more variation in the combinations administered. When none of these three were administered, no excess risk was observed. The process outlined could provide valuable information on the magnitude of potential risk from individual and simultaneous vaccinations. Associations should be further investigated with independent data as well as biologically based, statistically independent hypotheses.
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