McCarthy Natalie L, Gee Julianne, Sukumaran Lakshmi, Weintraub Eric, Duffy Jonathan, Kharbanda Elyse O, Baxter Roger, Irving Stephanie, King Jennifer, Daley Matthew F, Hechter Rulin, McNeil Michael M
Centers for Disease Control and Prevention, Atlanta, Georgia;
Centers for Disease Control and Prevention, Atlanta, Georgia; Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia;
Pediatrics. 2016 Mar;137(3):e20152970. doi: 10.1542/peds.2015-2970. Epub 2016 Feb 1.
This study evaluates the potential association of vaccination and death in the Vaccine Safety Datalink (VSD).
The study cohort included individuals ages 9 to 26 years with deaths between January 1, 2005, and December 31, 2011. We implemented a case-centered method to estimate a relative risk (RR) for death in days 0 to 30 after vaccination.Deaths due to external causes (accidents, homicides, and suicides) were excluded from the primary analysis. In a secondary analysis, we included all deaths regardless of cause. A team of physicians reviewed available medical records and coroner's reports to confirm cause of death and assess the causal relationship between death and vaccination.
Of the 1100 deaths identified during the study period, 76 (7%) occurred 0 to 30 days after vaccination. The relative risks for deaths after any vaccination and influenza vaccination were significantly lower for deaths due to nonexternal causes (RR 0.57, 95% confidence interval [CI] 0.38-0.83, and RR 0.44, 95% CI 0.24-0.80, respectively) and deaths due to all causes (RR 0.72, 95% CI 0.56-0.91, and RR 0.44, 95% CI 0.28-0.65). No other individual vaccines were significantly associated with death. Among deaths reviewed, 1 cause of death was unknown, 25 deaths were due to nonexternal causes, and 34 deaths were due to external causes. The causality assessment found no evidence of a causal association between vaccination and death.
Risk of death was not increased during the 30 days after vaccination, and no deaths were found to be causally associated with vaccination.
本研究评估疫苗安全数据链(VSD)中疫苗接种与死亡之间的潜在关联。
研究队列包括年龄在9至26岁之间、于2005年1月1日至2011年12月31日期间死亡的个体。我们采用以病例为中心的方法来估计接种疫苗后0至30天内死亡的相对风险(RR)。主要分析排除了外部原因(事故、凶杀和自杀)导致的死亡。在次要分析中,我们纳入了所有原因导致的死亡。一组医生查阅了可用的医疗记录和验尸官报告,以确认死亡原因并评估死亡与疫苗接种之间的因果关系。
在研究期间确定的1100例死亡中,76例(7%)发生在接种疫苗后0至30天。因非外部原因导致的死亡(RR分别为0.57,95%置信区间[CI]0.38 - 0.83,以及RR为0.44,95%CI 0.24 - 0.80)和所有原因导致的死亡(RR分别为0.72,95%CI 0.56 - 0.91,以及RR为0.44,95%CI 0.28 - 0.65),接种任何疫苗和流感疫苗后死亡的相对风险均显著降低。没有其他单一疫苗与死亡有显著关联。在审查的死亡病例中,1例死亡原因不明,25例死亡是由非外部原因导致的,34例死亡是由外部原因导致的。因果关系评估未发现疫苗接种与死亡之间存在因果关联的证据。
接种疫苗后30天内死亡风险未增加,且未发现死亡与疫苗接种存在因果关联。