Sudden and unexpected deaths after the administration of hexavalent vaccines (diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilius influenzae type b):: is there a signal?
Sudden and unexpected deaths after the administration of hexavalent vaccines (diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilius influenzae type b):: is there a signal?
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DOI：
10.1007/s00431-004-1594-7
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发表时间：
2005-02-01
影响因子：
3.6
通讯作者：
Giani, G
中科院分区：
文献类型：
--
作者：
von Kries, R;Toschke, AM;Giani, G
最近报告了与接种六价疫苗有关的暂时性死亡。本文的目的是评估这些时间关联是否可以归因于偶然性。两种六价疫苗接种后第1年和第2年内死亡的标准化死亡率(SMR)分别使用国家生命统计数据中的意外猝死(SODS)年率确定。根据个别疫苗的调查和销售数字，估计了SUD病例的分布和每月的疫苗接种量。进行了敏感性分析，以说明数据来源的局限性。对于其中一种疫苗，疫苗B，所有SMR都远低于1。A疫苗在出生第1年接种后第1天SMRS超过1，差异无统计学意义。但在出生后第2年，接种A疫苗后第1天内的SMR为31.3(95%可信区间3.8~113.1；观察2例，预期为0.06例)；接种后第2天内的SMR为23.5(95%CI4.8~68，6)(观察3例，预期为0.13例)。广泛的敏感性分析不能将这些发现归因于数据来源的限制。结论：这些基于自发报告的研究结果并不能证明接种疫苗与意外猝死之间存在因果关系。然而，它们构成了两种六价疫苗中的一种的信号，应促使加强对接种后意外死亡的监测。
Deaths in temporal association with vaccination of hexavalent vaccines have been recently reported. The objective of this paper is to assess whether these temporal associations can be attributed to chance. Standardised mortality ratios (SMR) for deaths within I to 28 days after administration of either of the two hexavalent vaccines in the 1st and 2nd year of life were determined using the respective annual rates for sudden unexpected deaths (SUDs) from the national vital statistics. The distribution of SUD cases and the vaccination uptake by month were estimated from surveys and sales figures for the individual vaccines. Sensitivity analyses were performed to account for limitations in the data sources. For one of the vaccines, Vaccine B, all SMRs were well below one. For the other, Vaccine A, SMRs exceeded one insignificantly on the 1st day after vaccination in the 1st year of life. In the 2nd year of life, however, the SMRs for SUD cases within I day of vaccination with vaccine A were 31.3 (95% CI 3.8-113.1; two cases observed; 0.06 cases expected) and 23.5 (95% Cl 4.8-68,6) for within 2 days after vaccination (three cases observed; 0.13 cases expected). Extensive sensitivity analyses could not attribute these findings to limitations of the data sources. Conclusion: These findings based on spontaneous reporting do not prove a causal relationship between vaccination and sudden unexpected deaths. However, they constitute a signal for one of the two hexavalent vaccines which should prompt intensified surveillance for unexpected deaths after vaccination.