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Adverse event reporting rates following tetanus-diphtheria and tetanus toxoid vaccinations: data from the Vaccine Adverse Event Reporting System (VAERS), 1991-1997

机译:破伤风-白喉和破伤风类毒素疫苗接种后的不良事件报告率:疫苗不良事件报告系统(VAERS)的数据,1991-1997年

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摘要

Since 1966, the Advisory Committee on Immunization Practices (ACIP) has recommended tetanus-diphtheria toxoid (Td) be used instead of single antigen tetanus toxoid (TT) because, while both vaccines protect against tetanus, only Td protects against diphtheria. Despite this recommendation, approximately 2.5 million doses of TT were distributed annually from 1991 to 1997. One possible explanation for the continued use of TT is concern about the relative safety of Td. Small clinical trials found Td to be associated with a higher rate of local vaccine-associated adverse events (VAEs) than TT. To determine if the findings from the trials would hold up on a larger scale, we compared the rate of reporting to the Vaccine Adverse Event Reporting System (VAERS), a passive reporting system, after either vaccine from 1991 to 1997. There were 40 reports per million doses of Td, and 27 reports per million doses of TT, for a reporting rate ratio of 1.4. Reporting rates to VAERS are lower than the rates of VAEs identified in the clinical trials, but the magnitude of the difference in VAEs following TT versus Td is similar. While reporting rates are lower after TT than Td, rates of reported VAEs after both vaccines are low.
机译:自1966年以来,免疫实践咨询委员会(ACIP)推荐使用破伤风-白喉类毒素(Td)代替单抗原破伤风类毒素(TT),因为虽然两种疫苗都可以预防破伤风,但只有Td可以预防白喉。尽管有此建议,但从1991年至1997年,每年仍分发约250万剂TT。继续使用TT的一种可能解释是对Td的相对安全性的担忧。小型临床试验发现,与TT相比,Td与局部疫苗相关的不良事件(VAE)发生率更高。为了确定试验的结果是否能够更大规模地应用,我们比较了从1991年至1997年使用任一疫苗后的疫苗不良事件报告系统(VAERS)的报告率,这是一种被动报告系统。每百万剂Td剂量,每百万剂TT剂量有27次报告,报告比率为1.4。向VAERS报告的比率低于临床试验中确定的VAE比率,但是TT与Td相比,VAE的差异幅度相似。 TT后的报告率低于Td,但两种疫苗后报告的VAE发生率均较低。

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