Immunization Safety Office (VSD), Centers for Disease Control and Prevention, Atlanta, Georgia.
Immunization Safety Office (VSD), Centers for Disease Control and Prevention, Atlanta, Georgia.
Vaccine. 2017 Dec 4;35(48 Pt B):6643-6648. doi: 10.1016/j.vaccine.2017.10.034. Epub 2017 Oct 20.
Evidence supports the safety of the recommended childhood immunization schedule as a whole. However, additional research is warranted as parents' refusing or delaying vaccinations has increased in recent years. All-cause mortality has been identified as a priority outcome to study in the context of the recommended immunization schedule.
We included children born January 1, 2004 through December 31, 2009, enrolled in the Vaccine Safety Datalink (VSD) from birth through 18 months of age. We examined vaccination patterns during the first 18 months of life among 8 vaccines, and identified deaths occurring between 19 and 48 months of age. We excluded children with complex chronic conditions, contraindications to vaccination, and deaths due to injuries, congenital anomalies, or diseases with onset prior to 19 months of age. We calculated mortality rates among children with different patterns of immunization, and incidence rate ratios (IRR) using the Cox proportional hazards model for children vaccinated according to the schedule versus undervaccinated children, adjusting for outpatient healthcare utilization, influenza vaccination, sex, and VSD site.
Among 312,388 children in the study, 199,661 (64%) were vaccinated according to the schedule, and 112,727 (36%) were delayed or not vaccinated for at least one vaccine dose. Of 18 deaths eligible for analysis, 11 occurred in children following the schedule (2.28 per 100,000 person-years), and seven occurred in undervaccinated children (2.57 per 100,000 person-years). Mortality rates among children following the schedule were not significantly different from those of undervaccinated children when excluding deaths with unknown causes (IRR = 1.29, 95% CI = 0.33-4.99), as well as when including deaths with unknown causes (IRR = 0.84, 95% CI = 0.32-2.99).
Although there were few deaths, our results do not indicate a difference in risk of all-cause mortality among fully vaccinated versus undervaccinated children. Our findings support the safety of the currently recommended immunization schedule with regard to all-cause mortality.
有证据支持推荐的儿童免疫计划作为一个整体的安全性。然而,近年来,家长拒绝或推迟接种疫苗的情况有所增加,因此需要进一步研究。全因死亡率已被确定为推荐免疫计划背景下需要研究的优先结果。
我们纳入了 2004 年 1 月 1 日至 2009 年 12 月 31 日期间出生的儿童,他们在出生至 18 个月期间参加了疫苗安全数据链接(VSD)。我们检查了 8 种疫苗在生命的头 18 个月期间的接种模式,并确定了 19 至 48 个月之间发生的死亡。我们排除了患有复杂慢性疾病、疫苗接种禁忌以及因受伤、先天性异常或发病前 19 个月内的疾病导致死亡的儿童。我们计算了不同免疫模式的儿童的死亡率,并使用 Cox 比例风险模型计算了按计划接种疫苗的儿童与未充分接种疫苗的儿童之间的发病率比(IRR),并根据门诊医疗保健利用、流感疫苗接种、性别和 VSD 地点进行了调整。
在研究的 312388 名儿童中,有 199661 名(64%)按照计划接种了疫苗,有 112727 名(36%)至少有一剂疫苗延迟或未接种。在符合分析条件的 18 例死亡中,有 11 例发生在按计划接种疫苗的儿童中(每 100000 人年 2.28 例),有 7 例发生在未充分接种疫苗的儿童中(每 100000 人年 2.57 例)。在排除死因不明的死亡(IRR=1.29,95%CI=0.33-4.99)和包括死因不明的死亡(IRR=0.84,95%CI=0.32-2.99)时,按计划接种疫苗的儿童的死亡率与未充分接种疫苗的儿童相比没有显著差异。
尽管死亡人数很少,但我们的结果并未表明完全接种疫苗与未充分接种疫苗的儿童在全因死亡率方面的风险有差异。我们的研究结果支持目前推荐的免疫计划在全因死亡率方面的安全性。