Regan Annette K, Sullivan Sheena G, Arah Onyebuchi A
School of Nursing and Health Professions, University of San Francisco, San Francisco, CA, United States; Department of Epidemiology, Fielding School of Public Health, UCLA, Los Angeles, CA, United States.
Department of Epidemiology, Fielding School of Public Health, UCLA, Los Angeles, CA, United States; WHO Collaborating Centre for Reference and Research on Influenza, Royal Melbourne Hospital, and Department of Infectious Diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.
Vaccine. 2024 Dec 2;42(26):126256. doi: 10.1016/j.vaccine.2024.126256. Epub 2024 Sep 10.
Although numerous studies support the safety of influenza vaccination during pregnancy, fewer studies have evaluated the risk of miscarriage or considered the effect of prior immunization.
Using national de-identified administrative claims data from the Optum Labs Data Warehouse, we conducted a claims-based cohort study of 117,626 pregnancies between January 2009 and December 2018. We identified pandemic A(H1N1)pdm09 and seasonal influenza vaccinations using CPT codes. Fetal loss was defined as miscarriage, medical termination, or stillbirth as identified by ICD-10-CM diagnostic codes. Cox proportional hazard models treating influenza vaccination as a time-varying exposure, weighted for loss-to-follow-up and stratified by baseline probability of vaccination, were used to model the risk of fetal loss by exposure to influenza vaccine.
About 31.4 % of the cohort had a record of influenza vaccination; 10.0 % were vaccinated before pregnancy only, 17.8 % during pregnancy only, and 3.6 % before and during pregnancy. The risk of miscarriage was 39 % lower among those vaccinated during pregnancy compared to unvaccinated (adjusted hazard ratio, aHR 0.61; 95 % CI 0.50, 0.74) and was similar for medical termination or stillbirth (HR 0.69; 95 % CI 0.45, 1.03 and aHR 0.99; 95 % CI 0.76, 1.30, respectively). Similar results were observed for women who received the vaccine before and during pregnancy. We observed little to no association between vaccination before pregnancy and risk of miscarriage (HR 0.98; 95 % CI 0.76, 1.26), medical termination (HR 1.02; 95 % CI 0.46, 2.24), or stillbirth (HR 1.14, 95 % CI 0.77, 1.69).
Influenza vaccination was not associated with an increased risk of fetal loss. These results support the safety of influenza vaccine administration even when administered before or early during pregnancy.
尽管众多研究支持孕期接种流感疫苗的安全性，但评估流产风险或考虑既往免疫影响的研究较少。
利用Optum实验室数据仓库中经过去识别处理的全国行政索赔数据，我们对2009年1月至2018年12月期间的117,626例妊娠进行了一项基于索赔的队列研究。我们使用CPT编码识别甲型H1N1流感大流行疫苗和季节性流感疫苗。胎儿丢失定义为根据ICD - 10 - CM诊断编码确定的流产、医学引产或死产。将流感疫苗接种视为随时间变化的暴露因素，采用Cox比例风险模型，对失访进行加权，并按疫苗接种的基线概率分层，以模拟接触流感疫苗后胎儿丢失的风险。
约31.4%的队列有流感疫苗接种记录；10.0%仅在孕前接种，17.8%仅在孕期接种，3.6%在孕前和孕期均接种。与未接种者相比，孕期接种者的流产风险降低了39%（调整后风险比，aHR 0.61；95%置信区间0.50，0.74），医学引产或死产的风险相似（HR分别为0.69；95%置信区间0.45，1.03和aHR 0.99；95%置信区间0.76，1.30）。孕前和孕期均接种疫苗的女性也观察到类似结果。我们观察到孕前接种与流产风险（HR 0.98；95%置信区间0.76，1.26）、医学引产风险（HR 1.02；95%置信区间0.46，2.24）或死产风险（HR 1.14，95%置信区间0.77，1.69）之间几乎没有关联。
流感疫苗接种与胎儿丢失风险增加无关。这些结果支持了流感疫苗接种的安全性，即使在孕前或孕期早期接种也是如此。
