Chambers Christina D, Johnson Diana L, Xu Ronghui, Luo Yunjun J, Louik Carol, Mitchell Allen A, Schatz Michael, Jones Kenneth L
Department of Pediatrics, University of California San Diego, La Jolla, CA, United States; Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.
Department of Pediatrics, University of California San Diego, La Jolla, CA, United States.
Vaccine. 2016 Aug 17;34(37):4443-9. doi: 10.1016/j.vaccine.2016.06.054. Epub 2016 Jul 20.
There is a need for pregnancy safety information overall and for each seasonal formulation of the influenza vaccine.
As part of the cohort arm of the Vaccines and Medications in Pregnancy Surveillance System, vaccine-exposed and unexposed women in the U.S. or Canada were recruited during pregnancy in the 2010-2014 vaccine seasons and followed to pregnancy outcome. For the four seasons combined, crude and adjusted relative risks (RRs) were estimated with 95% confidence intervals (CIs) for major birth defects overall and infants small for gestational age. Crude and adjusted hazard ratios (HRs) were estimated with 95% CIs for spontaneous abortion and preterm delivery. Specific influenza season subanalyses were also conducted.
Of 1730 women, 1263 were exposed to an influenza vaccine and 467 were unexposed to any influenza vaccine. Among pregnancies with first-trimester exposure excluding lost-to-follow-up, 26/457 (5.7%) resulted in an infant with a major birth defect compared to 13/427 (3.0%) in the unexposed (RR 1.87, 95% CI 0.97, 3.59). No specific pattern of defects was evident in the vaccine-exposed cohort. The overall risk of spontaneous abortion was not elevated (HR 1.09, 95% CI 0.49, 2.40). Adjusted HRs for preterm delivery approximated 1.0 (adjusted HR 1.23, 95% CI 0.75, 2.02). RRs for small for gestational age infants on weight, length and head circumference ranged from 1.19 to 1.49 with all CIs including 1. Season-by-season analyses resulted in variation by season; however, estimates were based on small numbers.
Combining the 2010-2014 influenza seasons, we found a moderately elevated RR for major birth defects overall, but no evidence of a specific pattern; 95% CIs included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine.
总体上以及针对流感疫苗的每种季节性配方都需要妊娠安全性信息。
作为妊娠监测系统中疫苗与药物队列研究的一部分，在美国或加拿大，于2010 - 2014年疫苗接种季节招募了孕期接触过疫苗和未接触过疫苗的女性，并跟踪至妊娠结局。对于合并的四个季节，估计了总体主要出生缺陷和小于胎龄儿的粗相对风险（RR）及校正相对风险，并给出95%置信区间（CI）。估计了自然流产和早产的粗风险比（HR）及校正风险比，并给出95%置信区间。还进行了特定流感季节的亚组分析。
在1730名女性中，1263名接触过流感疫苗，467名未接触过任何流感疫苗。在妊娠早期接触疫苗且未失访的孕妇中，26/457（5.7%）的婴儿有主要出生缺陷，而未接触疫苗组为13/427（3.0%）（RR 1.87，95% CI 0.97，3.59）。在接触疫苗的队列中未发现明显的特定缺陷模式。自然流产的总体风险未升高（HR 1.09，95% CI 0.49，2.40）。早产的校正风险比约为1.0（校正HR 1.23，95% CI 0.75，2.02）。小于胎龄儿在体重、身长和头围方面的RR范围为1.19至1.49，所有置信区间均包含1。逐季分析结果显示各季节存在差异；然而，估计值基于小样本量。
综合2010 - 2014年流感季节的数据，我们发现总体主要出生缺陷的RR适度升高，但未发现特定模式的证据；95%置信区间包含1，这一发现可能是偶然因素导致。在合并的季节中，我们未发现有意义的证据表明接触季节性流感疫苗后自然流产或早产风险增加。
