Department of Pediatrics, University of California San Diego, La Jolla, CA, United States; Rady Children's Hospital, San Diego, CA, United States; Department of Family and Preventive Medicine, University of California San Diego, La Jolla, CA, United States; Clinical Translational Research Institute, University of California San Diego, La Jolla, CA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.
Vaccine. 2013 Oct 17;31(44):5026-32. doi: 10.1016/j.vaccine.2013.08.097. Epub 2013 Sep 7.
There is a need for additional information on the fetal risks and relative safety of the pandemic H1N1 monovalent or trivalent influenza (pH1N1)-containing vaccines in women exposed during pregnancy.
To assess risks and relative safety of the pH1N1-containing vaccines, we conducted a prospective cohort study of pH1N1-vaccine-exposed and unexposed comparison women residing in the U.S. or Canada who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. For exposure to the pH1N1 vaccine, adjusted relative risks (RRs) and 95% confidence intervals (CIs) were estimated for major birth defects and infants small for gestational age. Adjusted hazard ratios (HRs) and 95% CIs were estimated for spontaneous abortion and preterm delivery for time-varying exposure.
There were 1032 subjects available for analysis; 841 women were exposed to a pH1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed (adjusted RR 0.79, 95% CI 0.26-2.42). The HR for spontaneous abortion was not elevated (adjusted HR 0.92, 95% CI 0.31-2.72). Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy (3.28, 95% CI 1.25-8.63), specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. Adjusted RRs for small for gestational age infants on weight and length approximated 1.0.
For the 2009-12 influenza seasons combined, we found no meaningful evidence of increased RR or HR for major birth defects, spontaneous abortion, or small for gestational age infants. There was some evidence of an increased HR for preterm delivery following pH1N1-influenza vaccine exposure; however the decrease in gestational age on average was approximately three days.
需要更多信息来评估在妊娠期间暴露于大流行 H1N1 单价或三价流感（pH1N1）疫苗的孕妇所面临的胎儿风险和相对安全性。
为了评估 pH1N1 疫苗的风险和相对安全性，我们对 2009 年 10 月至 2012 年 8 月期间在美国或加拿大招募的妊娠期间接种 pH1N1 疫苗的孕妇和未接种 pH1N1 疫苗的对照孕妇进行了前瞻性队列研究。对于 pH1N1 疫苗的暴露，主要出生缺陷和胎儿小于胎龄的调整相对风险（RR）和 95%置信区间（CI）进行了估计。对于时间变化的暴露，自发性流产和早产的调整风险比（HR）和 95%CI 进行了估计。
有 1032 名受试者可供分析；841 名孕妇在妊娠期间接种了 pH1N1 疫苗，191 名孕妇在妊娠期间未接种任何流感疫苗。328 例妊娠早期暴露中，有 9 例（2.7%）婴儿患有重大出生缺陷，而 188 例未暴露（调整 RR 0.79，95%CI 0.26-2.42）。自发性流产的 HR 并未升高（调整 HR 0.92，95%CI 0.31-2.72）。在整个孕期任何时候暴露于 pH1N1 疫苗时，早产的调整 HR 均升高（3.28，95%CI 1.25-8.63），尤其是在 1 或 2 孕期。然而，暴露妊娠的平均胎龄减少约三天。根据体重和长度，小于胎龄儿的调整 RR 接近 1.0。
对于 2009-12 年流感季节，我们没有发现与重大出生缺陷、自发性流产或胎儿小于胎龄相关的 RR 或 HR 增加的有意义证据。pH1N1 流感疫苗暴露后早产的 HR 略有增加；但是，平均胎龄减少约三天。
