Department of Pediatrics, University of Turku, Turku, Finland.
Am J Obstet Gynecol. 2012 Sep;207(3):177.e1-8. doi: 10.1016/j.ajog.2012.07.007. Epub 2012 Jul 16.
The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy.
This was an observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated vs 2213 unvaccinated), with 3 month follow-up of neonates.
No maternal deaths or abortions occurred among the vaccinated women. No differences between the vaccinated and unvaccinated cohorts were observed for gestational diabetes, preeclampsia, stillbirth, low birthweight, neonatal deaths, or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard, 0.69; 95% confidence interval, 0.51-0.92). No differences were observed in rates of congenital malformations after vaccination in the first (2.1%), second (2.7%), or third (2.1%) trimesters.
There was no evidence of a safety risk for MF59-adjuvanted A/H1N1 vaccination in pregnant women; protection was observed against premature birth.
2009-2010 年 A/H1N1 大流行提供了一个独特的环境来研究 MF59 佐剂疫苗在妊娠期间的安全性。
这是一项针对 MF59 佐剂 A/H1N1 疫苗（Focetria）安全性的观察性队列研究，共纳入 4508 名孕妇（2295 名接种疫苗，2213 名未接种疫苗），对新生儿进行 3 个月随访。
接种疫苗的孕妇中无产妇死亡或流产。接种组与未接种组在妊娠糖尿病、子痫前期、死胎、低出生体重、新生儿死亡或先天性畸形方面无差异。接种疫苗的孕妇早产风险显著降低（调整后的比例风险为 0.69；95%置信区间为 0.51-0.92）。在妊娠第一（2.1%）、第二（2.7%）和第三（2.1%） trimester 接种疫苗后，先天性畸形的发生率无差异。
MF59 佐剂 A/H1N1 疫苗在孕妇中没有安全性风险的证据；观察到对早产有保护作用。
