Global Vaccine Development, GlaxoSmithKline (GSK) Biologicals, Parc de la Noire Epine, Avenue Fleming 20, 1300 Wavre, Belgium.
Vaccine. 2011 Aug 26;29(37):6358-65. doi: 10.1016/j.vaccine.2011.04.114. Epub 2011 May 17.
Infection with influenza virus during pregnancy poses a significant risk of complications for both mother and fetus. During the H1N1 2009 pandemic, pregnant women constituted one of the priority groups for vaccination in many countries, creating a need for close monitoring of the safety of the vaccine in pregnant women. We present findings from an analysis of a cohort of pregnant women (N=267) from a prospective, observational, post-authorization safety study of the AS03-adjuvanted split virion H1N1 (2009) pandemic vaccine. There were 265 known pregnancy outcomes with 261 live births, four spontaneous abortions with no congenital anomalies, and no stillbirths. There were six live births with congenital anomalies, of which one was diagnosed before vaccination. A total of 247 women (94.6%), of whom four had twin pregnancies, delivered at term, and 14 women (5.4%), of whom two had twin pregnancies, delivered preterm (between Weeks 24 and 36 of gestation), with three of them (1.1%) occurring before 32 weeks (very preterm). Twenty-one neonates (8.1%) had a low birth weight (<2.5 kg), of whom nine (3.5%) were term neonates. The prevalence of all outcomes was in line with the expected rates. The adverse events reported were consistent with the events anticipated to be reported by this study population. No adverse events of special interest were reported. The results of this analysis suggest that exposure to the AS03 adjuvanted H1N1 (2009) vaccine during pregnancy does not increase the risk of adverse pregnancy outcomes including spontaneous abortion, congenital anomalies, preterm delivery, low birth weight neonates, or maternal complications. Although limited in size, the fully prospective nature of the safety follow-up of these women vaccinated during pregnancy is unique and offers an important degree of reassurance for the use of the AS03 adjuvanted H1N1 (2009) vaccine in this high risk group for H1N1 infection.
孕妇感染流感病毒会给母婴带来严重的并发症风险。在 2009 年 H1N1 大流行期间，许多国家都将孕妇列为优先接种疫苗的人群之一，这就需要密切监测孕妇接种疫苗的安全性。我们报告了一项针对在一项前瞻性、观察性、上市后安全性研究中接种了 AS03 佐剂的裂解病毒 H1N1（2009）流感疫苗的孕妇队列（N=267）的分析结果。有 265 例已知妊娠结局，其中 261 例活产，4 例自然流产且无先天畸形，无死产。有 6 例活产伴有先天畸形，其中 1 例在接种疫苗前诊断。共有 247 名妇女（94.6%）分娩，其中 4 名怀有双胞胎，14 名妇女（5.4%）分娩早产（妊娠 24 至 36 周之间），其中 3 名（1.1%）发生在 32 周之前（极早产）。21 名新生儿（8.1%）体重低（<2.5kg），其中 9 名（3.5%）为足月新生儿。所有结局的发生率与预期发生率一致。报告的不良事件与该研究人群预期报告的事件一致。未报告特殊关注的不良事件。这项分析结果表明，在怀孕期间接触 AS03 佐剂的 H1N1（2009）疫苗不会增加不良妊娠结局的风险，包括自然流产、先天畸形、早产、低出生体重儿或母亲并发症。尽管规模有限，但对这些怀孕期间接种疫苗的妇女进行安全性随访的完全前瞻性性质是独特的，为在这一高感染 H1N1 风险人群中使用 AS03 佐剂的 H1N1（2009）疫苗提供了重要程度的保证。
