Global Pharmacovigilance and Pharmacoepidemiology, Sanofi Pasteur, Toronto, Ontario, Canada.
Am J Obstet Gynecol. 2012 Sep;207(3 Suppl):S52-6. doi: 10.1016/j.ajog.2012.06.074. Epub 2012 Jul 9.
Pregnant women are at increased risk for hospitalization and death with influenza infection. The limited data on safety and effectiveness of influenza immunization in pregnancy emphasizes the importance of developing new and well-designed studies and of enhancing safety surveillance in pregnant women who are vaccinated with licensed influenza vaccines. Pregnancy exposure registries aim to collect and maintain data on the effects of marketed drugs and vaccines, when prescribed in pregnancy or during breastfeeding, on the women themselves and their children. Women who are prescribed a medication or vaccine as part of their routine clinical care can be enrolled directly or through reporting health care providers on a voluntary basis. Such registries generally are established for products that are intended for use by adolescents and adults and are a key component of the safety monitoring of licensed products. This article reviews some of the pregnancy registries that have been established for US-licensed vaccines, which includes influenza vaccines, and other postlicensure safety surveillance efforts for monitoring safety in vaccinated pregnant women.
孕妇在感染流感后住院和死亡的风险增加。关于流感免疫接种在妊娠期间的安全性和有效性的有限数据强调了开发新的和精心设计的研究以及加强对接种许可流感疫苗的孕妇的安全性监测的重要性。妊娠暴露登记旨在收集和维护关于在妊娠期间或哺乳期内处方上市药物和疫苗对妇女及其子女的影响的数据。接受规定药物或疫苗治疗的妇女可以直接或通过报告医疗保健提供者自愿参与登记。此类登记通常针对供青少年和成年人使用的产品设立，是许可产品安全性监测的重要组成部分。本文综述了已为美国许可疫苗（包括流感疫苗）建立的一些妊娠登记处，以及其他上市后安全性监测工作，以监测接种疫苗的孕妇的安全性。
