School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada; Children's Hospital of Eastern Ontario (CHEO) Research Institute, Ottawa, Canada.
Children's Hospital of Eastern Ontario (CHEO) Research Institute, Ottawa, Canada.
Vaccine. 2021 Apr 1;39(14):1882-1886. doi: 10.1016/j.vaccine.2021.02.070. Epub 2021 Mar 2.
COVID-19 vaccines are now being deployed as essential tools in the public health response to the global SARS-CoV-2 pandemic. Pregnant individuals are a unique subgroup of the population with distinctive considerations regarding risk and benefit that extend beyond themselves to their fetus/newborn. As a complement to traditional pharmacovigilance and clinical studies, evidence to comprehensively assess COVID-19 vaccine safety in pregnancy will need to be generated through observational epidemiologic studies in large populations. However, there are several unique methodological challenges that face observational assessments of vaccination during pregnancy, some of which may be more pronounced for COVID-19 studies. In this contribution, we discuss the most critical study design, data collection, and analytical issues likely to arise. We offer brief guidance to optimize the quality of such studies to ensure their maximum value for informing public health decision-making.
COVID-19 疫苗现在被用作全球 SARS-CoV-2 大流行公共卫生应对的重要工具。孕妇是人群中的一个独特亚组，她们的风险和收益考虑不仅涉及自身，还延伸到胎儿/新生儿。作为对传统药物警戒和临床研究的补充，需要通过大型人群的观察性流行病学研究来获得全面评估 COVID-19 疫苗在妊娠期间安全性的证据。然而，观察性评估妊娠期间疫苗接种存在几个独特的方法学挑战，其中一些对于 COVID-19 研究可能更为突出。在这篇文章中，我们讨论了可能出现的最关键的研究设计、数据收集和分析问题。我们提供了简短的指导，以优化此类研究的质量，确保其为公共卫生决策提供最大价值。
