Serota Danielle E, Crooks Chelsea M, McGinty Emma E, Permar Sallie R, Riley Laura
Washington University School of Medicine, St. Louis, MO 63130, United States.
Department of Pediatrics, Weill Cornell Medicine, New York, NY 10065, United States.
Health Aff Sch. 2025 Feb 19;3(3):qxaf035. doi: 10.1093/haschl/qxaf035. eCollection 2025 Mar.
Pregnant and lactating women (PLW) have historically been excluded from vaccine research, creating inequities in vaccine access and uptake for PLW. US federal research policies create the framework for inclusion of diverse populations, including PLW, in research. We conducted a policy analysis and interviews ( = 29) with experts in vaccine research for PLW to characterize the existing policy landscape and to identify policy strategies to promote inclusion of PLW in vaccine trials. We integrated policy analysis and interview results to inform 5 policy recommendations. Current federal policy does not require or incentivize the inclusion of PLW in vaccine trials. The Food and Drug Administration (FDA) guidance on inclusion of PLW in vaccine and other clinical research is nonbinding and lacks clarity. Extant policies do not adequately allay liability concerns among vaccine developers. To address these concerns, we recommend that US Congress pass legislation authorizing the FDA to require inclusion of PLW in vaccine research; incentivize sponsors to complete timely vaccine studies in PLW; create a national no-fault compensation program for clinical research participants, including PLW; remove pregnancy from the "vulnerable population" designation in FDA human subjects regulations; and clarify existing federal regulations pertaining to clinical research with PLW.
历史上，孕妇和哺乳期妇女一直被排除在疫苗研究之外，这导致了她们在疫苗获取和接种方面的不平等。美国联邦研究政策为将包括孕妇和哺乳期妇女在内的不同人群纳入研究制定了框架。我们对从事孕妇和哺乳期妇女疫苗研究的专家进行了政策分析和访谈（n = 29），以描述现有政策格局，并确定促进孕妇和哺乳期妇女参与疫苗试验的政策策略。我们综合了政策分析和访谈结果，提出了5项政策建议。当前的联邦政策既不要求也不激励将孕妇和哺乳期妇女纳入疫苗试验。美国食品药品监督管理局（FDA）关于将孕妇和哺乳期妇女纳入疫苗及其他临床研究的指南没有约束力且缺乏明确性。现有政策未能充分缓解疫苗研发者对责任的担忧。为解决这些问题，我们建议美国国会通过立法，授权FDA要求将孕妇和哺乳期妇女纳入疫苗研究；激励赞助商及时完成针对孕妇和哺乳期妇女的疫苗研究；为包括孕妇和哺乳期妇女在内的临床研究参与者设立全国性的无过错补偿计划；从FDA人体受试者法规中的“弱势群体”指定中删除怀孕这一类别；并澄清与孕妇和哺乳期妇女临床研究相关的现有联邦法规。
