Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Avenue, Baltimore, MD, USA.
Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Avenue, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Vaccine. 2021 Jan 3;39(1):85-120. doi: 10.1016/j.vaccine.2019.01.011. Epub 2019 May 3.
Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely - and at times uniquely - affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group - a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy - in consultation with a variety of external experts and stakeholders.
寨卡病毒、流感和埃博拉病毒等疾病暴发,严重地、有时甚至是独特地影响到孕妇及其后代的健康利益,这引起了人们对传染病暴发的关注。这些例子也突显了积极考虑孕妇及其后代在疫苗研究和应对新发和再现传染病的努力中的重要性。从历史上看,孕妇及其后代在针对传染病威胁的疫苗研究议程和投资战略中,很大程度上被排除在外,这反过来又导致她们在暴发期间被排除在未来的疫苗接种运动之外。这种情况对孕妇及其后代是极不公平的,从公共卫生的角度来看,这也是存在问题的。为了确保孕妇及其后代的需求得到公平对待,需要采取新的公共卫生准备、疫苗研究和开发以及疫苗接种方法。本指南提供了 22 条具体建议,为在开发和部署针对新出现病原体的疫苗时,负责、公正和尊重地考虑孕妇的利益提供了路线图。本指南由疫苗、流行病和新技术妊娠研究伦理(PREVENT)工作组制定,该工作组由 17 名专家组成,涉及生物伦理学、孕产妇免疫、母胎医学、产科、儿科、哲学、公共卫生和疫苗研究与政策等多个领域。工作组还与各种外部专家和利益相关者进行了协商。