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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. Fil: Krubiner, Carleigh B.. University Johns Hopkins; Estados Unidos Fil: Faden, Ruth R.. University Johns Hopkins; Estados Unidos Fil: Karron, Ruth A.. University Johns Hopkins; Estados Unidos Fil: Little, Margaret O.. University Of Georgetown; Estados Unidos Fil: Lyerly, Anne D.. University of North Carolina; Estados Unidos Fil: Abramson, Jon S.. University Wake Forest; Estados Unidos Fil: Beigi, Richard H.. Magee-Womens Hospital of University of Pittsburgh Medical Center; Estados Unidos Fil: Cravioto, Alejandro R.. Universidad Nacional Autónoma de México; México Fil: Durbin, Anna P.. University Johns Hopkins; Estados Unidos Fil: Gellin, Bruce G.. Sabin Vaccine Institute; Estados Unidos Fil: Gupta, Swati B.. IAVI; Estados Unidos Fil: Kaslow, David C.. PATH; Estados Unidos Fil: Kochhar, Sonali. Global Healthcare Consulting; India Fil: Luna, Florencia. Facultad Latinoamericana de Ciencias Sociales; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Saenz, Carla. Pan American Health Organization; Estados Unidos Fil: Sheffield, Jeanne S.. University Johns Hopkins; Estados Unidos Fil: Tindana, Paulina O.. Navrongo Health Research Centre; Ghana Fil: The Prevent Working Group. No especifíca

Viscerotropic disease (VTD) is defined as acute multiple organ system dysfunction that occurs following vaccination. The severity of VTD ranges from relatively mild multisystem disease to severe multiple organ system failure and death. The term VTD was first used shortly after the initial published reports in 2001 of febrile multiple organ system failure following yellow fever (YF) vaccination. To date, VTD has been reported only in association with YF vaccine and has been thus referred to as YF vaccine-associated viscerotropic disease (YEL-AVD).

Dengue is a rapidly growing public health threat with approximately 2.5billion people estimated to be at risk. Several vaccine candidates are at various stages of pre-clinical and clinical development. Thus far, live dengue vaccine candidates have been administered to several thousands of volunteers and were well-tolerated, with minimal short-term safety effects reported in Phase I and Phase II clinical trials. Based on the natural history of dengue, a theoretical possibility of an increased risk of severe dengue as a consequence of vaccination has been hypothesized but not yet observed. In October 2011, the World Health Organization (WHO) convened a consultation of experts in dengue, vaccine regulation and vaccine safety to review the current scientific evidence regarding safety concerns associated with live attenuated dengue vaccines and, in particular, to consider methodological approaches for their long-term evaluation. In this paper we summarize the scientific background and methodological considerations relevant to the safety assessment of these vaccines. Careful planning and a coordinated approach to safety assessment are recommended to ensure adequate long-term evaluation of dengue vaccines that will support their introduction and continued use.