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Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation

The rapid spread of the Zika virus (ZIKV) has galvanized the global public health community toward development of ZIKV vaccines. The most dire consequence of ZIKV infection, congenital ZIKV syndrome (CZS), is a result of infection during pregnancy. As a consequence, pregnant women figure prominently in global concerns about ZIKV. They should also figure prominently in ZIKV vaccine development, but the way forward is not well established. Significant questions remain about what specifically is required to ensure that these interests are adequately protected and fairly taken into account in ZIKV vaccine research. Guidance is also needed on the conditions under which is it ethically acceptable, if not required, to include pregnant women in ZIKV vaccine trials.

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Suggested citation:

The Ethics Working Group on ZIKV Research & Pregnancy. Pregnant Women & the Zika
Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence

Generation. Baltimore, MD: June 2017.
    *Corresponding Author: Carleigh Krubiner (ckrubiner@jhu.edu)

Production of this guidance is part of a multi-year project funded by the UK’s Wellcome Trust [203160/Z/16/Z]. The Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) project is committed to developing concrete, actionable, consensus-driven ethics guidance on how to equitably include the interests of pregnant women and their offspring in vaccine research and development (R&D) for priority pathogens and emerging epidemic threats.

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The guidance was authored by members of the Ethics Working Group on ZIKV and Pregnancy, an interdisciplinary group led by investigators at three major U.S. universities which seeks ethical solutions to ensure that the health needs of pregnant women and their offspring are appropriately included in research efforts addressing emerging public health crises.

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