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.
To address these questions, we received funding from the Wellcome Trust to form the Ethics Working Group on ZIKV Research & Pregnancy. The Working Group came to consensus on three key imperatives, each with accompanying concrete recommendations. The first imperative and its recommendations address the importance of prioritizing and incentivizing development of a ZIKV vaccine that can be used by pregnant women. The second imperative and set of recommendations address the need for research specific to vaccine use in pregnancy for all ZIKV vaccines, with corresponding data collection efforts, in order to generate evidence that is critically needed to inform responsible public health policy and clinical practice affecting pregnant women. The third imperative and its recommendations address the importance of ensuring the fair inclusion of pregnant women in research studies carrying the prospect of direct benefit. These recommendations also take up best practices for involving key actors and experts in decision-making processes, responsibly communicating decisions and scientific findings to the public, and ensuring that pregnant women – as a class and as individuals – are given appropriate respect.
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
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.