Ethics, pregnancy, and ZIKV vaccine research & development.

Abstract

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), results from 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. Historically, the needs of pregnant women have not been adequately represented in the development of biomedical interventions, including vaccines. New products are rarely designed with the specific needs of pregnant women in mind, and for many interventions, evidence about safety and efficacy in pregnancy is limited and late in coming, often many years after licensure [1]. Investigators have also been reticent to conduct interventional biomedical research with pregnant women. There are many causes for this reticence, including misinterpretations or overly cautious interpretations of what is allowed under research regulations and international norms, as well as concerns about legal liability [2,3]. Moreover, biomedical research with pregnant women is ethically complicated. Assessments of risk and prospect for benefit must take into account the interests of both the pregnant woman and the fetus, which are usually but not always aligned. In the case of ZIKV, the interests of pregnant women and their offspring do align. Pregnant women have the deepest interest in the health of their babies, and will suffer along with their children if CZS is not averted. Nevertheless, significant questions remain about what specifically is required to ensure that the interests of pregnant women and their offspring 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 trials. These questions are of particular urgency as the pace of vaccine development accelerates and threats to pregnant women and their offspring from new outbreaks continue [4].