Ethics, pregnancy, and ZIKV vaccine research & development

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]. [...]biomedical research with pregnant women is ethically complicated. To ensure that our recommendations were grounded in the most up-to-date state of the science and public health response to ZIKV, we conducted consultations with over 60 leading experts in vaccine science and immunology, flaviviruses and general virology, clinical trial design, public health and emergency preparedness, maternal-fetal medicine, obstetrics, pediatrics, research ethics, and legislative and regulatory affairs concerning vaccines and biologics. Previous experience with immunization programs underscores that not all women will be immunized ahead of pregnancy, leaving them and their offspring unprotected [7]. [...]we now know that the risks of ZIKV-related harms persist throughout pregnancy and that immunization could offer significant benefits beyond the first trimester. [...]because women of childbearing potential will be a primary target population for ZIKV vaccine programs, it is inevitable that sizeable numbers of pregnant women will be inadvertently administered vaccines deemed not acceptable for use in pregnancy. [...]even for vaccine candidates not anticipated to be acceptable for pregnancy, data about vaccine use in pregnancy are critically important.