Zika virus, H1N1, 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 research & development (R&D) efforts to combat emerging and re-emerging infectious diseases. This is especially true for vaccine R&D, since vaccines are often a critical component in the public health response to epidemic threats.
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. 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. Moreover, biomedical research with pregnant women is ethically complicated. These challenges can become even more complex when vaccine research is conducted in response to emerging pathogens, with additional layers of urgency and uncertainty.
But developing the evidence base for vaccine use in pregnancy is important. This is because:
- Pregnancy alters metabolism and immune response, which can impact vaccine effectiveness
- There may be significant benefits of vaccinating during pregnancy
- Pregnant women are likely to have unintentional vaccine exposures in any immunization campaign targeting reproductive-aged women
- Vaccines can present safety risks that are unique to pregnancy, including fetal risks
- Understanding actual risks and benefits of candidate vaccines can critically inform care and the broader public health response
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 vaccine research and development for emerging epidemic threats. Guidance is also needed on the conditions under which it is ethically acceptable, if not required, to include pregnant women in vaccine trials. These questions are of particular urgency as the pace of vaccine development accelerates and investments are being made to develop vaccines against a range of dangerous pathogens – many of which have severe presentations in pregnancy.
Increasingly, efforts are underway to prospectively invest in vaccine development in order to be better equipped to handle emerging epidemic threats in the future. There is an opportunity, now, to forge a path for a more inclusive vaccine R&D agenda that will ensure pregnant women and their offspring fairly benefit from these investments and scientific advancements. To do this will require placing the needs of pregnant women and their offspring squarely in the sights of those who shape R&D priorities, as well as navigating the challenges and ethical complexities of conducting research with pregnant women.
Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) 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 R&D for priority pathogens and emerging epidemic threats. Our approach is multi-disciplinary, bringing together a team of scholars and scientists with expertise in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research.
In our first year, we developed guidance specific to the Zika crisis: Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation. This Guidance is the product of The Ethics Working Group on ZIKV Research & Pregnancy, an interdisciplinary group of international experts in vaccinology, maternal and child health, public health and ethics.
We are now expanding our focus to develop a more generalizable ethics framework to guide the vaccine R&D enterprise toward more inclusive approaches that will ensure pregnant women and their offspring can fairly benefit from vaccines against emerging pathogens and epidemic threats.