The challenge

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 serious and often disproportionate risks underscore the critical need to proactively consider the interests of pregnant women and their offspring in efforts to combat epidemic threats. This is especially true for vaccines, essential tools in the public health response to infectious diseases.

Historically, the needs of pregnant women have not been adequately represented in the
development of biomedical interventions, including vaccines.

Despite increasing support of maternal immunization strategies and efforts to develop certain vaccines specifically targeted to pregnant women, the vast majority of new vaccine products are rarely designed with pregnant women in mind. Moreover, widespread failure to appropriately include pregnant women in vaccine research means that evidence about safety and efficacy in pregnancy has been limited and late in coming. As a result, in numerous outbreaks and epidemics, pregnant women have been denied opportunities to receive vaccines that would have protected them and their offspring from the ravages of these diseases.

There are many causes for this widespread exclusion, 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 and vaccine campaigns are 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

Guidance is needed to ensure that the needs of pregnant women and their offspring are fairly addressed, in new approaches to public health preparedness, in vaccine research and development (R&D), and in vaccine delivery.

 

THe OPPORTUNITY

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 and have epidemic responses that ensure pregnant women and their offspring fairly benefit from investments and scientific advancements that generate new effective vaccines.

 

OUR WORK

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.

In our second year, we expanded upon our initial recommendations to address the broader context of emerging and re-emerging pathogens, with 22 concrete recommendations, organized around three key areas: public health preparedness, R&D, and vaccine delivery. This Guidance, Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance on Preparedness, Research & Response, provides a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens.

 
 

A multi-year project funded by the Wellcome Trust