Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response

This document offers 22 recommendations for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in vaccine preparedness, research and development (R&D), and vaccine delivery. It is a product of a multidisciplinary, international team of 17 experts specialising in bioethics, maternal immunisation, maternal-fetal medicine, obstetrics, paediatrics, philosophy, public health, and vaccine research and policy, in consultation with a variety of external experts and stakeholders.

The PREVENT Working Group contends that "There is growing recognition that the failure to attend fairly to the health interests of pregnant women in biomedical research is unacceptable. The World Health Organization (WHO), Pan American Health Organization (PAHO), Council for International Organizations of Medical Sciences (CIOMS), American College of Obstetrics and Gynecology (ACOG), and various U.S. [United States] federal agencies are advocating for the inclusion of the interests of pregnant women and their offspring in biomedical research, as are increasing numbers of bioethicists..."

The following excerpts from the document highlight recommendations directly related to communication:

• "Health information systems and infectious disease surveillance systems should be strengthened and integrated to ensure that data relevant to maternal, obstetric, and newborn health outcomes can inform scientific and public health responses to emerging pathogenic threats....For example, the Global Network for Women's and Children's Health Research launched a prospective, population-based registry of pregnancies across 7 low- and middle-income country (LMIC) sites to establish better reporting systems on important pregnancy and perinatal health indicators....Additionally, mHealth technologies and other relevant apps should be used as needed in systematic data collection efforts."
• "Evidence-based strategies to promote confidence about vaccination in pregnancy should be developed and implemented ahead of outbreaks, including stakeholder engagement with health care providers, women, their families, and their communities....There are many drivers of vaccine confidence in general and in pregnancy more specifically. The WHO SAGE Vaccine Hesitancy Working Group developed a model of determinants of 'vaccine hesitancy' that was structured around three domains: (1) contextual influences - including the roles of religion, culture, gender, and the media environment; (2) individual and group influences - including personal perceptions of vaccine risks and benefits, experiences and interactions with health providers, and influences of family members and peers; and, (3) vaccine and vaccination-specific issues - which entail specific aspects related to characteristics of a vaccine and how it is delivered..."
• "Communication plans should be developed for clear, balanced, and contextualized dissemination of vaccine study findings, recommendations for use in pregnancy, and any pregnancy-specific adverse events." Communication strategies are offered for 3 distinct contexts:
  1. Communicating about vaccine trials and research findings - "The need for effective and contextualized communication begins with early evidence generated in non-clinical studies and clinical trials....The communication plan should include any findings suggestive of efficacy and safety in pregnancy. It should also ensure that findings of adverse events are contextualized by background rates for these outcomes, as well as by the potential harms of infection to pregnant women and their offspring. Communications should also be transparent about the evidence available regarding use of a particular vaccine in pregnancy....Engagement with traditional and new media is necessary in advance of and during outbreaks. Media play a critical role in providing the public with real-time information about the epidemic and response and also often report research findings as well. Risk communication planning may include table-top exercises to train reporters, editors, and publishers about background rates of adverse obstetric and neonatal events to mitigate sensationalist stories and avoid false attribution of adverse events to vaccine use."
  2. Communicating vaccine recommendations in pregnancy - "During outbreaks and epidemics, public health authorities, recommending bodies, and professional associations will be determining whether a vaccine should be offered during pregnancy, and if so, whether the recommendation is specific to pregnancy trimester. Those making this determination should communicate the recommendation and the reasons behind it as clearly as possible to health care providers, affected communities, and pregnant women."
  3. Communicating adverse events in pregnancy during outbreak response - "[M]any things can go wrong over the course of pregnancy into early infancy, and some may be inappropriately attributed to the vaccine. The mishandling of risk communication of suspected pregnancy-specific adverse events during an outbreak or epidemic can lead to significant harms to pregnant women and their offspring, including women choosing to forego use of beneficial vaccines or unnecessarily seeking to terminate wanted pregnancies..."
• "To help ensure systematic and enduring change in the treatment of pregnant women in global vaccine policy and practices, the World Health Organization should convene a consultation of relevant stakeholders and experts. The Consultation should identify specific strategies to establish for pregnant women the presumption of inclusion in both vaccine research and deployment, including whether a dedicated, standing expert group is needed."
• "When there is a limited supply of vaccine against a pathogenic threat that disproportionately affects pregnant women, their offspring, or both, or when only one vaccine among several is appropriate for use in pregnancy, then pregnant women should be among the priority groups to be offered the vaccine....the reasons why some groups are prioritized should be communicated clearly to the public. Transparency is crucial to sustaining public trust during epidemics..."

Please consult the document for the remainder of the recommendations, which are directed at a range of actors, including global and national policymakers, regional and national regulatory authorities, funders and sponsors, vaccine manufacturers, research institutions, trial networks and research groups, individual researchers, oversight bodies, ethics review committees, community advisory boards, civil society organisations, and the media.