A report completed by Institute Director and Senior Research Scholar Maggie Little and colleagues was recently featured in Science as the leading guidance on the issue of maternal immunization ethics and the Zika virus (ZIKV). The article, “Zika rewrites maternal immunization ethics,” discusses the importance of maternal immunization today, calling such immunizations “‘the next frontier.’”
Vaccines safe for pregnant women, particularly during their third trimester, are growing in importance across the medical community, pushing researchers to consider the ethical considerations when including pregnant women in vaccinations’ clinical trials. The article outlines various ZIKV vaccine clinical trails currently taking place and compares these trials with the recommendations and analyses provided by the research team’s report.
The report is a collaboration among disciplines and institutions, including the KIE, the Johns Hopkins Berman Institute of Bioethics, and the University of North Carolina’s UNC Center for Bioethics and is supported by the Wellcome Trust. The Johns Hopkins Berman Institute of Bioethics leads the project. Little and colleagues convened a 15-person working group of experts in science, health policy, and research ethics, whose input and expertise led the team to develop comprehensive ethics guidance on the responsible and equitable inclusion of pregnant women in research related to public health emergencies.
This guidance, released in June of this year, outlines three key moral imperatives to address the ethical urgency to pursue Zika virus vaccine research with pregnant women, each also outlined in Science’s discussion on the matter:
- Develop a Zika virus vaccine that can be responsibly and effectively used during pregnancy.
- Collect data that are specific to safety and the ability of a vaccine to effect an immune response in pregnant women to all Zika virus vaccines to which pregnant women may be exposed.
- Ensure pregnant women have fair access to participate in vaccine trials that offer a reasonably favorable ratio of research-related risks to potential benefits.