Title: Pregnant Women Should be Included in Zika Virus Vaccine Research

The inclusion of pregnant women in Zika virus vaccine research is crucial to solving the international health crisis, according to new guidance published today by Georgetown’s Kennedy Institute of Ethics (KIE) and two other universities.

KIE, the Johns Hopkins Berman Institute of Bioethics and the University of North Carolina’s UNC Center for Bioethics were awarded a £1.2 million grant from the Wellcome Trust in 2016 to develop ethical guidelines to responsibly and equitably include pregnant women in research related to public health emergencies.

The most devastating consequence of the Zika virus – Congenital Zika Syndrome (CZS) – is caused by infection with the virus during pregnancy.

“Restricting women’s access to a potentially efficacious vaccine during pregnancy is not only unethical, it’s dangerous,” says Maggie Little, KIE director and professor of philosophy. “We cannot afford to exclude pregnant women from this research, because they are most affected by the virus.”

According to the Centers for Disease Control and Prevention, Texas and Florida are among the areas with a high risk for the Zika virus, along with parts of Central and South America, Africa and Asia.

Moral Imperatives

The guidance centers around three moral imperatives that provide the ethical urgency for pursuing Zika virus vaccine research with pregnant women:

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.

The research team convened a 15-person working group of experts in science, health policy and research ethics from around the globe who in turn consulted with 60 leading experts in vaccine science and immunology to deliver the ethics guidance for including the needs and interests of pregnant women in the Zika research agenda.

The guidance, called “Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion and Evidence Generation,” is the work of the Ethics Working Group on ZIKV Research & Pregnancy.

Little says the new guidance gives policymakers, funders, researchers, oversight bodies, regulatory authorities and the global public health community concrete steps needed to address the issue.

Fair Treatment

“We argue that inclusion in, not exclusion from, clinical research is necessary to ethically respond to the needs of pregnant women in the face of the global Zika virus crisis,” Little says. “Pregnant women deserve to be treated fairly in the public health research enterprise. We must ensure that they are not only provided with evidence-based care, but that they are not unjustly asked to assume the risks of our reluctance to conduct research with them.”

The universities’ multiyear project, called PREVENT (Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies) will continue to address emerging epidemic threats.

“History has demonstrated time and time again that the health needs of pregnant women and their offspring are not included in research during public health emergencies,” Little says. “We want to change that by offering clear evidence that the global research and public health community should pursue and prioritize the development of Zika virus vaccines that will be acceptable for use by pregnant women in the context of an outbreak.”