By Alexandra Ward
From the article:
Pregnant women have been routinely excluded from the vaccination research and development process, even though this vulnerable class is sometimes uniquely affected by infectious disease outbreaks.
In an effort to address and correct this inequity in vaccination coverage, a new report by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group, titled Pregnant Woman & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research and Response, is urging vaccination researchers, policymakers, and health groups across the globe to embark on a “paradigm shift” and change the default thinking when it comes to maternal vaccination.
Inclusion of pregnant women in vaccine research and development should be the default, not the exception, the group, funded by Wellcome Trust and made up of 17 multidisciplinary members, explained.
“There is nothing about pregnancy that makes women immune from infectious disease threats, and many infections pose increased risks to pregnant women themselves, the developing fetus, and usually both,” Carleigh Krubiner, PhD, a lead author of the report appointed at the Johns Hopkins Berman Institute of Bioethics and the Center for Global Development, told Contagion®. “[W]hen we’re developing vaccines to combat these infectious disease threats, we need to be considering pregnant women as part of the target population—when investment decisions are made and as we conduct the research to understand safety, immunogenicity, and ultimately, effectiveness.”
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If pregnant women are sometimes uniquely susceptible to contracting infectious diseases, and can suffer distinctive consequences with some illnesses, why the historical hesitancy to vaccinate them?
“There are many factors contributing to this near categorical exclusion, including overinflated perceptions of risk in pregnancy as well as liability concerns,” Dr. Krubiner explained. “This is despite the fact there is no evidence of harm associated with the vast majority vaccines given to pregnant women, even among the category of replication-competent vaccines that give rise to the greatest concerns.”
The PREVENT team acknowledged that changing the status quo will be an uphill battle, but the risk of not doing so could have far more catastrophic consequences.
“Paradigm shifts are rarely easy,” Dr. Krubiner told Contagion. “Adopting these recommendations will require significant changes in how people think about pregnant women in the context of research and in the delivery of medical interventions. It will also require institutions to adopt new processes and, in some cases, make additional investments. But changing from business as usual is critically important, both as a matter of social justice and to have successful public health responses to outbreaks.”
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