Researchers in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy and vaccine development and policy have collaborated to provide guidance that would allow pregnant women to be included in vaccine studies for emerging diseases.
Carleigh Krubiner, PhD, associate faculty member at the Johns Hopkins Berman Institute of Bioethics and project director at the Center for Global Development, said the guidance was spurred by the Zika epidemic, in which pregnant women “could not be ignored in the response.” After the group developed guidance on including pregnant women in the response to the Zika epidemic, they expanded their scope to include vaccination against other diseases, including Ebola, Lassa fever and “Disease X” — the name WHO gave to any pathogen that is currently unknown to cause human disease but represents a serious international threat.
“Unless there are good scientific or ethical reasons showing that the risks of vaccination are likely to be greater than the protection it may offer against an infectious disease threat, pregnant women should be offered the option to be vaccinated,” she told Infectious Diseases in Children. “Our 22 recommendations identify concrete solutions and actions to make this the reality, to close the evidence gap for pregnant women in epidemic responses and ensure that they have fair access to safe and effective vaccines just like other affected populations.”
During the recent Ebola outbreaks in the Democratic Republic of Congo, WHO advised that pregnant women should not receive investigational vaccines and treatments. In October 2018, the Strategic Advisory Group of Experts, which advises WHO on immunization policies, said there was insufficient evidence to recommend Ebola vaccination to pregnant women. However, survival rates are low for pregnant women infected with the virus (86%), and only one child infected with Ebola in utero is known to have survived.
To improve access to new vaccines during epidemics, Krubiner and colleagues recommended the following:
- Pregnant women should be offered the option to receive a vaccine by default.
- Vaccines need to be evaluated for safety and efficacy during pregnancy as early as possible during the clinical development process.
- Decisions regarding vaccination of pregnant women should include potential risks of vaccination, as well as the risk for infection to both mother and child if left unvaccinated.
- Inclusion and exclusion of pregnant women from immunization should be decided by those “with relevant expertise in maternal and neonatal health as well as in vaccinology and virology.”
- Pregnant women’s perspectives should be considered when vaccine research and deployment decisions are made that would affect their lives as well as their children’s lives.
The researchers acknowledged that their guidance may be difficult to follow, but “addressing inequities in biomedical research and public health rarely comes cheaply or without hard work.”
“Because the guidance addresses a complex problem that is reinforced by existing norms across multiple systems, the recommendations are targeted at a wide range of actors in a position to make needed changes, including policymakers, funders, vaccine researchers, ethics committees, regulatory authorities, providers and aid workers,” Krubiner said. “Essentially, we are calling for a paradigm shift in the way people think about pregnant women in the contexts of vaccine research and epidemic responses.” – by Katherine Bortz
PREVENT Working Group: Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research and Response. http://vax.pregnancyethics.org/prevent-guidance. Accessed: December 5, 2018.
Disclosure: Krubiner reports no relevant financial disclosures.