PREVENT Says Include Pregnant Women in Vaccine Research

Bioethics and healthcare experts are calling on the scientific community to enable pregnant women to receive vaccines against emerging infectious diseases. 

An international coalition of experts says ‘it's time for a change.’ 

The ‘Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance on Preparedness, Research & Response,’ report presents steps to shake up the vaccine development ‘status quo’. 

This new report is a product of the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group.  

Which provides a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. 

This PREVENT report specifies 22 concrete recommendations, organized around 3 key areas: public health preparedness, R&D, and vaccine delivery. 

An example of these recommendations is ‘make it the default practice during an epidemic to offer vaccines to pregnant and lactating women and get their input on research and vaccine deployment decisions.’ 

A 2nd example is the current Zika virus outbreak. 

The rapid spread of the Zika virus galvanized the global public health community toward the development of preventive vaccines.

One of the most significant consequences of a infection is Congenital Zika Syndrome, which is a result of a Zika infection during pregnancy. 

Therefore, to test the efficacy of Zika vaccines on women and their future babies, women should be integrated into vaccine development, says this Guidance.

Currently, the Centers for Disease Control and Prevention (CDC) says the ‘Risk to a developing fetus (from an approved) vaccination of the mother during pregnancy is theoretical.’   

‘No evidence exists of risk to the fetus from vaccinating pregnant women with inactivated virus or bacterial vaccines or toxoids.’ 

However, ‘Live vaccines administered to a pregnant woman pose a theoretical risk to the fetus.’ 

‘Therefore, live, attenuated virus and live bacterial vaccines generally are contraindicated during pregnancy,’ says the CDC. 

PREVENT is a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy, in consultation with a variety of external experts and stakeholders. 

The Guidance recommendations are directed at a range of disciplines, 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, and civil society organizations. 

PREVENT is a grant-funded project led by faculty at Johns Hopkins University alongside co-investigators at Georgetown University and the University of North Carolina at Chapel Hill, with external contributions from Working Group Members. The PREVENT Project is funded by the Wellcome Trust (203160/Z/16/Z). 

PREVENT corresponding Author: Carleigh B. Krubiner: [email protected]