New Guidance: Pregnant Women and Vaccines against Emerging Epidemic Threats

The Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) working group has issued a new guidance that addresses the ethical, just and respectful inclusion of pregnant women in the development and deployment of vaccines against emerging pathogens.

Historically, pregnant women have been excluded as potential investigational vaccine recipients during outbreaks, because there is little or no safety data for the unborn fetus. However, the multidisciplinary group of experts that compose PREVENT have re-evaluated the automatic exclusion of pregnant women from vaccine  trials and from the receipt of vaccines during outbreaks, citing the risk of infection outweighs the risks of receiving the investigational vaccine.

The decision by public health governing bodies to omit pregnant women from receiving an investigational Ebola vaccine during an outbreak in North Kivu led to an op ed piece in STAT, co-authored by members of PREVENT, CIR Director Dr. Ruth Karron, Berman Institute of Bioethics founder Dr. Ruth Faden and Center for Global Development policy fellow Carleigh Krubiner.  The piece brought additional awareness of the need to reconsider current policies that exclude pregnant women from receiving vaccines that may save the lives of both the mother and fetus.

The new guidance is composed of 22 recommendations meant to help pregnant women and their offspring benefit from advances in vaccine technologies and to protect them from emerging and re-emerging pathogenic threats, as stated in its vision.