Microcephaly and other severe fetal brain defects (congenital Zika syndrome) caused by the Zika virus have prompted an urgent effort to develop and license a safe and efficacious vaccine. Yet, that effort has run up against one of the most formidable barriers in vaccine research: pregnant women are almost always excluded from clinical trials for fear that the intervention may harm the fetus. This article analyzes the existing regulatory framework for vaccines intended for use during pregnancy in an effort to identify ways the process may be reconsidered in light of recent public health emergencies that had a disproportionate effect on pregnant women.
Sam F. Halabi,
Zika and the Regulatory Regime for Licensing Vaccines for Use During Pregnancy, 26 Annals of Health Law 20
Available at: https://scholarship.law.missouri.edu/facpubs/707