Maternal and Infant Survival Following Ebola Infection: Their Exclusion from Treatment and Vaccine Trials and “Primum non nocere”

Abstract

In the West Africa epidemic from a virus as lethal as Ebola, pregnant women and their infants were denied access to potentially life-saving drugs and an experimental vaccine. From the discovery of the Ebola virus in 1976 to the start of the West African Ebola epidemic, pregnant women had a case fatality rate of approximately 90%; no fetus, neonate, or mother-baby pair had survived the infection; and there were no effective drugs or vaccines. When Ebola virus disease (EVD) began its spread throughout Sierra Leone, Guinea, and Liberia, numerous protocols for clinical trials of promising highly effective antiviral drugs and vaccines were evaluated, but the protocols excluded pregnant women and their infants from participation. This exclusion of pregnant women from clinical trials had a long precedent, but had been temporarily halted during the AIDS pandemic. Despite the expected 90% mortality rate for pregnant women and total loss of life for their fetuses and newborns, decisions were made to withhold potentially life-saving treatments from them. Fortunately, a single newborn was able to receive experimental treatment outside of the clinical trial while being cared for by Medecins Sans Frontieres—she became the only known neonate to survive EVD. This chapter discusses the survival statistics of pregnant women and fetuses with Ebola infection from both previous outbreaks and the West African epidemic and addresses issues surrounding the exclusion of pregnant women and their infants from receiving potentially life-saving treatment during clinical trials.