Recombinant vesicular stomatitis virus vector vaccines for WHO blueprint priority pathogens

Fathi, Anahita; Dahlke, Christine; Addo, Marylyn M.

To date, pregnant women have been excluded from VSV-EBOV vaccine trials due to the safety concerns of administering a live-attenuated vaccine to this vulnerable population. At the same time, mortality rates are exorbitantly high with a lethality of around 90% in EVD-affected pregnant women and roughly 100% for the unborn children. Of those pregnant women who have inadvertently received the vaccine, no case outcomes have been published to date. However, 43 women reported pregnancies within 2 months of receiving the vaccine in a controlled phase II/III trial. Reassuringly, in this cohort pregnancy losses did not occur more often than in the control cohort and no congenital anomalies were observed. 37 The policy that pregnant women are not being offered the possibility of receiving VSV-EBOV has been a topic of repeated debate and controversy. 44, 45 MSF among others, have strongly argued in favor of inclusion of pregnant women, given the enormously high probability of death once infected. In view of the above, the Congolese Ministry of Health, backed by WHO, has recently announced Notes: All trials except for "rVSV-EBOV-01" are utilizing the vaccine candidate VSV-EBOV All vaccinations are given intramuscular at a dose of 2x10^7 PFU and as a single-shot, unless otherwise noted.