Following the recent announcement from the WHO that Merck’s experimental Ebola vaccine V920 (rVSV-ZEBOV) will be offered to pregnant women in the Congo for the first time,
Paul Jeng, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view on vaccine testing during outbreaks:
“Until now, pregnant and lactating women have been excluded from ring vaccination campaigns in the Democratic Republic of the Congo (DRC) due to the fears that live or attenuated vaccines may imperil a developing fetus. While the reversal of this policy comes with inherent risks, it is a necessary and ethical step towards curbing the current Ebola epidemic, and provides a valuable opportunity to collect scientific data on vaccination during pregnancy.
“*GlobalData’s primary research indicates a wide-spread belief among key opinion leaders (KOLs) that the research norms for experimental product testing should be reassessed in the context of an outbreak. For instance, the mortality rate for pregnant women infected with Ebola in 2014 was up to 90%, indicating a pressing unmet need for Ebola prophylaxis in this population.
“GlobalData expects that V920 will become the first Ebola vaccine to be licensed by the FDA in 2019. The vaccine was previously tested in a trial of 4,539 close contacts of infected individuals during the 2015 Ebola outbreak in Guinea, although pregnant women were also excluded from participation at the time. Non-replicative vaccines considered to be safer for pregnant women are also in clinical development, including GlaxoSmithKline’s Phase III product GSK-3390107A, based on a Chimpanzee adenovirus vector.”