How do you test an Ebola vaccine when almost no one has Ebola?
- Pharma companies running Ebola clinical trials in West Africa are facing some daunting data challenges as the epidemic wanes. Liberia has been declared Ebola-free and there are only a handful of cases in Guinea and Sierra Leone.
- Ebola vaccines are being developed by a variety of companies. The current focus is on testing two vaccines, one from GlaxoSmithKline, and the other from Merck & NewLink Genetics.
- Clinical trial experts are concerned that although the vaccines have been declared safe, there simply are not enough people with Ebola to obtain robust efficacy results.
The epidemic that killed 11,000 people in West Africa, with the first outbreak in December 2013, has waned to the point that there are not enough qualified volunteers to include in clinical trials. While having zero cases is preferable to having a lot of qualified volunteers, government officials and medical experts are looking ahead and are concerned about a potential future outbreak. Despite the fact that there are very few cases of Ebola now, the goal is to be prepared for the next outbreak.
Although GSK and Merck/NewLink have not been able to ramp up trials due to insufficient numbers, Mapp Biopharma has been testing its drug, ZMapp. Going forward, international medical experts will be drawing up protocols and modified R&D frameworks to compensate for a lack of study participants. The goal remains to approve an Ebola vaccine that is safe, effective, and durable.