Regulators get creative on Ebola vaccine testing as infections decline
- Ebola infection rates have been declining recently, making it harder for Ebola vaccine developers to recruit for clinical trials. But researchers and regulators are finding creative ways to submit data to the FDA to support approvals, Bloomberg reports.
- Ebola vaccines are being developed by a variety of companies and agencies, including the National Institutes of Health (NIH), GlaxoSmithKline, Merck and NewLink Genetics Corp, and Johnson & Johnson.
- Since the Ebola outbreak, more than 21,000 people have been infected and almost 8,700 people have died. However, in the last week, there were only eight cases of Ebola reported in Liberia.
The fact that the waning Ebola epidemic is making it challenging to recruit for clinical trials is a good problem to have. Nonetheless, vaccine makers need to move forward in order to gain FDA approval for vaccines, which could help prevent another Ebola outbreak.
One strategy that is being used is combining human safety and immune response from trials in Liberia and Sierra Leone with efficacy data from earlier animal studies. In addition, a late-stage, large-scale trial of various Ebola vaccines could soon begin. If this study moves forward, roughly 27,000 human subjects will participate.