FDA reviewers propose routes to Ebola vaccine approval

FDA's Vaccines and Related Biological Products advisory committee will meet on May 12 to discuss the types of efficacy data that can be used to support the approval of Ebola vaccines. In briefing documents released ahead of Tuesday's meeting, FDA reviewers said the direct evaluation of Ebola vaccines using clinical endpoint studies may not be feasible due to a significant decline in Ebola infection rates.

Reviewers said approval can be based on human trials using a surrogate endpoint, such as immune response, that is "reasonably likely" to predict clinical benefit. ...