FDA Advisory Committee Discusses Novel Coronavirus Vaccine Safety, Efficacy Standards In All-Day Meeting
Washington Post: FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine
“Vaccine experts on Thursday rigorously debated the Food and Drug Administration’s planned standards for clearing a coronavirus vaccine quickly for broad use, discussing what level of evidence would be sufficient to establish safety and effectiveness. The FDA advisory committee, in an all-day virtual meeting, did not consider any specific vaccine. The session served in large part as a venue for the agency to try to reassure the public that any vaccine will be held to a high standard, not the relatively low bar used this year for emergency use authorization for treatments. The FDA said that though it probably will grant emergency use authorizations — which can be handed out faster than full approvals — for the early vaccines, it will use robust criteria similar to those applied in regular approvals. But committee members, and some individuals during the public hearing part of the meeting, weren’t all convinced…” (McGinley/Johnson, 10/22).