FDA advisory committee debates safety and efficacy standards for a coronavirus vaccine - The Washington Post
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.