'Warp Speed’ Vaccine Trial Network Aims For Both Harmony And Velocity
Infographic depicts how Operation Warp Speed is harmonizing the study designs of COVID-19 vaccine candidates to make it easier to compare safety and efficacy.
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The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
Guidance on COVID-19 vaccine development and licensure appears to set a precedent in specifying the clinical efficacy rate for a product approval; agency also takes accelerated approval off the table for now and says emergency use authorization may be granted only after safety and efficacy have been demonstrated.
Ahead of the vaccine advisory committee, requests to FDA range from public health groups opposing emergency use authorizations to industry seeking labeling guidance on EUA products.