Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload
Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.
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As FDA Advisers Grow Comfortable With EUAs, Harder Decisions On J&J’s Vaccine Fall To States, Individuals
J&J’s COVID-19 vaccine sails through its US FDA advisory panel, but that just means the subpopulation efficacy questions need to be wrestled with by other public health space, as CDC and the states must figure out the best way to distribute multiple vaccines with differing efficacy profiles, regimens and storage requirements.
From surprisingly contentious to surprisingly unanimous, VRBPAC's favorable votes have grown from 17 to 21 over the course of three meetings on coronavirus vaccines.
Safety data does not look to be a barrier J&J vaccine’s authorization, but FDA says it will recommend surveillance for further evaluation of thromboembolic events. The agency says it currently cannot rule out a causal relationship with the vaccine. One of these cases prompted a study hold last fall.