Pandemic Perspectives: COVID’s Unprecedented Experience With Emergency Use Authorizations
The US Food and Drug Administration's EUA pathway has seen more use in the therapeutic and vaccine space during the current pandemic than it has in its entire 16-year history and in many cases the potential eligible populations for the authorized products are far larger than past EUAs. Pink Sheet infographic compares details of past and present EUAs.
You may also be interested in...
FDA policy experts Jesse Goodman, Mark McClellan, Peter Lurie, David Bowen, Patti Zettler, and Aaron Kesselheim suggest ideas and points to consider in using the COVID-19 experience to assess whether standards for EUAs should be adjusted.
Surprising move to have VRBPAC debate offering mRNA boosters to everyone 18 and up, less than one month after the panel shot that down for Pfizer’s vaccine, thus stalling the White House’s plan for a broad booster rollout, was driven internally by the FDA, a senior health official said.
Though not designed to facilitate inter-group comparisons, a preprint study of heterologous and homologous boosting with the three US available COVID-19 vaccines indicate Johnson and Johnson primary vaccines may get greater protection from an mRNA booster.