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They did not skip QA. The EMA (the European FDA equivalent) did not reduce the formal requirements for Covid vaccines compared to other vaccines. None of the Co
by funcDropShadow 5y ago
They did not skip QA. The EMA (the European FDA equivalent) did not reduce the formal requirements for Covid vaccines compared to other vaccines. None of the Covid vaccines have an emergency use authorization in the EU. They all went through the regular process. That process was made more parallel and more incremental. And it was obviously executed with the highest priority possible.
Those ideas are indeed used in the IT world, but they are successful ideas, and they are much older than the IT world. By incremental I mean, the rolling review used for the trials. I.e. the pharma companies would deliver regularly preliminary versions of the final report on the trial. Thereby, a lot of questions about the report can be asked and answered earlier than in a traditional review process after the trial has finished.