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The Role of Data Analysis in the VAERS System
FDA had the latitude to require that vaccine sponsors implement more rigorous data capture for safety. But they elected not to, okay? So they made a conscious decision not to. In clinical research, we don't do this. We get all the reports. And what we... If we're doing a structured clinical trial, we ensure that every single serious adverse event is carefully reported and carefully evaluated. A physician has to make a judgment call as to whether it is not or is possibly or is definitely associated with drug administration. The bias has to be. Anybody, if you think about this for just a nanosecond, okay, if our goal is to ensure safety, the bias has to