Exploring regulatory data sets of the Comirnaty vaccine - 11d

Using the placebo arm data - you never had it so good

Randomised controlled trials have their limits. For example, you cannot randomise healthy people to an intervention or real placebo and keep them blinded and untreated for a long time to assess long-term effectiveness or harms profile.

 These days, this principle is routinely abused, with the assumption that everything tested is “safe and effective” and that participants cannot be deprived of “safe and effective” interventions for too long. However, the principle is, in theory, ethically correct.

But this is another story tied to active “placebos”, which we will develop in a subsequent post.

In post 11c, we listed the definitions of the Cominarty cases according to Protocol C4591001 (PF-07302048) Statistical Analysis Plan (SAP), part of Clinical_Study_Report_Part_2 and Appendices at pdf page 529 of the same document.

Exploring regulatory data sets of the Comirnaty vaccine - 11c

As our readers know, C 4591001 was Comirnaty's Phases 1/2/3 registration trial. Because of the vagueness of the definitions and the use but incomplete reporting of PCR positi…