Exploring regulatory data sets of the Comirnaty vaccine - 11c

Defining the effectiveness outcomes that matter from regulatory data

In post 11a, we listed the definitions of the Cominarty effectiveness outcomes that mattered to us, 

Exploring regulatory data sets of the Comirnaty vaccine - 11a

while in 11b, those that are reported in the package inserts.

Exploring regulatory data sets of the Comirnaty vaccine - 11b

Here, we report the same according to the regulatory data used as a main source, the original 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.

These all relate to trial C 4591001, the registration trial for Comirnaty.

We explained at the beginning why and how we would do our exploration in the first four posts of our series:

Crossed Harms

Exploring regulatory data sets of the Comirnaty vaccine - 2

Exploring regulatory data sets of the Comirnaty vaccine - 3

Here are the definitions given by the Pfizer documents