The Comirnaty Vaccine Files - Part 1

The evidence for provisional registration - structuring our review

Because of our experience with antivirals, we decided to avoid articles published in peer-reviewed literature and ignore media and diatribes published on the topic. In effect, we decided to focus on what regulators saw before granting provisional registration (which has different names given by various regulators).

This entailed an effort on two fronts. First, we must explain what regulatory data looks like, its functions, what it contains, and what some terms mean. Second, we have to record and present our findings in the data.

The importance of regulatory data lies in its structured and detailed nature compared to biomedical journal literature.

Because of the presence of publication bias, reporting bias of harms, lack of access of authors to "their own datasets" in our work on antivirals and the inconsistencies of the data presented to different regulators, we decided to ignore the published evidence initially and concentrate on the regulator and internal Glaxo and Roche clinical study…