Exploring regulatory data sets of the Comirnaty vaccine - 12

Focussing on the demographics of the registration trial

We reported that provisional licensing for Comirnaty was granted by various regulatory bodies in late 2021.

The necessary evidence was based on Study C4951001: A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-COV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals. 

Slowly - bit by bit - we are going through the clinical study report and regulators’ takes on its content. Before we go on, one of TTE’s contacts provided us with a leaflet she got through the letterbox:

Apologies for the poor quality of the reproduction. The leaflet urges people to be vaccinated with Spikewax or Comirnaty. Due to a lack of resources, we have focused on the latter and have a few comments.

The leaflet makes some claims (for example, that the vaccine - in this case, was tested before licensing). This is technically true, thanks to study C4951001. However, as followers of our series know, many …