Our ongoing exploration of the regulatory data sets of the Comirnaty vaccine is a crucial endeavour.
It's time to recap our progress.
A lot of information needs a bit of time to be absorbed. As Tom explained, there is a lot on the plate and a lot more to come.
On March 21st, we initiated a crucial step by asking if a reliable mortality data set specifically related to mRNA vaccine exposure is available.
We started looking at regulatory submissions that follow an internationally recognised format agreed upon by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Clinical study reports (CSRs) are one of the five parts or modules that make up the Common Technical Document or CTD. We concentrated on data from the EU, UK, US and Canada. ·
Two studies started running in April 2020.
BNT16201 was a phase 1 dose-ranging study that was run in Germany.
C4591001 (called BNT162-02) was a rolling trial ending with 44,047 participants. It is an observer-blind design.
This meant that those giving the vaccine or the placebo could see the difference in the content of the ampoule or syri…
