Originally Posted by
TheGrump
The whole point of the proposed system is to find and confirm causality between ADE (Adverse Drug Events) and a Covid-19 vaccine. Many ADE may well have no direct or relevant link to the vaccine, but be caused by other factors. Volume of data does NOT imply failure of a vaccine. Conversely, without a system, which can process all the data, serious issues (ADR) due to the vaccine may go undetected until it is too late. The pertinent section in the MHRA tender:
"Strictly necessary — it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health." Notice use of the word POTENTIAL.
All vaccines under development will go through the same procedure.