Breaking news (well it should be). The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) has awarded a 1.5 million GBP, no bid contract to UK company Genpact for Artificial Intelligence to: process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed.”
The contract was agreed on 14th Sept 2020 and the MHRA justifies the no-bid aspect of the contract because of exceptional circumstances:
” The procurement falls outside the scope of application of the directive
For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool.
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.
Reasons of extreme urgency — the MHRA recognises that its planned procurement process for the SafetyConnect programme, including the AI tool, would not have concluded by vaccine launch. Leading to a inability to effectively monitor adverse reactions to a Covid-19 vaccine.
Events unforeseeable — the Covid-19 crisis is novel and developments in the search of a Covid-19 vaccine have not followed any predictable pattern so far.”
The MHRA is fully aware that, given the circumstances, any COVID19 vaccine rolled out to the public will not be properly safety tested. This contract suggests that “safety testing” will be done in the field and in real time. The vaccinated population will become the “safety test”. The MHRA already has a monitoring process in place to record adverse effects of the current vaccines dispensed in the UK. That they expect the “volume of ADRs that will be generated by a Covid-19 vaccine” to exceed their ability “to process these ADRs effectively” and in turn “hinder its ability to identify any potential safety issues with the Covid-19 vaccines” and that this “represents a direct threat to patient life and public health”, is of grave concern and should be public knowledge. Along with the fact that the manufacturers and those delivering any COVID19 vaccine are exempt from any legal liability whatsoever.
None of the people suffering the volume of ADRs suggested by the MHRA, will have any recourse to compensation of any kind from the vaccine industry.
This information should be made crystal clear to the public BEFORE any COVID19 vaccine is rolled out, so that those who want it can make a fully informed choice.
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