2020-12-16 6:33

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Government Prepares For Mass Adversory Drug Reaction To Covid Vaccine

The Government agencies responsible for public and personal healthcare need to be prepared for the reporting of adverse affects to patients from treatments or medicines they may be given whilst in hospitals and regarding drugs they may be given by GPs and clinicians.

The standard method of reporting adverse affects from drugs and medicines, including clinical equipment is the 'Yellow Card' system which takes its name from the yellow coloured cards that have been used since the reporting of adverse effects in healthcare prescribing was first set up.

However, what is new is that the MHRA in March of this year re-titled the system to Coronavirus Yellow Card Reporting Site.

So is the MHRA expecting a sudden rush of adverse reactions being reported to treatments and drugs used to treat Covid-19?

In itself, the change to the name evidences the answer to that question as being 'No' However, when you take into account that the MRHA has just put out an urgent call throughout the EU for the provision of an AI (artificial intelligence) programme in order for the processing of and analysis of, mass adverse reaction reporting; the evidence clearly moves towards the answer being 'YES'!

Pic: sections of the TED procurement request document - clikc to go to the website.
Click the pic to see the original document

Only stated criteria for the AI programme - price. Not accuracy, not ease of use, not security of the system, No - but merely price!!

The relevant paragraph entitle 'Type of procedure' from the above document is as follows:

Award of a contract without prior publication of a call for competition in the Official Journal of the European Union in the cases listed below

  • 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.

But the wording of the paragraph entitled 'Short description' is the real headline grabber:

The MHRA urgently seeks an Artificial Intelligence (AI) software tool 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.

Clearly, for this to be stated by the MHRA, there is a lot we are not being told about this sudden and newly developed vaccine!

Source: Official Journal of The EU - TED


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