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British MHRA Expected Many Vaccine Adverse Reactions, in October 2020

The British MHRA expected many vaccine adverse reactions, in October 2020, months before the vaccine rollout started. The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a tender for “an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs).”

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.

But they went ahead with the vaccine program anyway and passed it off as “Safe and Effective,” even though they knew it would cause serious harm.

The tender was issued by the MHRA Buyer Organisation and on 2 March 2022, it was still displayed on the European Union’s Tenders Electronic Daily (TED) website. TED is a Supplement to the Official Journal of the EU.

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 tender document has been stored in multiple places in case they try to erase this evidence by removing it from the tender website. View or Download it here.

The contract was awarded to the only applicant, Genpact (UK) for 1.5 million GBP.

Adverse-reaction-tender-2020-OJS207-506291-en

mhra expected many adverse reactions

MHRA expected many adverse reactions but went ahead anyway.