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Head To Head Coronavirus

Covid-19 vaccines: Should we allow human challenge studies to infect healthy volunteers with SARS-CoV-2?

BMJ 2020; 371 doi: (Published 09 November 2020) Cite this as: BMJ 2020;371:m4258

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Rapid Response:

Re: Covid-19 vaccines: Many ADRs are already expected

Dear Editor

The Ted-tenders electronic daily: Supplement to the Official Journal of the EU, details a contract negotiated by the Medicines and Healthcare Products Agency (MHRA), dated 14.9.20 (1).

It states: “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”.

It further explains: “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…… 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”.

Why do they expect that a high volume of ADRs will be generated?

And would it not be more sensible to determine the safety profile of a Covid-19 vaccine while the stable door is shut, rather than monitor the galloping horse once it has bolted?


Competing interests: No competing interests

11 November 2020
Janet Menage
GP retired
Wales, UK