FOI release

Freedom of Information request (FOI 22/846)

Published 17 January 2024

FOI 22/846

19th August 2022

Dear

Thank you of your email dated 26th July where you requested information on the use of artificial intelligence (AI) in our Yellow Card system. Responses to each of your questions is provided below.

To being with it may be useful to give you some background to the work we have done in relation to AI. The MHRA awarded the AI contract in September 2020 and this was subsequently deployed in December 2020. As included in your email, this activity was aimed to support processing of suspected Adverse Drug Reactions (ADRs) to COVID-19 vaccines.

The AI tool has helped us by reducing the amount of manual coding for each report, thereby saving resource in processing cases and ensuring they are rapidly available for scientific analysis. The tool is not used for assessment of data, but to help ensure that all the information provided in narrative text from the reporter is well captured to support analysis and is subject to robust quality assessment.

1. How many, if any, of the Yellow Card scheme case reports recorded to date have definitively failed to qualify for processing using the Genpact AI software?

All Yellow Card reports relating to COVID-19 vaccines received via the Coronavirus Yellow Card reporting website and Yellow Card App are processed by the AI software. None have failed to qualify for processing using the Genpact AI software.

1. How many Yellow Card Scheme case reports recorded to date have been downloaded to the Genpact AI software to date?

Up to 31st July 2022 there are 424,180 Yellow Card reports which have been processed by the AI software.

1. How many of the Yellow Card Scheme case reports recorded to date have yet to be assessed for eligibility for inclusion in the Genpact AI software programme?

There are no Yellow Card reports awaiting assessment for eligibility for inclusion in AI processing.

1. How many of the case reports in question 2 involve non-fatal ADRs?

As mentioned above, there were 424,180 Yellow Card reports processed with AI up to 31st July 2022, 422,372 of these had a non-fatal outcome reported.

1. How many of the case reports in question 2 involve fatal ADRs?

As mentioned above, there were 424,180 Yellow Card reports processed with AI up to 31st July 2022, 1,808 had a fatal outcome reported.

1. When will an interim report be published detailing the numbers of case reports processed using the Genpact AI software tool?

The MHRA publishes details of all suspected reactions reported in association with available COVID-19 vaccines, along with our assessment of the data, in our summary of Yellow Card reporting. This includes those processed with support from the AI software.

No additional publication is planned.

1. When will an interim report be published giving comprehensive details of the scientific analysis to date of the cases at question 6?

As above, the MHRA publishes details of all suspected reactions reported in association with available COVID-19 vaccines, along with our assessment of the data, in our summary of Yellow Card reporting. This includes those processed with support from the AI software.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division