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S6W-05777: Dr. Sandesh Gulhane (Glasgow)

Scottish Conservative and Unionist Party

Date lodged: 20 January 2022

To ask the Scottish Government whether it is the case that the Medicines and Healthcare Products Regulatory Agency (MHRA) Yellow card system, including the Genpact UK artificial intelligence tool, is used to monitor and process COVID-19 vaccine adverse drug reactions occurring in Scotland and, if it is not the case, what monitoring system is in use.

Answered by: Humza Yousaf 28 January 2022

The safety of all vaccines and medicines is monitored by the Medicines and Healthcare products Regulatory Agency (MHRA) on a UK-wide basis. This includes reports from the Yellow Card Scheme which allows health professionals and patients across the UK to flag up suspected adverse reactions to any vaccine or medicine, as well as reports from worldwide use and on-going scientific evidence.

The MHRA has a range of resources and technology to support the safety monitoring of the COVID-19 vaccination programme. The use of artificial intelligence is one element of that and helps to reduce the amount of manual coding for each report to the Yellow Card Scheme on COVID-19 vaccines, thereby saving resource in processing cases and ensuring they are more rapidly available for scientific analysis. The tool is not used for assessment of data, but to help ensure that all information from reports is well structured to support analysis and is subject to robust quality assessment.

Concerns over the safety of vaccines are not taken lightly. Please be assured that the MHRA keep the safety of all vaccines under close and continual review, and would take appropriate regulatory action if new evidence emerged which called into question the safety of any vaccines currently in use in Scotland.