Freedom of Information request on the yellow card reports following the COVID-19 vaccine (FOI 22/438)
Published 31 May 2022
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FOI 22/438
15th February 2022
Dear
Thank you for your email to the MHRA on 25 January concerning a contract award notice for an Artificial Intelligence (AI) software tool.
As background, the MHRA is responsible for monitoring the safety of all medicines and vaccines as well as medical devices and other healthcare products in the UK. The Yellow Card scheme is the UK system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices. The scheme is run by the MHRA and currently relies on voluntary reporting of suspected adverse drug reactions (ADRs) by health professionals and patients. The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices available on the UK market.
The safety of the public will always come first. With any major new vaccination campaign, we always develop a proactive vigilance strategy, and COVID-19 vaccines are no exception. Like all medicines, vaccines can cause side effects. Most are mild and short-term, and not everyone gets them. Some side effects can come to light when used by a larger number of people than took part in clinical trials.
It is important to note that a report of a suspected side effect is not proof that the vaccine caused the symptoms but a suspicion by the reporter that the vaccine may have caused the side effect. We have a range of resources and technology to support the proactive vigilance of the COVID-19 vaccination programme. The use of AI is one element of that. We take every report of a suspected side effect seriously and we combine the review of these individual reports with statistical analysis of anonymised clinical records. This specific AI tool is used for the surveillance of COVID-19 vaccines due to the potential size and scale of the vaccination campaign. The AI tool we have introduced helps 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 from the reporter is well structured to support analysis and subject to robust quality assessment.
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