Freedom of Information request on the the number of ADR's from specific geographic locations (FOI 21-780)
Published 27 April 2022
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2nd August 2021 FOI 21/780
Dear
Thank you for your email in response to your previous request (FOI 21/626). I can confirm that when submitting a Yellow Card report, the reporter has the option to supply their postcode therefore we collect data regarding geographical location when provided by the reporter. This information is currently not readily accessible online but can be provided by the MHRA on request. Due to the nature of the information and its input, this would require additional manual review of the information contained within each case to ensure postcodes are correct and then mapped to regions. However, as stated in our response to FOI 21/626, we consider that extracting this information, carrying out the additional review and mapping will take longer than 24 working hours to complete and therefore ask you to refine your request. To refine your original request, please provide the specific area or postcodes you would be interested in so we can provide a breakdown of the number of Adverse Drug Reaction (ADR) reports received from that specific location. It is important to note that the address including postcodes are required when using the COVID online reporting platforms but are not mandatory fields within the Yellow Card form and are therefore not always provided by the reporter. Furthermore, if the postcode is incorrectly provided, the Yellow Card will not be included in this analysis. The MHRA is using Artificial Intelligence (AI) software as a tool to optimise the process of our pharmacovigilance activities given the high volume of ADR reports received since the launch of the COVID-19 vaccination campaign, by efficiently capturing additional adverse drug reaction information. The tool is not being used for reporter information such as reporter addresses, but to help ensure that all clinical information from the reporter is well structured to support analysis. We are unable to provide an exact date as to when iDAPs for vaccines will be published. We recognise that there is strong interest in seeing this data and accept it should not be withheld indefinitely. Please be assured that we will send you the link to these as soon as they are available. I can confirm at this stage, geographic areas will not be searchable using iDAPs, however this is an area of development that the agency is exploring as part of future work. In the meantime, you may wish to view an updated version of the COVID-19 vaccines summary of Yellow Card reportingalongside the Vaccine Analysis Prints which contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for COVID-19 vaccines. As you are aware, Table 3 provides the number of suspected ADR reports received in the UK broken down by country and COVID-19 vaccine. When considering spontaneous data, it is important to be aware of the following points: • A reported reaction does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, and may be stimulated by promotion and publicity. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
The MHRA’s role is to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this. As part of this monitoring we consider trends in batch number being reported. Please note we have not identified any trends in ADRs associated with batch number and plan to publish this in due course. I hope the information provided allows you to refine your request so that we can provide you with the number of ADR reports for the locations you are interested in. 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