Freedom of Information request on a list of the quantitative scientific analyses that have been conducted to date that utilise data collected in the Yellow Card database of COVID-19 vaccine adverse events.(FOI 21/1102)
Published 26 May 2022
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FOI 21/1102
16th November 2021
Dear,
Thank you for your email dated 27 September where you request a review of the MHRA response to your Freedom of Information (FOI) request FOI 21/923.
Within FOI 21/923 you requested a list of the quantitative scientific analyses that have been conducted to date that utilise data collected in the Yellow Card database of COVID-19 vaccine adverse events. For each of these analyses provide a title for the report, the name of the agency or corporation making the report, and a copy of, or link to the report in which these analyses can be found. This request was considered exempt under Section 12 of the FOI act due to the time it would take to retrieve and review this information.
Within your follow-up email dated 27 September, you requested one scientific report for each of the following five adverse events: thrombo-embolic events with concurrent low platelets, capillary leak syndrome, menstrual disorders, myocarditis and pericarditis and Guillain-Barre syndrome. If there exist no scientific reports that use the Yellow Card data to analyse these reported conditions, please reply by stating that no such scientific reports exist.
I can confirm that this new request has been logged under FOI 21/1102. Yellow Card reports of suspected Adverse Drug Reactions (ADRs) are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. To inform its decision-making, the MHRA also seeks independent expert advice from the Commission on Human Medicines (CHM). In May 2020, the CHM established an Expert Working Group (EWG), consisting of experts in medicine, infectious disease, pharmacoepidemiology and data analytics to provide the MHRA with independent oversight and advice on its COVID-19 vaccine vigilance activities. Scientific reports which summarise all available evidence on particular safety topics are regularly compiled and shared with this group for advice.
These scientific reports are withheld under Section 35 of the FOI Act as the MHRA has not yet reached its final regulatory position on any of the safety topics listed above. No definitive causal relationship between the COVID-19 vaccines and each of these events has been established, and therefore the MHRA’s assessment is ongoing taking in to account new evidence as we receive it. Section 35 of the FOI Act protects the internal deliberative process as it relates to government policy making.
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
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