Freedom of Information request (FOI 22/794)
Published 17 January 2024
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FOI 22/794
22nd September 2022
Dear
Thank you for your letter outlining an FOI request in relation to your concerns about a temporal association between Scottish Excess Mortality data and COVID-19 vaccinations.
Apologies for the delay in responding to you.
You requested:
1) Any and all documents or minutes of meetings analysing the Scottish excess all-cause mortality data and the temporal associations with COVID-19 vaccinations
2) Any and all documents or minutes of meetings analysing the Scottish data regarding ambulance call-outs for cardiac events in young people and the temporal associations with COVID-19 vaccinations
The MHRA does not hold the data you request. You may wish to contact Public Health Scotland.
Please be assured that the MHRA has closely monitored the safety of the COVID-19 vaccines used across the UK since the first vaccine was administered in December 2020. We have in place a proactive strategy to do this. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.
Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when vaccines are being given to the most elderly people and people who have underlying illness. A number of detailed assessments of safety topics have been undertaken and we have updated our advice on these topics accordingly. Details of our safety assessments can be found in our publication on the safety of coronavirus vaccines here Coronavirus vaccine - summary of Yellow Card reporting - GOV.UK (www.gov.uk) This includes a section on reports with a fatal outcome which includes information from a study conducted by the Office for National Statistics which concluded that COVID-19 vaccines were not associated with an increased risk of death in the population studied.
Overall, our advice remains that the benefits of the vaccines outweigh the risks in the majority of people.
If you have a query about the information provided, please reply to this email.
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre