Freedom of Information request on the adverse reactions and death statistics relating to the COVID-19 vaccines (FOI 22/388)
Published 31 May 2022
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FOI 22/388
15th February 2022
Dear
Thank you for your email dated 19th January 2021, where you requested information relating to the COVID-19 vaccination and how fatal reports for the vaccine are classified.
Specifically relating to COVID-19 vaccinations, please could the MHRA or relevant body provide me with explanations as to how a death is determined to be caused by a vaccine, such as the Pfizer or AstraZeneca? i.e. what factors or parameters (please include all factors and parameters) determine such a death has been attributed to - or found to be caused by - a vaccine?
The Yellow Card scheme, which is run by the MHRA, is the UK program for collecting experiences of side effects from healthcare professionals and patients and is used to monitor the safety profile of all medicines, including those from prescriptions, over-the-counter or general retail sales. It is a voluntary scheme for healthcare professionals and members of the public; however there is a legal requirement for pharmaceutical companies to report side effects that they have received to the scheme.
The MHRA has been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at the population level. A summary of Yellow Card reporting relating to the COVID-19 vaccines is published each week and can be found here. The summary includes data analysis on reported suspected adverse reactions from the COVID-19 vaccines, including those with a fatal outcome.
Reports received via the Yellow Card scheme can be reported at any time after a suspected side effect has occurred. Additionally, the time frame from when the patient received the vaccine to experiencing a suspected side effect is not always provided by the reporter. We review and publish all Yellow Card reports, including those with a fatal outcome, regardless of the time to onset from receiving a medicine or vaccine.
Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine or vaccine may have caused the adverse reaction. The existence of an adverse reaction report on our database does not necessarily mean that the vaccine has caused the suspected reaction. For more information on how the MHRA monitors the safety of medicines and vaccines please see the following document.
It’s important to note that the MHRA only holds reports of suspected adverse drug reactions in relation to the COVID-19 vaccines associated with a fatal outcome and does not hold a comprehensive list of all deaths post vaccination. It is also not the role of the MHRA to determine the certified cause of death of the patient, this responsibility lies with the patient’s healthcare professional.
Specifically relating to COVID-19 vaccinations, please could the MHRA inform me as to whether or not there is a time period after a vaccine injection is administered when a death can be attributed to a vaccine? e.g. within 24 hours only. If there is a time period, could you please specify this. And what is the maximum length of time after an injection is administered that a death could be attributed to a vaccine?
When reviewing Yellow Card reports with a fatal outcome, there is no defined time period following vaccine injection when a death can or cannot be attributed to a vaccine. As stated above, reports received via the Yellow Card scheme can be reported at any time after a suspected side effect has occurred. Additionally, the time frame from when the patient received the vaccine to experiencing a suspected side effect is not always provided by the reporter. We review and publish all Yellow Card reports, including those with a fatal outcome, regardless of the time to onset from receiving a medicine or vaccine. When reviewing reports containing a fatal outcome, we consider all available evidence.
Please contact the Office for National Statistics (ONS) who are best placed to provide you with information regarding how a death is determined by a COVID-19 vaccine as this falls outside the remit of the MHRA.
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