FOI release

Freedom of Information request on deaths following COVID-19 vaccination in Northern Ireland (FOI 21/720)

Published 29 December 2021

26th July 2021

FOI 21/720

Dear

Thank you for your email dated 25th June 2021, where you requested the number of deaths following the COVID-19 vaccinations in Northern Ireland. Specifically, you requested details of the age, sex, location of vaccine, date of vaccine, date of death and cause of death. You also requested whether any adverse reactions have been reported in Northern Ireland in association with the COVID-19 vaccines, and if so, how many, which vaccine, age group and what reactions were reported.

When considering the data within this response, please consider the following:

• 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 does not necessarily mean that the vaccine has caused the suspected reaction.
• It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.
• Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.
• It is also important to note that the number of reports received does not directly equate to the number of people who may have experienced adverse reactions and therefore cannot be used to determine the incidence of reactions. ADR reporting rates are influenced by many aspects, including the extent of use.

The MHRA has been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at the population level. As requested, the MHRA has received 27 reports of suspected ADRs resulting in a fatal outcome from Northern Ireland up to and including 14th July 2021. As this figure is based upon the postcode provided by the reporter, it will only include reports where the reporter has provided the postcode. Please note that postcode is a mandatory field on the Coronavirus Yellow Card reporting site and therefore it is likely this information captures the majority of reports received for your specific request. Please note that reports received via other routes where postcode is not provided or where it is provided incorrectly are evaluated in the same way as all other reports received via the Yellow Card scheme. Review of individual reports and patterns of reporting does not suggest the vaccines played a role in these deaths.

With regards to your request for a detailed breakdown of fatal reports from Northern Ireland following the COVID-19 vaccination, this information is due to published in the near future. As such, we have determined that this information is exempt under Section 22 of the of the Freedom of Information Act. Section 22 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from publishing a detailed breakdown of fatal cases. However, we consider that the public interest will be better served by releasing the information when it is in its complete form, rather than the Agency releasing an incomplete version of the data prematurely.

You also asked whether there have been any adverse reactions reported in Northern Ireland in association with the COVID-19 vaccines, and if so, how many, which vaccine, age group, what reactions were reported. Please may I direct you to Table 3 within our weekly summary of Yellow Card reporting concerning the COVID-19 vaccines. Table 3 shows the number of suspected ADR reports received in the UK up to and including 14 July 2021 broken down by country and brand of vaccine. Details of reactions reported can be found in the accompanying vaccine analysis prints. Regarding the age group of the patients involved, I can confirm this information is exempt from disclosure under Section 22 of the Freedom of Information Act for the reasons detailed above.

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