FOI release

Freedom of Information request on the death's reported following the COVID-19 vaccines (FOI 21/1216)

Published 31 May 2022

FOI 21/1216

9th December 2021

Dear

Thank you for your email dated 17th November 2021 where you wished to clarify some of the information provided in FOI 21/941 with regards to permission to follow up. You also requested the following information under the Freedom of Information (FOI) act:

• How many deaths did you actually get permission to follow up?

• How many of the large amount of deaths reported on that system for COVID vaccines have you bothered to follow up?

• Of those that you followed up, how many deaths did you decide were actually due to the vaccine?

• For how many deaths did you liaise with coroners to get to the truth of the cause of death?

• Of these deaths how many did you ensure were submitted to the ONS so they could be listed as deaths due to vaccine. How many of these deaths did you ensure were then entered into the Iris software for ICD 10 so that they could be coded as vaccine deaths? Specifically, from the COVID vaccines? If you could not enter this information yourself, or code it yourself, how many deaths did you pass on to relevant doctors or coroners to enter the death information correctly to the ICD 10 Iris software?

Firstly, I would like to confirm that the information provided to you in FOI 21/941 was correct regarding permission to follow up adverse drug reaction reports and I apologise for any confusion caused. We ask for the reporter’s name and contact details so that we can get in touch if we need more information on their case. This information is outlined in our Privacy Policy which can be viewed via this link Yellow Card Scheme - MHRA. The Privacy Policy for the coronavirus Yellow Card reporting site, needs to be accepted before the user can submit their report. Therefore, the MHRA does not need to seek permission to follow up once a report has been submitted.

As you aware, the MHRA is responsible for monitoring the COVID-19 vaccines on an ongoing basis to ensure their benefits continue to outweigh any risks. This is a requirement for all authorised medicines and vaccines in the UK. This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected rare events. All reports with a fatal outcome are fully and continuously evaluated by the MHRA. We publish a weekly summary of Yellow Card reporting which summarises information received via the Yellow Card scheme and includes events with a fatal outcome. This summary specifies the number of reports in which the patient died shortly after vaccination for each COVID-19 vaccine and is updated on a weekly basis.

When reviewing all of the data received via the Yellow Card Scheme, it is important to note that just because a Yellow Card has been submitted reporting a suspected adverse reaction to the vaccine, it does not necessarily mean that the vaccine caused the reaction. Vaccination and surveillance of large populations means that, by chance, some people will experience and report a new illness or events (including events with a fatal outcome) in the days and weeks after vaccination. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

The MHRA takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously and every report with a fatal outcome is fully evaluated and kept under continual review. Follow-up is an important part of this assessment, where there is no post-mortem or certified cause of death the MHRA will endeavour to follow up the report. However, It is also important to note that not all reports may be suitable for follow-up for a number of reasons, including, a report in itself may already be complete including post-mortem, follow-up may be spontaneously received or at the time of reporting a reporter may state that they have no further information.

Each time new information is received for a report, it is reassessed to consider whether the vaccine may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. Additional data sources are also analysed to aid this assessment including data from trials, observational studies and other international regulators. This information is further considered by the Commission on Human Medicine and its Expert Advisory Groups.

Further to your request regarding how many reports with a fatal outcome have been followed up by the MHRA, we would need to manually review each case on our system to determine if a request for further information has been sent. Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. We consider the review of all fatal reports to determine if requests for further information have been sent will take longer than 24 working hours to complete.

In answer to your third question above, reports received via the Yellow Card Scheme are spontaneous suspected adverse reactions, therefore the reporter only requires a suspicion that the vaccine caused the adverse event. Whilst we evaluate every report, we do not assign each fatal report a category to determine if the death was caused by the vaccine.

As you may be aware, reports of adverse reactions to the COVID-19 vaccinations to the Yellow Card Scheme can be reported by anyone, including Coroners. The MHRA may also receive reports from Coroners directly via a Coroners Regulation 28 report to prevent future deaths, in these cases the MHRA has a duty to respond to any concerns raised by the Coroner within 56 days. However, it is not mandatory for a Coroner to notify the MHRA if they become aware of a death where a COVID-19 vaccination is cited. Where a report has been received by a Coroner or we have additional contact details of the Coroner, the MHRA can contact them for further information.

Part of the MHRA’s continual review of reports with a fatal outcome includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. This review uses data from the Office for National Statistics (ONS) death registrations, however, the MHRA has no statutory requirement to report suspected fatal reports due to the vaccine to the ONS. Therefore, the MHRA does not have responsibility for entering cause of death into the Iris software for ICD 10.

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: info@mhra.gov.uk. Please remember to quote the reference number above in any future communications.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division