FOI release

Freedom of Information request (FOI 22/1065)

Published 17 January 2024

24th November 2022

FOI 22/1065

Dear

Thank you for your Freedom of Information (FOI) requests dated 27th October 2022 where you requested the following:

1. Upon receipt of fatal COVID-19 AstraZeneca Vaccine reports can the MHRA request inquests into the cause of death? If yes, how many times has this happened?

2. The percentage of Yellow Card reports that are the subject of Coroners inquests?

3. How many Regulation 28, Report To prevent Further Deaths notifications have the MHRA received which included reference to the COVID-19 AstraZeneca vaccine?

4. Does the MHRA, upon receipt of a Regulation 28 notification in respect of COVID-19 AstraZeneca forward it /inform the manufacturer?

5. Does the MHRA provide responses within the 56-day deadline contained in the Regulation 28 notification and if so, are these published/accessible to the public?

The MHRA continuously monitors the post-marketing safety of vaccines through a variety of pharmacovigilance processes. All adverse reaction reports submitted by patients and healthcare professionals via the Yellow Card scheme or by pharmaceutical companies, are reviewed by our signal assessors to ensure all information provided by the reporter is accurately committed onto our database. Any relevant or missing information is quickly, and adequately followed-up with the reporter to obtain the full picture of the individuals medical history.

We follow-up all fatalities, where permission has been provided to do so, for further information, including post-mortem details if available. All details within a report are thoroughly assessed to consider whether the suspect drug or vaccine may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. Further to point 1 requested above, we cannot confirm the causality of the fatal event as this can only be determined by the coroner. It is also not within our remit to request an inquest into a particular fatality.

Regarding point 2 of your request as to the percentage of Yellow Card reports subject to coroner’s inquest; this is not a detail that the MHRA specifically requests and therefore cannot provide this. We encourage all patients and healthcare professionals to reports to the scheme, including coroners. However, I can confirm that we have received 34 fatal adverse reaction reports for all COVID-19 vaccines reported specifically by coroners.

Further to points 3 to 5 of your request, I can confirm that the MHRA have not received any Regulation 28 reports for any COVID-19 vaccine. The MHRA do respond to Regulation 28 notifications and the responses are published here: Reports to Prevent Future Deaths - Courts and Tribunals Judiciary. The MHRA may request a time extension from the coroner in order to fully investigate and seek expert advice from the appropriate expert advisory committee of the Commission on Human Medicines if required.

Additionally, the MHRA has a responsibility to inform pharmaceutical companies of any adverse reaction reports received by the MHRA, for medicines and vaccines that they hold a license for. The MHRA forwards on anonymised Yellow Card report details for Regulation 28 notifications, the same as it does for all other Yellow Card reports, this is covered in our privacy policy.

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