FOI release

Freedom of Information request (FOI 22/853)

Published 17 January 2024

FOI 22/853

26th August 2022

Dear

Thank you for your further email and information request, dated 28 July 2022 where you asked

1. For a list of the potential signals that you have examined for the AZ vaccine with a summary result

2. What the criteria is for examining for a signal?

3. Any clinically related summary documents relating to why the AZ vaccine is being withdrawn from use?

With regard to your first question, as of 27 July 2022, for the UK, 245,996 Yellow Card reports have been reported for the AstraZeneca COVID-19 Vaccine. Therefore, as advised previously in our response to you of 27 July regarding your FOI request FOI 22/791, although we hold information on all signal reviews for the AstraZeneca COVID-19 vaccine, the request for information within your correspondence would fall under Section 12 of the FOI Act. Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with the request 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. If you could refine your request by choosing a specific time period or particular adverse drug reaction that you are interested in, we will reconsider the request.

In answer to your second question about the criteria for examining a signal, many factors are considered. Yellow Card reports of suspected adverse drug reactions are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern. In particular, all reports of events with a fatal outcome are carefully reviewed to distinguish possible side effects from illness that would have occurred irrespective of vaccination. These reports are reports are also followed up for further information. In addition, part of our continuous analysis 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.

We supplement this form of safety monitoring with other epidemiology studies including analysis of data on national vaccine usage, anonymised GP-based electronic healthcare records and other healthcare data to proactively monitor safety. These combined safety data enables the MHRA to detect side effects or safety issues associated with COVID-19 vaccines.

Finally, in relation to your third question, COVID-19 vaccine AstraZeneca remains authorised in the UK. Information on the regulatory approval of COVID-19 vaccine AstraZeneca is available at https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca.The Joint Committee on Vaccination and Immunisation (JCVI) advises UK health departments on immunisation including recommendations on deployment of individual COVID-19 vaccines in the UK. JCVI advice is independent of MHRA.

If you have a query about the information provided, please reply to this email.

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 you receive this response and addressed to: info@mhra.gov.uk.

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 FOI Team,

Safety and Surveillance