FOI release

Freedom of Information request (FOI 22/1005)

Published 17 January 2024

27th October 2022

FOI 22/1005

Dear

Thank you for your email dated 29 September 2022 where you asked for information concerning COVID-19 vaccines including Yellow Card processing, EBGM analysis, MaxSPRT analysis and under-reporting estimation and sensitivity analysis under the Freedom of Information (FOI) act.

Unfortunately, the majority of your FOI request falls 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 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. Some parts of your request we can provide to you and others fall under Section 40 (personal information) and Section 41 (information provided in confidence).

We therefore ask you to refine your request to fit within the appropriate FOI limits and so that we can provide with information we hold and that is releasable. Please see find explanations below for each of your questions which should help you refine your request appropriately.

1. Processing of Yellow Card reports

For the period between February 2021 and August 2022: a) How many Yellow Card reports relating to COVID-19 vaccines were received by MHRA and how many resulted in MHRA follow-up contacts to reporters?

Although we hold information on whether a Yellow Card report has been followed up, this information is not easily extractable. For the period between February 2021 and August 2022, the MHRA received over 427,000 Yellow Card reports associated with a COVID-19 vaccine. An individual would need to manually open each Yellow Card report to check whether a request for further information was sent. Checking a single Yellow Card report for evidence of follow up would take a minimum of 45 seconds and in some instances longer. This would equate to an individual spending over 5000 hours for this aspect of your request.

b) What are or were the criteria for making such a contact? Each report is assessed on a case-by-case basis to determine whether follow-up is required; the necessity for follow-up depends on several factors. The criteria used for seeking follow-up is held and can be released under a new refined FOI request.

c) What percentage of Yellow Card reports met the criteria?

d) For what percentage of cases that met the criteria have contacts been made?

If the criteria for follow-up contact changed between February 2021 and August 2022, please specify the various sets of criteria and the dates between which each set of criteria applied. In this case, please respond to each of the questions above for each period in as much detail as possible, in addition to aggregate numbers for the whole period.

As stated above, the decision on whether to follow-up is taken on a case-by-case basis. An individual would need to manually open each Yellow Card report to determine the percentage which met the criteria and subsequently the percentage of these reports where contact was made. Therefore, this part of your request falls under Section 12 of the FOIA, please keep this in mind when submitting a refined request.

e) Please also supply the total number of Yellow Card reports received, and the total number of follow up contacts for all products included in the Yellow Card scheme in the years 2019 and 2020.

Over 43,000 Yellow Card reports were submitted in 2019 and over 40,000 were submitted in 2020. Please see response to question 1a, this also falls under Section 12 of the FOIA.

1. EBGM analysis

a) As an ongoing surveillance, this analysis should have been repeated at regular intervals as the data changed. Please state the regularity (eg daily, weekly, bi-weekly or monthly) at which this analysis was performed.

b) Please provide the specification or methodological procedure that MHRA used for the data processing and analysis used for EBGM signal detection.

The MHRA are able to provide this information under a refined request as this information is documented and easily extractable.

c) Please provide the input data used and the results of your EBGM analysis of Yellow Card reports for the COVID-19 vaccine program as they developed from February 2021 to August 2022, either:

• for each month during the period, or

• at the nearest interval to monthly at which the analysis was performed. For example, if the analysis was carried out bi-weekly, please provide the input data and analysis results at four-weekly intervals.

To calculate EBGM values for individual drug/vaccine-event combinations, all new Yellow Card reports are used (as “input data”) and all historic reports are used as background data in an observed vs expected model. We are unable to provide you with copies of individual Yellow Card reports as these are exempt from disclosure under Section 40 (personal information) and Section 41 (information provided in confidence) of the FOI act. Supplying you with this information could lead to patient identification. Further to the use of Section 40 and 41, as outlined in our Privacy Policy, the MHRA will not share the identity of anyone submitting a Yellow Card report with any person outside the MHRA without their explicit consent, unless we are required or permitted to do so by law. As this is personal data in relation to an individuals’ health, this would be of detriment to them and may damage the engagement with the scheme.

We do not hold information specifically for the assessment of individual EBGM values as we review the data and evidence as a whole. Results and the outcome of our assessments are all contained within the Summary of Yellow Card reporting which is currently published and updated monthly. .

1. MaxSPRT analysis

a) Please provide the expected counts or background rates of the classifications of adverse events that were used for your analysis, and details of the basis and derivation of these expected background counts in the UK population.

b) Please provide the input data and results of your MaxSPRT analysis from February 2021 when the referenced document was published to August 2022, either:

• for each month during the period, or

• at the nearest interval to monthly at which the analysis was performed. For example, if the analysis was carried out bi-weekly, please provide the input data and analysis results at four-weekly intervals.

The MHRA are able to provide details of the methodology employed to calculate background rates under a refined request. However, providing the expected counts or background rates of the classifications of all adverse events that were used for our analysis, as well as the input data and results of our MaxSPRT analysis from February 2021 to August 2022, would be exempt under Section 12 due to the number of separate analyses conducted in this time period.

1. Under-reporting estimation and sensitivity analysis

a) Please provide the range of under-reporting assumptions used in your analysis.

b) Please provide the procedure or algorithm by which the sensitivity analysis was carried out.

c) Please identify the MHRA’s “base case” assumption relating to under-reporting - i.e. what under-reporting factor is assumed by the MHRA to be most likely to reflect reality.

This information can be provided under a refined request.

We look forward to receiving your refined request taking into account the above information. I hope the information provided in order to help you refine your request 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. We look forward to receiving your refined request.

Yours sincerely,

FOI Team,

Safety and Surveillance Group