FOI release

Freedom of Information request on the yellow card reports from the COVID-19 vaccines (FOI 21/958)

Published 17 January 2022

16th September 2021

FOI 21/958

Dear

Thank you for your email on 19th August where you requested the following:

1) Please can you publish the age groups of those who have been reported within events with a fatal outcome by each vaccine.

This is a separate request to you publishing iDAPs for each Covid vaccine. There is no reason to delay releasing this information as you already publish context, and have the ability to regularly update the age groups of “Table 5: Number of UK suspected thrombo-embolic events with concurrent thrombocytopenia ADR reports received for the COVID-19 Vaccine AstraZeneca by patient age up to and including 11 August 2021.”

2) Please specify the process of how MHRA is able to update the age groups in “Table 5: Number of UK suspected thrombo-embolic events with concurrent thrombocytopenia ADR reports received for the COVID-19 Vaccine AstraZeneca by patient age up to and including 11 August 2021.”

3) Please confirm whether MHRA has an internal iDAPS for each Covid vaccine.

4) Please specify how exactly the yellow card reports for Covid vaccines differ to yellow card reports for all other drugs.

5) What was the process previously used to transfer DAPs to iDAPS.

Question 1

As stated in response to FOI 21/549, we consider that the data you have requested, a breakdown of patient ages in those reports with a fatal outcome, is exempt under Section 22 of the Freedom of Information Act (information intended for future publication). As previously explained, Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld however wish to publish this information alongside appropriate context and assessment.

As previously stated, it remains our intention to seek permission to publish interactive drug analysis prints (iDAPs) for vaccines which would enable stratification of the data by a number of factors, including age and fatal outcome. However, details of the deliberations on this matter are withheld under Section 35 of the FOI Act. Deliberations over whether to provide an age breakdown for reports with a fatal outcome, similar to Table 5 with the weekly summary are also exempt under Section 35. Section 35 protects the internal deliberative process as it relates to Government policy making. In other words, the exemption is intended to ensure that the possibility of public exposure does not deter from full, candid and proper deliberation of policy formulation and development, including the exploration of all options and the keeping of detailed records.

Question 2

Table 5 within the weekly summary is based on information held within the MHRA’s Yellow Card database that is extracted and updated each week.

Question 3

I can confirm that the MHRA does not hold internal iDAPs for any medicine or vaccine. As stated previously, the MHRA is awaiting approval to publish iDAPs for the COVID-19 vaccines and will provide a link to these when they become available.

Question 4

Reports of suspected adverse drug reactions can be submitted to the MHRA in a number of ways and depending on the route and information provided, different questions may be asked of the reporter. In addition to the MHRA’s Yellow Card website and mobile phone app, we have developed the Yellow Card Coronavirus website and app. This has allowed us to tailor the questions for reports of the COVID-19 vaccines as new information about coronavirus has become available through the pandemic, without affecting the reporting form for all other medicines and vaccines. The type of information collected through all of these routes is however, largely the same and focuses on the medicine or vaccine, suspected adverse reactions, past medical history and concomitant medications.

The MHRA publishes a more comprehsive analysis of reports associated with the COVID-19 vaccines at more regular intervals as it is in the public interest to do so.

Question 5

I can confirm that DAPs and iDAPs are independent of one another. As iDAPs are not produced from DAPs, therefore the MHRA does not hold this information.

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 this response’s date and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division