FOI release

Freedom of Information on the reactions and deaths and following up to ascertain if these were due to vaccine administration or other reasons (FOI 22/227)

Published 1 June 2022

FOI 22/227

14th February 2022

Dear

– COVID-19 Vaccine Yellow Card Reports

Thank you for your FOI follow up request dated 15th February 2022 in response to FOI 21/1225, where you have requested the following information:

1. Who is looking into the reactions and deaths and following up to ascertain if these were due to vaccine administration or other reasons?

2. How many of those deaths or severe adverse reactions received payment under the COVID 19 vaccines [https://www.gov.uk/vaccine-damage-payment/eligibility?](https://www.gov.uk/vaccine-damage-payment/eligibility

3. Please can you confirm that 85 percent of incidents reported on the yellow card are reported by health care professionals?

4. Can you confirm that these reports submitted are thoroughly checked to ensure they are authentic?

5. Can you confirm that the yellow card reporting only captures around 10 percent of all adverse reactions and deaths?

6. Once again can you confirm that these reports are accurate reports?

With regards to your first, fourth, and sixth questions, and to provide some further background on the Yellow Card scheme, we collect the Yellow Cards and enter them onto a specialised database that allows us to process and analyse the reports rapidly. We evaluate the reports concerning COVID-19 vaccines on a twice weekly basis in order to identify previously unidentified potential hazards, and new information on recognised side effects. On the very rare occasion, when a report is assessed and confirmed to be inauthentic, it would not be committed to our database.

After entry onto the database, Yellow Card reports are assessed by a team of physicians, pharmacists and scientists, with expertise in assessing the benefits and risks of medicines. Importantly, at this stage we also use other data sources to investigate the causal relationship between the medicines and reported reactions and to identify possible risk factors e.g. age, underlying disease and genetic predisposition. These sources include, for example, case reports in the literature, information from pharmaceutical companies, pre- and post-marketing clinical trials, epidemiological studies and data from other medicine regulatory authorities and from global adverse drug reaction (ADR) databases.

Occasionally further information or clarification is requested from the reporter so that the report can be properly evaluated. The MHRA takes all reports of side effects with the utmost seriousness,

including those that sadly report a fatal outcome. To ensure the comprehensive assessment of fatal reports, we follow-up all fatalities where permission has been provided, for further information including details of any post-mortem findings.

Regarding question two, as the MHRA and the Yellow Card scheme has no relationship to the Vaccine Damage Payment Scheme, we cannot comment on this. Therefore if you require more information, the relevant contacts can be found here: https://www.gov.uk/vaccine-damage-payment/how-to-claim.

Concerning your third question, up to and including 6th March 2022, on average 16% of the Yellow Card reports concerning the COVID-19 vaccinations currently in use in the UK (Oxford-AstraZeneca, Pfizer-BioNTech, Moderna and Janssen) were submitted by healthcare professionals (HCPs). However, please note that all HCPs who received the vaccine and submitted a Yellow Card on behalf of themselves would be classed as patients on our system.

When considering spontaneous data, it is important to be aware of the following:

• A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines.

• All reports are kept under continual review in order to identify possible new risks. For a medicine or vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people take medicines and vaccines without having any serious side effects.

With regards to question 5, the reporting rate for spontaneous ADRs is variable and can depend on a multitude of factors. Although some historical studies have estimated only 10% of ADRs are reported, the actual rate is unknown and will be influenced by public awareness and seriousness of the event. This figure should not be used as the reporting rate of ADRs for COVID-19 vaccines, for which there is high public awareness of the Yellow Card scheme and encouragement of reporting of all events. It should be noted that we take into account the variable levels of reporting across all medicines and vaccines as part of our monitoring procedures, using statistical techniques.

I hope that you will find this information useful.

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