FOI release

Freedom of Information request on data included in the summary of Yellow Card reporting on suspected reactions to COVID-19 vaccines (FOI 22/017)

Published 1 June 2022

FOI 22/017

March 31st 2022

Dear

Thank you for your email on 2nd January, where you asked questions relating to data included in the summary of Yellow Card reporting on suspected reactions to COVID-19 vaccines. Please note, in our response below, we have grouped questions one and two together as they share the same response from the MHRA.

1. From the Yellow Card report published on 20/12/2021, it was confirmed that 1,889 adverse events with a fatal event and 411,594 adverse drug reaction reports have been reported. Can the MHRA please provide the following information:

• i i) Age bands of the 411,594 patients that have submitted reports (in 5 year or 10 year bands if this is available)
• ii ii) Age bands of the 1,889 patients that have died (in 5 year or 10 year bands if this is available)
• iii iii) The number and/or percentage of the 1,889 fatal event yellow cards that are submitted by Medical Professionals or Healthcare Professionals
• iv iv) The number and/or percentage of the 411,594 yellow cards that are submitted by Medical Professionals or Healthcare Professionals

It should be noted that this information is provided by the European Medicines Agency (EudraVigilance system https://dap.ema.europa.eu/analytics/saw.dll?PortalPagesand ), also the United States of America VAERS system.

As you are aware, the MHRA previously confirmed in response to FOI 21/894 that we will publish interactive Drug Analysis Profiles (iDAPs) for the COVID-19 vaccines, and as such, this information remains withheld under Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure. 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 that there is strong interest in this data but consider that it is in the public interest to continue to uphold the Section 22 exemption at this time. This decision involved balancing the public interest in publishing the data now, with the public interest in publishing it at a later date.

The MHRA will be developing a more appropriate route to publication in Summer 2022 and subsequently begin implementing new systems for provision of data across all medical products including vaccines, enabling the MHRA to produce an improved and more suitable format for publishing data in general. This will enable the COVID-19 data collected to be published in such a way as to minimise the risk of misuse and through providing context to the data and clear guidance around what is being presented. This will allow us to mitigate risks we have identified such as undermining the wider Government public health campaign for widespread COVID-19 vaccination and the subsequent risk to public health and safety. Data will be available in the new format by the end of 2022.

1. From the Yellow Card report published on 20/12/2021, it was confirmed that 411,594 adverse drug reaction reports have been submitted and 1,889 patients had died in the UK. Can the MHRA please provide the following information:

• i i) Of the 1,889 patients that have died, how many of those deaths occurred in Scotland
• ii ii) Of the 411,594 yellow card reports submitted, how many of them were submitted from Scotland

Since your email on 2nd January 2022, the MHRA has updated the summary report on COVID-19 vaccines to include data from more recent Yellow Cards submitted up to and including 9th March 2022. It is important to note that the total number of reports received cannot be calculated by the sum of the number of reports per vaccine stated in the weekly summary, as one report may refer to more than one vaccine.

Further to your request, please see below the breakdown of the number of spontaneous suspected adverse drug reaction (ADR) reports received from Scotland for each vaccine used in the UK’s COVID-19 vaccination programme up to and including 9th March 2022. Please be aware that the data included in this response has been extracted based on reporter postal code; therefore, the accuracy of this data relies on the postcode being correctly provided in the original Yellow Card. It is also important to note that the provision of a postal address is not a requirement to submit a report; therefore, this information is not always provided. With this in mind, the data provided may not reflect the true incidence of reporting following COVID-19 vaccination from Scotland.

Table 1: Total number of spontaneous suspected ADR reports and the total number of reports with a fatal outcome from Scotland up to and including 9th March 2022. Brand of COVID-19 vaccine:

Table 1: Total number of spontaneous suspected ADR reports and the total number of reports with a fatal outcome from Scotland up to and including 9th March 2022. Brand of COVID-19 vaccine	Total number of ADR reports	Total number of fatal reports
COVID-19 Vaccine AstraZeneca	17,420	103
COVID-19 Vaccine Moderna	3158	4
COVID-19 Pfizer/BioNTech Vaccine	12,616	54
COVID-19 Vaccine – Brand unspecified	161	6

For the reasons mentioned above, the sum of the number of reports in Table 1 will not equate to the incidence of Yellow Card reporting from Scotland. The figures provided in Table 1 is per vaccine brand, and one Yellow Card can include more than one COVID-19 vaccine brand.

Reports of fatal events are being monitored closely and are extensively evaluated by the MHRA. As with any serious suspected ADR, fatal cases are carefully followed up to gather relevant information when the reporter has provided permission. Vaccination and surveillance of large populations mean that, by chance, some people will experience and report a new illness or events in the days and weeks after vaccination. We carefully review reports to distinguish possible side effects from illnesses that would have occurred irrespective of vaccination. Coincidental adverse events are more likely to occur in elderly patients or people with underlying illnesses, and these two groups represent the patients in most of the fatal reports received. Reviews of specific fatal reports, such as thrombo-embolic events with concurrent low platelets, are provided in the weekly summary here. The pattern of reporting for other fatal reports does not suggest the vaccines played a role in these deaths.

In addition to the table provided, please find enclosed Vaccine Analysis Prints (VAPs), which list all spontaneously reported, suspected reactions, including fatal reactions, for the COVID-19 vaccines AstraZeneca, Moderna and Pfizer/BioNTech up to and including 9th March 2022. There is also a VAP for ADR reports where the brand of the COVID-19 vaccine is unspecified. Please note the ADR data for the COVID-19 vaccines AstraZeneca and Pfizer/BioNTech had to be split into two VAPs due to a technological limitation extracting this data from our ADR database. The ADR data is separated according to the date the report was received. Please refer to the attached information sheet for guidelines on how to interpret the prints.

When considering the spontaneous ADR data detailed above, it is important to be aware of the following points:

• • • A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccines. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• • • It is also important to note that Yellow Card data cannot be used to determine the incidence of a reaction or to compare the side effect profiles of different medicines or vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug or vaccine and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines or vaccines during the first one to two years on the market and then falls over time.

As this data does not necessarily refer to proven side effects, you should refer to the product information (Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)) for details on the possible side effects of each COVID-19 vaccine, which can be found on the Yellow Card coronavirus website here.