FOI release

Freedom of Information request (FOI 22/817)

Published 17 January 2024

8th August 2022

FOI 22/817

Dear

Thank you for your email follow up email dated 8th July 2022, where you asked for the following:

• An update to FOI Yellow Card adverse event data to FOI 22/040 please up to the current date for the Isle of Man, along with the relevant DAP attachments.

Further to your request, I can confirm up to and including 27th July 2022 the MHRA have received 1,025 direct spontaneous Adverse Drug Reaction (ADR) reports associated with a COVID-19 vaccine where the reporter provided a postcode registered within the Isle of Man (IM1 to IM9). 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 and therefore, this information is not always provided.

Table 1 below provides a breakdown of the number of reports that have been received for each of the COVID-19 vaccines. You will note that the total number of ADR reports in the table does not add up to the total provided above as one report may include more than one vaccine brand. Finally, where less than 5 reports have been received for a specific vaccine, an asterisk has been used to conceal this number in order to comply with data protection laws and protect patient/reporter confidentiality.

Table 1: Total number of UK spontaneous suspected ADR reports from the Isle of Man up to and including 27th July 2022.

Brand of COVID-19 Vaccine	Total number of reports
COVID-19 Vaccine AstraZeneca	627
COVID-19 Vaccine Moderna	92
COVID-19 Pfizer/BioNTech Vaccine	309
COVID-19 Vaccine brand unspecified	*

In addition to the table provided, please find enclosed Vaccine Analysis Prints (VAPs) which list all reported spontaneous suspected ADRs associated with the COVID-19 vaccines up to and including 27th July 2022 received from the Isle of Man. Three VAPs are provided, one each for the COVID-19 Pfizer/BioNTech vaccine, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna. Please refer to the attached information sheet for guidelines on how to interpret the prints.

When considering spontaneous ADR data, it is important to keep in mind 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 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 drug or vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. 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 or vaccine. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time. For these reasons the above data should not be used as a basis for determining incidence of side effects. During assessment we take into account of the variable levels of reporting as part of our monitoring procedures.

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 the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Safety and Surveillance

Medicines and Healthcare products Regulatory Agency