FOI release

Freedom of Information request (FOI 22/875)

Published 17 January 2024

FOI 22/875

2nd September

Dear

Thank you for your FOI request dated 7th August 2022 whereby you requested:

• All Yellow Card reports from COVID-19 vaccinations for Guernsey in the Channel Islands, broken down by Vaccine Manufacturer
• All Yellow Card reports from COVID-19 vaccinations for Jersey in the Channel Islands, broken down by Vaccine Manufacturer

As you may know, the MHRA works closely with the UK devolved administrations as well as the governments of the Channel Islands. All individuals receiving a vaccine are encouraged to report side effects to COVID-19 vaccines to the Yellow Card Scheme by the governments in these territories.

Following a search of our database up to and including 4th August 2022, I can confirm that the MHRA have received 399 spontaneous suspected Adverse Drug Reaction (ADR) reports associated with all COVID-19 vaccinations reported from Guernsey and 443 ADR reports reported from Jersey.

Once again, the data included within this FOI response has been extracted based on reporter postal code. It is therefore important to note that the accuracy of this data relies on the postcode correctly being provided by the reporter in the original Yellow Card. The provision of postal addresses is not required to submit a valid report; reporters are required only to provide a contactable address which can be either an email address or postal address. If reporters only provided an email address, these will not have been included in this analysis. As the data has been extracted using available postal addresses only, it may not reflect the true incidence of reporting following COVID-19 vaccination reported from Guernsey and Jersey. Please see Table 1 below for a breakdown of the number of reports received from Guernsey and Jersey for each COVID-19 vaccine. I would like to bring to your attention that if less than 5 reports have been received for a reported 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: UK Spontaneous suspected ADR reports received up to and including 4th August 2022, from Guernsey and Jersey in association with COVID-19 vaccines.

Reported vaccine	Number of suspected ADR reports from Guernsey	Number of suspected ADR reports from Jersey
COVID-19 Pfizer/BioNTech Vaccine	174	179
COVID-19 Vaccine AstraZeneca	182	237
COVID-19 Vaccine Moderna	40	21
Brand unspecified	*	7
Total	399	443

Further to your request, please find enclosed Vaccine Analysis Prints (VAPs) listing all the ADRs associated with the COVID-19 Pfizer/BioNTech Vaccine, COVID-19 Vaccine AstraZeneca and COVID-19 Vaccine Moderna from Guernsey and Jersey. A VAP guidance sheet is also enclosed which provides you with further information on how to interpret the print.

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

• A reported reaction does not necessarily mean it has been caused by the drug or vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug or 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 the variable levels of reporting as part of our monitoring procedures.

As previously mentioned, the Coronavirus vaccine – summary of Yellow Card reporting, is updated monthly and available here. This document may be of use to you as it contains details of all ADR reports pertaining to the COVID-19 vaccines received via the Yellow Card Scheme, as well as summaries of our assessment so far on particular safety topics surrounding the COVID-19 vaccinations, and some detail on patient demographics. Unfortunately, this data is not broken down by location, as per your request, but provides an overview of all reports received.

Please note that if you plan on sharing this data more widely, or publishing this data, please can you provide us with a copy prior to publication to ensure the correct interpretation and confidentiality of the data provided.

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