FOI release

Freedom of Information request (FOI 22/958)

Published 17 January 2024

13th October 2022

FOI 22/958

Dear

Thank you for your email dated 6th October 2022, please accept our apologies for misinterpreting your initial request. We had originally interpretated your request to be for the number of reports specifically reported from healthcare professionals. Further to your email and clarification of your request we have provided you with updated data and information.

Up to and including 11th October 2022, MHRA has received a total of 35 spontaneous suspected Adverse Drug Reaction (ADR) reports directly from healthcare professionals and members of the public following COVID-19 vaccines stating the ‘GX11 1AA’ postcode. Table 1 below shows a breakdown of these 35 reports by the brand of COVID-19 vaccine as well as the number of reactions provided within these reports. Please note that a single ADR report may contain more than one adverse drug reaction.

The MHRA has not received any suspected ADR reports for vaccines/immunisations other than COVID-19 vaccines from Gibraltar GX11 1AA.

Table 1: Total number of spontaneous suspected ADR reports received from Gibraltar (GX11

1AA) following COVID-19 vaccines.

Vaccine	Number of suspected ADR reports	Number of reactions
COVID-19 Pfizer/BioNTech Vaccine	33	109
COVID-19 Vaccine AstraZeneca	2	2
COVID-19 Vaccine Moderna	0	0
COVID-19 vaccine brand not
specified	0	0
Total	35	111

Please be aware that the above figures have been extracted based on the reporters’ postal code. Hence, the accuracy of this data relies on the postcode being correctly provided in the original Yellow Card. Please also note that it is not mandatory to provide a postal address when submitting a Yellow Card to the MHRA. Therefore, if the postcode is not provided or if the reporter has only provided their email address, the report will not be included in these data. With this in mind, the data provided may not reflect the true incidence of reporting to the MHRA following COVID-19 vaccination reported from Gibraltar.

In addition to the above, please find attached the Vaccine Analysis Print (VAP) for Pfizer/BioNTech COVID-19 Vaccine for the reports noted in table 1. Please refer to the attached information sheet for guidelines on how to interpret the VAP.

When viewing the vaccine analysis print you should remember that:

• Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine or vaccine may have caused the adverse reaction. The existence of an adverse reaction report in the print does not necessarily mean that the vaccine has caused the suspected reaction.

• It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.

• Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.

The two reports for the COVID-19 AstraZeneca vaccine are the same reports as described in the previous FOI response (FOI 21/1053).

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,

Vigilance and Risk Management of Medicines Division