FOI release

Freedom of Information request on Yellow Card reports from Gibraltar concerning COVID-19 vaccines (FOI 21/819)

Published 20 January 2022

17th August 2021

FOI 21/819

Dear

Thank you for your email dated 17th July 2021, where you asked for information on the following:

1. “Please could you confirmed how many yellow card reports have been made from health care workers, allied health professionals , members of the public any medical organization from the start of the covid vaccination program from the Overseas Territory of Gibraltar?

2. How is yellow card report information promoted to health care providers delivering a tool and a method of procedure in the UK to ensure accurate methods of reporting and monitoring of vaccination to be correctly monitored with the regulatory authorities in charge of the regulation of these procedure and safety to the public ?”

The MHRA works closely with the UK devolved administrations as well as the governments of the British Overseas Territories. All individuals receiving a vaccine are encouraged to report side effects to COVID-19 vaccines to the Yellow Card Scheme by the local governments in these territories.

As per your request, up to 10th August 2021, I can confirm that we have received 22 Adverse Drug Reaction (ADR) reports associated with COVID-19 vaccines reported from Gibraltar. Please be aware that this information is based on ADR reports received directly from all healthcare professionals, patients, parents and carers. Please note, the information supplied is dependent on the accuracy of the data and relies on the postcode being provided as GX11 1AA by the reporter on the original Yellow Card. Furthermore, if the postcode is incorrectly provided or incomplete, the Yellow Card will not be included in this data.

You may find it useful to view the weekly summary of Yellow Card reporting which details the number of suspected ADR reports received in the UK per country. This can be found in Table 3 in the link below:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

When considering the spontaneous ADR data provided, it is important to be aware that 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 vaccines. All reports are kept under continual review in order to identify possible new risks.

In response to your questions about the Yellow Card and how it is promoted, the reporting of suspected ADRs is voluntary by healthcare professionals, however reporting is encouraged within the codes of practice of all healthcare professionals by their associations and regulators. We have in place a Yellow Card strategy that works to increase awareness, actively promote and make reporting to the scheme more accessible for everyone. Information leaflets provided at the time of vaccination or invitations to be vaccinated signpost individuals to the Coronavirus Yellow Card reporting site. In addition, we have run social media campaigns informing healthcare professionals and members of the public that reporting to the Coronavirus Yellow Card reporting site will enable the MHRA to rapidly identify new and emerging side effects. We have also issued a Drug Safety Update, a press release, and the general public have also been encouraged to report any suspected side effects to the vaccine to the MHRA via a Yellow Card on recent televised press briefings. More information about the Yellow Card scheme and the campaigns we have run can be found via the Yellow Card website. Since the launch of the national immunisation campaign the Yellow Card scheme has benefited from an increased spotlight and as such the MHRA has seen an increase in reports received for non COVID-19 related drugs and vaccines.

To maintain accuracy of the reports we receive, a team of scientific and medical assessors evaluate reports as part of our routine signal detection work where new ADRs or a change in frequency/characteristics of an ADR are identified when Yellow Card reports are entered onto our database and, if necessary are followed up for completeness and for further information as part of quality assurance. If appropriate, regulatory action would be taken if any serious risks were confirmed. Further information on how the MHRA monitors the safety of medicines and vaccines can be found here. Our AI (artificial intelligence) tool also optimises the process of our pharmacovigilance activities given the high volume of ADR reports since the launch of the COVID-19 vaccines, by efficiently capturing additional adverse drug reaction information to support analysis and quality assessment.

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