FOI release

Freedom of Information request on recorded cases of temporal cell arteritis after receiving the COVID-19 vaccine (FOI 22/790)

Published 4 January 2024

FOI 22/790

26th July 2022

Dear

Thank you for your email dated 29th June 2022 where you requested information on recorded cases of temporal cell arteritis after people (especially females) received covid vaccines.

For background, it may be useful to know the MHRA has been continually monitoring the safety profile of COVID-19 vaccines licensed in the UK. This monitoring process involves the collection of information about suspected adverse reactions in patients (through the Yellow Card scheme) and assessment of any new suspicions of harmful effects. The Yellow Card scheme captures reports of suspected side effects from all users including patients and healthcare professionals alike. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects, and, if appropriate, regulatory action would be taken. This scheme is one way the MHRA carries out COVID-19 vaccine safety surveillance, and you can find out more information on our proactive pharmacovigilance strategy and how we monitor safety here.

Further to your request, I can confirm that the MHRA has received a total of 94 UK spontaneous suspected adverse drug reaction (ADR) reports associated with giant cell arteritis and COVID-19 vaccines (COVID-19 Vaccine BioNTech, COVID-19 Vaccine AstraZeneca, COVID-19 Vaccine Moderna, COVID-19 Vaccine brand unspecified) up to and including 19th July 2022. Of these 94 cases, 64 specifically reported female patients experiencing giant cell arteritis. Although there are a higher number of cases reporting female patients, it is important to note that there tends to be a female preponderance in spontaneous reports in general, so we would advise against drawing any conclusions on gender differences from this dataset. In terms of reporter types, 31 reports were submitted by healthcare professionals and 63 were submitted by patients.

Please see Table 1 below for a breakdown of the number of reports associated with giant cell arteritis for each COVID-19 vaccine.

Table 1: UK spontaneous suspected ADR reports associated with giant cell arteritis and COVID-19 vaccines (COVID-19 Vaccine BioNTech, COVID-19 Vaccine AstraZeneca, COVID-19 Vaccine Moderna, COVID-19 Vaccine brand unspecified) received up to and including 19th July 2022.

Brand of COVID-19 Vaccine	Number of suspected ADR reports	Number of suspected ADR reports in females
COVID-19 mRNA Vaccine Pfizer/BioNTech	24	14
COVID-19 Vaccine AstraZeneca	65	47
COVID-19 Vaccine Moderna	5	*
Brand unspecified	0	0

*Where less than 5 reports have been received for a specific COVID-19 vaccine in female patients, an asterisk has been used to conceal this number in order to comply with data protection laws and protect patient/reporter confidentiality.

It is important to note that the figures provided in Table 1 is per vaccine brand, and one Yellow Card can include more than one COVID-19 vaccine brand.

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

• Please note that reporters only have to provide one patient characteristic, such as age, sex, or weight, to successfully submit a Yellow Card report. Therefore, the patient’s sex is not always reported to the Yellow Card scheme. The data provided therefore only includes reports where the reporter has completed the field for patient sex as female and will not include reports with an unknown patient sex.

• A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the 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. Therefore, Yellow Card data cannot be used to determine the incidence of a reaction or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

The MHRA has been monitoring reports of autoimmune conditions following COVID-19 vaccination. There have also been some literature articles describing giant cell arteritis occurring in association with COVID-19 infection. However, no international regulatory agencies have identified an association between COVID-19 vaccinations and giant cell arteritis, including the MHRA, where there has been no signal detection for giant cell arteritis to date.

As you may be aware, further details on Yellow Cards reported in relation to COVID-19 vaccinations is available in our summary of Yellow Card reporting, which you can find here. You can find summaries of our assessment so far on particular safety topics surrounding the COVID-19 vaccinations, as well as some detail on patient demographics. In Annex 1, you will find four Vaccine Analysis Prints (VAPs). Each VAP lists all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for a COVID-19 vaccine up to and including 13th July 2022. Please consider the points mentioned above if you decide to review these VAPs.

As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://coronavirus-yellowcard.mhra.gov.uk/productinformation for details on the possible side effects of the COVID-19 vaccines.

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