Freedom of Information request on coeliac disease and COVID-19 vaccines (FOI 21/713)
Published 29 December 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-19-july-2021/freedom-of-information-request-on-coeliac-disease-and-covid-19-vaccines-foi-21713
19th July 2021
FOI 21/713
Dear
Thank you for your FOI request dated 24th June.
The demographics of the subjects who participated in each of the clinical studies is presented in the Public Assessment Report (PAR) for each vaccine, including any illnesses they presented with at inclusion into each study. Links to these are provided below:
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna
https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen
https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca
Unfortunately, no separate analysis of the efficacy or safety has been done specifically on any subjects with coeliac disease who may have been included in any of the studies.
Further advice is available on the Coeliac UK website, which states “Our Health Advisory Council, a group of expert healthcare professionals working in coeliac disease from across the UK, recommends that a diagnosis of coeliac disease does not increase the risk of side effects or complications after vaccination.” A link to this advice is available below:
Unfortunately, we are unable to provide details of past medical history for individual cases. Because of the way this information is captured within our database, this would require manual extraction of the information from each individual case. Therefore, this information is exempt from release under Section 12 of the FOI Act. Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. Please be reassured that any information provided regarding a patient’s past medical history or concurrent conditions is taken into account during the routine assessment of all cases that we receive. We can confirm that we are not aware of any robust evidence to suggest that people with coeliac disease are more at risk of adverse reactions than those without.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division