FOI release

Freedom of Information request on testing coeliacs in the clinical trials for the COVID-19 vaccine (FOI 22/379)

Published 31 May 2022

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-14-february-2022/freedom-of-information-request-on-testing-coeliacs-in-the-clinical-trials-for-the-covid-19-vaccine-foi-22379

FOI 22/379

14th February 2022

Dear

Thank you for your email of 26th January where you have asked “Wondered if you could please help me find some information on how many coeliacs were tested in the clinical trials for the covid Pfizer vaccine, under the freedom of information please?

The Public Assessment Reports (PARs) published by MHRA and the EMA have details of the comorbidities of recipients at baseline at the following links below:

https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fpublications%2Fregulatory-approval-of-pfizer-biontech-vaccine-for-covid-19&data=04%7C01%7CDavid.Darling%40mhra.gov.uk%7C26925e025d3e4e344b4108d9e5bbf61c%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637793417731058112%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=%2BogllXOnxQUBRLPVjjOF5x8MZU%2FmwmE6%2FAs%2BnQPTfRI%3D&reserved=0

https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fcomirnaty&data=04%7C01%7CDavid.Darling%40mhra.gov.uk%7C26925e025d3e4e344b4108d9e5bbf61c%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C637793417731058112%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=7sb3CFxKsAooqjhh%2BvDbgtfrLkf3H8qEVztuG0Y5VEo%3D&reserved=0

Please note that coeliac disease is a condition where your immune system attacks your own tissues when you eat gluten https://www.nhs.uk/conditions/coeliac-disease/ . The Pfizer vaccine does not contain gluten and it is of course given as an injection rather than something which is eaten.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

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