Freedom of Information request on Covid Vaccines, Stage 3 results and MS (FOI 20-580)
Published 24 March 2021
© Crown copyright 2021
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-11-january-2021/freedom-of-information-request-on-covid-vaccines-stage-3-results-and-ms-foi-20-580
Thank you for your email.
MHRA has published information on the populations that have received the vaccine in the clinical trials, including any illnesses and medication they were receiving, and any adverse events experienced since receiving the vaccine. This information is available in the Public Assessment Reports (PARs) for the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, which are accessible via the relevant links below. https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
Additionally, the study results from the Pfizer/BioNTech vaccine (including the patients populations and any adverse events experienced) are available in a peer-reviewed journal, the New England Journal of Medicine. A link to this is provided below: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home
Based on the data received, advice has been given for use of the vaccines in individual patient groups in the Information for Healthcare Practitioners and Information for Recipients of the Vaccine. The Information for Healthcare Practitioners and Information for Recipients of the Vaccine for the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines can be accessed via the below links: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 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
There is no specific precaution or contraindication on the use of any of the authorised vaccines in patients with multiple sclerosis (MS). The vaccine is safe to administer to patients with MS and patients on immunosuppressants. The only relevant precaution in the Information for Healthcare Practitioners states “Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. No data are available about concomitant use of immunosuppressants.”
If you have a query about the information provided, please reply to this email.
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 you receive this response and addressed to: info@mhra.gov.uk
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 Service Centre Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000