Freedom on Information request on adverse events of blood clots occurring with the COVID-19 vaccines (FOI 21-399)
Published 28 June 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-10-may-2021/freedom-on-information-request-on-adverse-events-of-blood-clots-occurring-with-the-covid-19-vaccines-foi-21-399
Thank you for your latest email dated 15th April 2021, where you requested information if any warnings were provided to politicians, NHS, and the general public regarding the adverse events of blood clots occurring with the COVID-19 vaccines.
The MHRA is the executive Agency of the Department of Health that acts on behalf of the Ministers to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment are used safely and meet appropriate standards of safety, quality, performance and effectiveness. The MHRA assesses the balance of risks and benefits of all medicines at the time of initial licensing and throughout their use in clinical practice. Where appropriate, the MHRA seeks advice from the independent Commission on Human Medicines (CHM).
The MHRA works in partnership across the healthcare system including with other government bodies (such as Public Health England), the NHS and directly with healthcare professionals, to ensure the safe use of medicines & vaccines. As a result of the COVID-19 pandemic, the MHRA has sought advice from the CHM in 2020 that established an Expert Working Group, consisting of experts from various fields, to provide the MHRA advice on its COVID-19 vaccine vigilance activities. More information on COVID-19 vaccine safety surveillance can be found here.
In relation to your query on the warnings of blood clots provided to the NHS, politicians and the wider public with the COVID-19 vaccine, a summary of Yellow Card reporting concerning the COVID-19 vaccines is published every Thursday and can be found here. The summary includes data analysis on reported suspected adverse reactions from the COVID-19 vaccines. Part of the report contains information of our review on blood clots. In reference to your comment on the ‘synthetic pathogen’, I would like to direct you to the Public assessment report for COVID-19 University Oxford/AstraZeneca. This report regarding the COVID-19 vaccine shows that the vaccine has a positive benefit/risk and are effective in preventing deaths, hospitalisations and the spread of COVID-19. We do not agree that any COVID-19 vaccines are experimental as they have been thoroughly assessed by MHRA, with no stages in the vaccine development processes bypassed.
Public Health England is also regularly updating and reviewing information and guidance for healthcare professionals on the very rare condition involving blood clots and unusual bleeding after COVID-19 vaccination. More information can be found here.
With regards to your concerns of whether Patient Information Leaflets (PILs) are given to patients receiving COVID-19 vaccines, the vaccination user journey is available online here. On arrival for a vaccination, recipients are checked that they do not have symptoms that would prevent them from having a vaccine. They are asked questions about their medical history and for consent for the vaccine; at this point, they have the opportunity to ask any questions they may have regarding the vaccination. Once the vaccine has been given, they will be given a leaflet that includes details on possible side effects and how to report those to the MHRA.
The product information for all approved vaccines is available to patients online: Patient Information Leaflets for the Pfizer BioNTech, Astra-Zeneca and Moderna COVID-19 vaccines. Patients are also encouraged to discuss any concerns they may have prior to receiving the vaccine with their healthcare professional.
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.
Kind regards,
FOI Team Vigilance and Risk Management of Medicines Division Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU