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Anna Frances Request-746058-E0cf701a Anna Frances MHRA [email protected] 10 South Colonnade Canary Wharf London E14 4PU United Kingdom www.gov.uk/mhra 7th May 2021 Dear Ms Frances, FOI 21/409 Thank you for your emails to MHRA customer services on 12th April 2021, where you asked questions relating to the COVID-19 vaccines, particularly inquiring on data on thromboembolic events and low platelets. In addition, you requested evidence of informed consent before people receive COVID-19 vaccines. Information on thromboembolic events and low platelets following a COVID-19 vaccine The MHRA has been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at the population level. A summary of Yellow Card reporting concerning the COVID-19 vaccines is published each week and can be found here. In this publication, you will find the specific information you have requested surrounding these case reports, including a breakdown of the age and sex of these patients and how many reports were fatal. The estimated number of first doses of COVID-19 Vaccine AstraZeneca administered in the UK by 28th April was 22.6 million and 5.9 million estimated second doses, giving an overall case incidence of 10.5 per million doses. Taking into account the different numbers of patients vaccinated with COVID-19 Vaccine AstraZeneca in different age groups, there is a higher reported incidence rate in the younger adult age groups compared to the older groups. MHRA advises that this evolving evidence should be taken into account when considering the use of the vaccine. There is now some evidence that the reported incidence rate is higher in females compared to men, although this is not seen across all age groups, and the difference remains small. These reports have also been analysed by the Government’s independent advisory body, the COVID-19 Vaccines Benefit Risk Expert Working Group, which includes lay representatives and advice from leading haematologists. On the basis of this ongoing review, the advice remains that the benefits of the vaccine outweigh the risks in the majority of people. Public Health England (PHE) has provided advice on vaccination in different age cohorts in its leaflet on COVID-19 vaccination and blood clotting document: Information on vaccination. There is currently one suspected report of thromboembolic events with concurrent thrombocytopenia for the Covid-19 Pfizer/BioNtech vaccine, and none currently reported for the COVID-19 Moderna vaccine. Dr June Raine, MHRA Chief Executive, said: “Over 44 million doses of vaccines against COVID-19 have now been administered in the UK, saving thousands of lives through the biggest vaccination programme that has ever taken place in this country. “No effective medicine or vaccine is without risk. These specific kinds of blood clots with low platelets reported following COVID-19 Vaccine AstraZeneca remain extremely rare and unlikely to occur. The benefits of the vaccine continue to outweigh the risks for most people. “It is still vitally important that people come forward for their vaccination when invited to do so. “We ask anyone who suspects they have experienced a side effect linked with their COVID-19 vaccine to report it to the Coronavirus Yellow Card website.” Information on informed consent before receiving a COVID-19 vaccine In your email, you requested proof of the informed consent people were given before receiving the vaccinations and if they were shown the Yellow cards reports from www.gov.uk. 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 this response’s date and can be addressed to this email address. Yours sincerely, FOI Team, Vigilance and Risk Management of Medicines Division The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re- use-mhra-information If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option, please write to the Communications Directorate, 4-T, Medicines and Healthcare products Regulatory Agency (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at: The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF Copyright notice The information supplied in response to your request is the copyright of MHRA and/or a third party or parties and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder. .
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