Freedom of Information request on number of people who have received the Astra Zeneca Vaccine and have reported a blood clot following the vaccination (FOI 21-371)
Published 28 June 2021
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7th May 2021 FOI 21/371 Dear
Thank you for contacting the MHRA regarding the reports we have received concerning a specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) and other blood clotting cases (thromboembolic events) occurring together with low levels of platelets (thrombocytopenia). Under the Freedom of Information (FOI) act, you have requested to be provided with the following: I’d like to request more information regarding the people who have been affected and also died. Out of the 19 who have died only 3 were under 30, and most of the people affected were women - I am wondering why the government has only capped this for under 30s. I’d like to request the demographic data for each person affected by clots following the vaccine and also each fatality. I am 48 and due a vaccine and am no longer confident in this vaccine or the government’s latest decision.
The MHRA publishes a weekly summary of Yellow Card reporting which can be found on this link: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adversereactions/coronavirus-vaccine-summary-of-yellow-card-reporting. 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 fatal reports. The estimated number of first doses of COVID-19 Vaccine AstraZeneca administered in the UK by 28 th of 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. The 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. I would like to highlight that the MHRA does not advise on vaccination policy, this is the remit of the Joint Committee on Vaccination and Immunisation (JCVI). On 7 April 2021, the JCVI advised that based on the available evidence which indicates a finer balance between the balance of risks and benefits associated with the Oxford-AstraZeneca vaccine in adults aged less than 30 years without underlying health conditions which put them at risk of severe COVID-19 disease, individuals in this age group should be offered an alternative COVID-19 vaccine. However, the MHRA are unable to provide medical advice about receiving the vaccine and would recommend you discuss your concerns with your GP or another healthcare professional.
It is important to note that Yellow Card reports are not proof of a side effect occurring due to a vaccine but a suspicion by the reporter that the medicine or vaccine may have caused the side effect. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated. Please consider the following statement by Dr June Raine, MHRA Chief Executive: “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.” 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. Yours sincerely, FOI Team, Vigilance and Risk Management of Medicines Division