Freedom of Information request on breakdown of the specific age and sex of those who have experienced suspected blood clots since receiving COVID-19 Vaccine AstraZeneca (FOI 21/377)
Published 28 June 2021
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7th May 2021 FOI 21/377 Dear Thank you for your email dated 08 April 2021, where you requested a breakdown of the specific age and sex of those who have experienced suspected blood clots since receiving the Oxford/AstraZeneca COVID-19 vaccination.
The MHRA has undertaken a thorough review into UK reports of an extremely rare and unlikely to occur specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) occurring together with low levels of platelets (thrombocytopenia) following vaccination with the COVID-19 Vaccine AstraZeneca. It is also considering other blood clotting cases (thromboembolic events) alongside low platelet levels.
Further to your request, 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-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting. In this publication, you will find a breakdown of the age and sex of these patients.
The estimated number of first doses of COVID-19 Vaccine AstraZeneca administered in the UK by 28 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.
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.
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.”
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