FOI release

Freedom of Information request on adverse drug reactions associated with COVID-19 vaccines (FOI 21-362)

Published 28 June 2021

6th May 2021 FOI 21/362

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: According to the UK’s Medicine and Healthcare Regulatory Agency, 30 people have developed blood clots following the administration of the Oxford/AstraZeneca vaccine and out of the 30 people, seven had died as of 24th March 2021. Therefore, please could someone kindly disclose the following information including which part of England the recipients were vaccinated, their age and ethnicity. 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-adverse-reactions/coronavirusvaccine-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 which part of the United Kingdom the recipients were vaccinated. Yellow Card data is releasable to members of the public provided that patient and reporter confidentiality is maintained. Under the Freedom of Information Act (FOIA) 2000 data is releasable as category 1b, patient ethnicity does not fall within this category.  Additionally, it is important to note, that whilst we request patient ethnicity data, this is not a mandatory field and therefore does not need to be provided in order to report to the MHRA. For reports of thromboembolic events with concurrent thrombocytopenia (low platelets) that the MHRA has received, the majority are reported in white British patients. This correlates with the overall Yellow Card reporting profile across all COVID-19 vaccines. However it is important to note that this does not infer which ethnicities experience a greater number of side effects or are more susceptible to adverse reactions when taking COVID-19 vaccines due to many factors; including that the number of doses administered to each ethnic group is not included in MHRA data or the incidence of the events occurring naturally regardless of vaccination between ethnic groups. 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