FOI release

Freedom of Information request on the COVID-19 AstraZeneca vaccine (FOI 21-537)

Published 13 August 2021

17th June 2021 FOI 21/537

Dear

Thank you for your email dated 20th May 2021, where you requested the following information for the COVID-19 Vaccine AstraZeneca under the FOI act:

1) How many 45-49-year olds have been given the AstraZeneca vaccine since 14 April 2021? I’m not interested in the figures before that date, just the figure after that date.

2) How many suspected thrombo-embolic events with concurrent thrombocytopenia ADR reports have there been for that particular group? (45-49-year olds given the AstraZeneca vaccine after 14 April 2021). Also, how many fatalities from thrombo-embolic events with concurrent thrombocytopenia in that group?

3) How many total thrombo-embolic events of any type ADR reports have there been for that particular group?

4) How many fatalities that may have been linked to the vaccine have been reported for that group?

Regarding your question surrounding how many 45-49-year olds have been given the COVID-19 Vaccine AstraZeneca since 14th April 2021, we can confirm that the MHRA does not hold this data. Please be assured that the MHRA consider the different numbers of patients vaccinated with COVID-19 Vaccine AstraZeneca in different age groups during assessment and our evidence-based decision making. However, Public Health England hold this information and have published interactive graphs and tables on the number of people who have been vaccinated which is available here: https://coronavirus.data.gov.uk/details/vaccinations. Please contact them directly if you require a further breakdown: https://www.gov.uk/government/organisations/public-health-england.

Your further questions enquire about specific breakdowns of ADR reports concerning suspected thrombo-embolic events with concurrent thrombocytopenia, total thrombo-embolic events and fatalities for the 45-49 age group. 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/coronavirus-vaccine-summary-of-yellow-card-reporting. In this publication, you will find a breakdown of the number of reports of suspected thrombo-embolic events with concurrent thrombocytopenia, as well as the total number of fatalities associated with this specific event for the 40-49 age group. It is noted that this is a wider age bracket than detailed in your FOI request however due to patient and reporter confidentiality we are only able to provide Yellow Card data in 10-year age brackets.

Further to requests 3 and 4, the MHRA is considering the best way to make more granular ADR data publicly available alongside our weekly report. Decisions on the precise breakdown may depend on deployment decisions made by JCVI.

However, as we plan to make more granular ADR data publicly available, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure. Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld.

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