FOI release

Freedom of Information request on adverse thromboembolic events post COVID-19 Vaccine AstraZeneca (FOI 21-547)

Published 13 August 2021

14th June 2021 FOI 21/547

Dear

Thank you for your Freedom of Information (FOI) request regarding adverse thrombo-embolic events post COVID-19 Vaccine AstraZeneca.

Under the Freedom of Information (FOI) act, you have requested to be provided with the following regarding suspected thrombo-embolic events with concurrent thrombocytopenia:

I. Number of reports following a first dose

II. Number of fatal reports following a first dose

III. Number of reports following a second dose

IV. Number of fatal reports following a second dose

V. Number of first doses administered

VI. Number of second doses administered

As you may be aware, the MHRA publish a weekly COVID-19 ADR summary alongside analysis prints for each vaccine, these can be found here. It currently pertains to data received up to 2 June 2021. This contains details regarding specific reports including thrombo-embolic events with concurrent low platelets.

The estimated number of first doses of COVID-19 Vaccine AstraZeneca administered in the UK by 26 May was 24.3 million and the estimated number of second doses was 13.4 million.

The overall incidence after first or unknown doses was 13.6 per million doses. Taking into account the different numbers of patients vaccinated with COVID-19 Vaccine AstraZeneca in different age groups, the data shows that there is a higher reported incidence rate in the younger adult age groups following the first dose compared to the older groups. (18.0 per million doses in those aged 18-49 years compared to 10.2 per million doses in those aged 50 years and over). 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.

The overall incidence after second doses was 1.3 per million doses. All reported cases following a second dose are in patients aged 50 years and over, for whom the reported incidence rate is 1.4 per million second doses. Currently, no cases have been reported following a second dose in patients aged 18-49 years with an estimated 2.7 million in this age group having received both doses. This should not be directly compared to the incidence rate reported after the first dose as the time for follow-up and identification of cases after second doses is more limited. However, the data are reassuring at this stage and suggest that the reported incidence rate following a second dose is lower than that seen following a first dose. 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.

Regarding your remaining questions on fatal reports, we can confirm that we do hold this information however as we intend to publish the data 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 however wish to publish this information alongside appropriate context and assessment.

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