Freedom of Information request (FOI 22/883)
Published 17 January 2024
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FOI 22/883
7th September 2022
Dear
Thank you for your email dated 9th August 2022, whereby you provided clarification that your enquiry relates to any thromboembolism, and also relates to thromboembolism in the absence of low platelet count, in response to the following questions previously asked by the MHRA in FOI 22/798:
“Whether your enquiry solely relates to pulmonary embolism in association with COVID-19 Vaccine AstraZeneca, or if your enquiry relates to any thromboembolism”.
“Whether your enquiry relates to the risk of thromboembolism in the absence or presence of low platelet count”.
The data provided in response to your previous FOI included terms under the grouping “embolic and thrombotic events, venous”, therefore this included the term pulmonary embolism, but also included other venous thromboembolic events.
As previously mentioned, the current evidence does not suggest that the COVID-19 Vaccine AstraZeneca increases the risk of venous thromboembolic events (i.e deep vein thrombosis /pulmonary embolism) that occur without an accompanying reduction in platelet count. There is evidence of a link between the COVID-19 Vaccine AstraZeneca and thromboembolic events with concurrent low platelets. The previously provided data in FOI 22/798 was not specific to reports of thromboembolism with concurrent low platelets, and therefore may include reports of venous thromboembolism in the absence of low platelet count.
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