FOI release

Freedom of Information request on cases of thromboembolic events with concurrent low platelets (FOI 21-554)

Published 13 August 2021

18th June 2021 FOI 21/554

Dear

Thank you for your Freedom of Information (FOI) request dated 20th May 2021, where you requested the following:

“You write in the paragraph ‘Thrombo-embolic events with concurrent low platelets’ that

“Fifteen cases have been reported after a second dose”, out of 9.0 million second doses.

Could you please specify a bit further on these fifteen cases: ages, gender, and fatality? Since the UK real world data are closely followed, a better understanding of risks of the second dose is of great importance for countries like The Netherlands.”

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