FOI release

Freedom of Information request on the clinical trial data for the AstraZeneca COVID-19 vaccine and vaccine-induced immune thrombocytopenia and thrombosis (FOI 22/716)

Published 27 March 2023

FOI 22/716

14th June 2022

Dear

Thank you for your email.

Regarding Q1, the clinical data for the AZ vaccine is available through the European Medicines Agency (EMA), link is provided below:

https://clinicaldata.ema.europa.eu/web/cdp/home

Regarding Q2 (Vaccine-induced immune thrombotic thrombocytopenia (VITT)), the public assessment reports for the assessment of the AZ vaccine by the MHRA and the EMA are presented below:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre