Freedom of Information request on the clinical trial data for the AstraZeneca COVID-19 vaccine (FOI 22/715)
Published 21 December 2023
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FOI 22/715
7th July 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, as MHRA does not have access to the data package submitted by to the FDA, we cannot confirm whether the data is the same as the data submitted for UK authorisation.
Regarding Q3 (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
I can confirm that no reports, or other events suggestive of the very rare syndrome of thrombosis occurring with thrombocytopenia were reported in the clinical trials of the AstraZeneca COVID-19 vaccine. This risk was identified following receipt of Yellow Card reports of very unusual types of thrombosis occurring with thrombocytopenia in people who had received this vaccine, the MHRA undertook a thorough review into these reports
This scientific review concluded that the evidence of a link with COVID-19 Vaccine AstraZeneca was likely and on 7 April 2021, the MHRA issued a press release informing the public and healthcare professionals of the possible link between the AstraZeneca vaccine and rare blood clots with thrombocytopenia.
At the same time, the information leaflets for patients and healthcare professionals were updated to include information on the possible risk of extremely rare blood clots following this vaccine and advice on symptoms for vaccine recipients to look out for 4 or more days after vaccination.
These cases 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.
These events are extremely rare, with an incidence of 15.8 per million doses of vaccine given. The MHRA’s advice remains that the benefits of the COVID-19 vaccine AstraZeneca outweigh the risks in the majority of people.
The MHRA continues to publish the latest breakdown of all cases of these extremely rare side effects on a weekly basis https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#conclusion-1
The reason why some people develop these extremely rare blood clots with lowered platelets is not yet fully understood. The MHRA have requested that AstraZeneca conduct a series of studies to further investigate the syndrome of thrombosis with thrombocytopenia. These studies have been made a condition of the licence for this vaccine; therefore, AstraZeneca is obliged to conduct them to an agreed timescale and report the findings to the MHRA, and other global regulators for assessment. These studies are summarised in the Public Assessment Report for Vaxzevira (the COVID-19 Vaccine AstraZeneca) which can be found here.
Furthermore, a team of independent researchers and experts in epidemiology, immunology, neurology and haematology have convened a “Thrombosis and thrombocytopenia in COVID-19” Consortium. The Consortium aims to coordinate work in this area to enable further understanding of this syndrome. Specific research areas include investigation into background rates of these events in the general population, and the evaluation of the association between SARS-CoV-2 infection and thrombotic disorders, and COVID-19 vaccination and these events.
The MHRA will continue to carefully evaluate any emerging information on blood clots occurring with thrombocytopenia and will take regulatory action and communicate to the public and healthcare professionals as appropriate.
If you have a query about the information provided, please reply to this email.
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Yours sincerely
MHRA Customer Experience Centre