FOI release

Freedom of Information request (FOI 22/931)

Published 17 January 2024

FOI 22/931

27th September 2022

Dear

Thank you for your request on 29th August 2022 where you requested the following:

1. Study number D8111C00004 identified on page 54 of Reference A as a Phase IV Non Interventional Enhanced Active Surveillance Study of Adults Vaccinated with AZD1222, designed to “To estimate the incidence of SAEs, AESIs, and medically attended AEFIs after at least one IM dose of AZD1222 for 3 months after vaccination”) and as a “Category 3 - Required additional pharmacovigilance activity”

1 a . Please provide a copy of the study protocol and confirmation that the study began on 8 June 2021.

1 b. Please provide the interim report due in Q3 2021.

Should this information not be available, please explain why and provide the closest alternative including substitutes from D8111R00003 (EU) and/or (EU) D8110R00001 (US)

1. Please confirm the publication plans for the final Clinical Study Reports (due date 30 September 2022) on the trial subjects after they have been followed for 1 year post second dose for the randomised, controlled, COV001, COV002, COV003 and COV005 - see page 63 in Ref A.

2. Please confirm the publication plans for the final analysis from the pooled pivotal studies (due date 30 September 2022) - see page 63 in Ref A.

3. Please provide detailed analyses of the data produced on breakthrough cases, intended to investigate potential correlate(s) of protection, due publication on 31 January 2022. 

Answers to your requests have been provided below.

1. The Enhanced active surveillance (EAS) studies (EAS (D8111R00003 [EU], D8110R00001 [US], D8111C00004 [UK]) have been removed as post authorisation safety studies (PASS). The reason for this being recruitment challenges for study D8111R00003, due to National Immunization Technical Advisory Groups (NITAGs) recommendations restricting Vaxzevria use to elderly age groups. Source RMP on the EMA website [vaxzevria-previously-covid-19-vaccineastrazeneca-epar-risk-management-plan_en.pdf (europa.eu)]

1.a and 1.b are considered not applicable based on the above. If you are still require these documents, knowing that the study is not going ahead, please come back to us.

1. Data not held. Once the assessment of the new data has concluded, we expect the information to be published <60 days. However, please note that at renewal the due date, has been revised to 31 December 2022.

2. Data not held. Once the assessment of the new data has concluded, we expect the information to be published <60 days. However, please note that at renewal the due date, has been revised to 31 December 2022.

3. Data not held. Similarly, to the above please note that at renewal, the due date has been revised to 31 December 2022.

The revised list of conditions is due to be published online shortly, we thank you for bringing this omission to our attention. Please find attached a PDF which outlines the revised conditions.

Before submitting further requests we kindly ask that you first review the information available online on the EMA repository, and then follow the instructions detailed below.

To visit the EMA repository online please follow the link above, on the right hand side of the page will be some text instructing new users to create an account (refer to screenshot below). Once an account is created the product can be search and the clinical data and be scrolled through using the arrow keys on the keyboard to navigate. For a description of the clinical data available on the site please see, Clinical data available - Clinical Data Publication - clinicaldata.ema.europa.eu.

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

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 you receive this response and addressed to: info@mhra.gov.uk

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

We appreciate that this news may be disappointing, but when viewed against the context of the volume of requests that you have made to MHRA we feel that this has been a necessary step to help preserve our administrative and technical resource.

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 FOI Team