FOI release

Freedom of Information request (FOI 22/1045)

Published 17 January 2024

FOI 22/1045

9th November 2022

Dear

Thank you for your information request, dated 12 October 2022, where you asked the below:

“I am instructed by the Health Advisory & Recovery Team (HART) to submit an FOIA Request to the MHRA requiring it to produce all data and all information* that was submitted by AstraZeneca in the application for license of their Covid-19 vaccine (AZD1222/Vaxzevria) and relied upon in granting a Conditional License for use.

• I am instructed that a full data set and all information are:

1. Pre- and post-authorisation safety and efficacy data for this product.

2. All information that allowed a “rigorous scientific assessment” of all the available evidence of quality, safety and effectiveness by the UK Regulator, the Medicines and Healthcare Product Regulatory Agency (MHRA).

3. All information and full data set that the MHRA stated their expert scientists and clinicians reviewed from the laboratory preclinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and the conditions for its safe supply and distribution.

4. Anonymised data from their clinical trials

This information request in its current format would be exempt under s12 or s14.

Section 12

Section 12 applies when the cost exceeds then limit of 24 hours to determine if the information is held, locate, retrieve, and extract the information. We estimate the time taken to conduct the above activities to be in excess of 36 hours.

Section 14

A Section 14. refusal, can be used in situations where handling multiple requests or a single request, would lead to a grossly excessive burden being placed on the public body or institution. We expect that this burden would be incurred due to the need to read, consider, and apply redactions, to the vast array of regulatory material encompassed by the request. We expect the time taken to conduct redactions to be >300 hours.

In line with the ICO advice, we would suggest that your client considers a refinement of their request before a formal refusal notice is issued. An example of refinement would be for your client to review the public assessment report below, and select a certain study or concept which they find of particular interest. Then should they wish to, your client/s can lodge a refined request or requests. Please note, we cannot guarantee that a request refined in a manner that for example, selects a particularly wide concept area or a major study would not still fall outside the limits of S.12 or prevent a S.14 refusal.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1103097/CMA_UKPAR_COVID_19_Vaccine_AstraZeneca_PAR_16.07.2021.pdf

Should your client consider that they cannot narrow the scope of their request, the Agency will consider it to appropriate to apply S.14

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

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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.

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