Inventory of items submitted in support of Vaxzevria's Temporary and Conditional Marketing Authorisations
Dear Medicines and Healthcare Products Regulatory Agency,
BACKGROUND
In an earlier response to an FOIA request, you have stated:
“The main efficacy and safety results for the Phase I, II and III trials for all authorised vaccines have been submitted to MHRA, sufficient that these vaccines can be authorised for use in the patient populations stated in the Information for Healthcare Professionals/Summary of Product Characteristics for each vaccine. These studies are currently ongoing to follow-up vaccine recipients to collect additional safety data, in the same way that all clinical trials for new medicines follow up their study subjects after the main results of the study have been reported....The estimated dates for the end of completion of the clinical trials are as follows: AstraZeneca Phase I/II Estimated Study Completion Date: November 15, 2021; AstraZeneca Phase III Estimated Study Completion Date: February 14, 2023 ”
You released the Astrazeneca vaccine / Vaxzevria under an ‘expedited rolling review’ leading to Temporary Authorisation (30 December 2020) under Regulation 174 of the Human Medicines Regulations 2012 and a subsequent Conditional Marketing Authorisation (24 June 2021). In respect of the Temporary Authorisation, you stated in a Press Release, dated 30 December 2020, that “Oxford University/AstraZeneca has been submitting data to the MHRA since September 2020 under the rolling review process, enabling data to be reviewed in stages, as it became available.“ The Conditional Marketing Authorisation was granted conditional on a set of post-authorisation measures and obligations.
MHRA has been asked by others to provide, inter alia, the full set of data on quality, safety and efficacy reviewed by MHRA in respect of the AstraZeneca (Vaxzevria) vaccine in support of these Temporary and Conditional Authorisations.
THIS REQUEST
Pending release of the full set of data on quality, safety and efficacy reviewed by MHRA, would you please provide me with:
1. A full list, inventory, or manifest of the documents, packages, and data sets *submitted to MHRA in support of the Temporary Authorisation under Regulation 174*.
2. A further list, inventory or manifest of the additional documents, packages, and data sets *submitted to MHRA in support of the Conditional Marketing Authorisation*.
3. A further list, inventory or manifest of additional documents, packages, and data sets that have been *submitted to MHRA in compliance with the post-authorisation measures and obligations specified alongside the CMA*.
4. A further list, inventory or manifest of still outstanding documents, packages, and data sets specified in conjunction with the CMA as *post-authorisation measures and obligations, yet to be submitted to MHRA*.
For each listed document, package, or data set, please supply, where possible, Unique reference number or identifier; Short title; Longer description where retrievable; Version number/Date; Number of pages (as shown on first page).
For documents in list 4 above, please supply an anticipated/expected date of delivery instead of Version number/date and Number of pages.
Should there be a problem with producing one or more of the above lists, please provide what you can as well as an explanation of why some of the information cannot be provided. In any event, please confirm that MHRA holds all the above information.
Yours faithfully,
CHP Gillow
Our Ref: FOI 23/073
Dear CHP Gillow
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 27 January 2023.
We confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.
If you need to contact us again about this request, please quote the reference number above.
Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...
Kind Regards,
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
Dear MHRA
By law, the MHRA should normally have responded promptly and by 24 February 2023.
Yours sincerely,
CHP Gillow
CHP Gillow left an annotation ()
Further chase email sent 11 April 2023:
Dear Medicines and Healthcare Products Regulatory Agency,
Your Ref: FOI 23/073
Reference - Inventory of items submitted in support of Vaxzevria's Temporary and Conditional Marketing Authorisations - a Freedom of Information request to Medicines and Healthcare Products Regulatory Agency - WhatDoTheyKnow
This FOIA Request, dated 27 January 2023, remains unanswered – see Ref link above.
While you acknowledged receipt on 29 January 2023, no further communication has been received. I should, by law, have received a response by 24 February 2023.
I have chased this FOI response via the WhatDoTheyKnow web site and by two emails (4 April and 11 April). Your response should have been provided over six weeks ago.
I would be grateful for a reply either to this email of directly to my FOIA request on WhatDoTheyKnow.
Charles Gillow
Dear Medicines and Healthcare Products Regulatory Agency,
Please pass this on to the person who conducts Freedom of Information reviews.
I am writing to request an internal review of Medicines and Healthcare Products Regulatory Agency's handling of my FOI request 'Inventory of items submitted in support of Vaxzevria's Temporary and Conditional Marketing Authorisations'.
The basis for my complaint is clearly stated in my communication dated 11 April 2023 which is part of the full history of my FOI request and all correspondence available on the Internet at this address: https://www.whatdotheyknow.com/request/i...
Yours faithfully,
CHP Gillow
Our ref: FOI 23/073
Dear Mr Gillow,
Thank you for your request of 27 January 2023, we apologise for the long
delay in reply.
We have been looking into your request for an inventory of documents
(split into four separate listings), and our estimates to date indicate
that Section 12 of the Freedom of Information Act will apply to your
request. Section 12 allows public authorities to refuse requests where the
cost of dealing with them would exceed the appropriate limit, which for
central government is set at £600. This represents the estimated cost of
one person spending 24 working hours in determining whether the department
holds the information, locating, retrieving and extracting the
information. We estimate that it will take us at least 35 hours to comply
with your request, though potentially longer.
The data which we hold on the AstraZeneca vaccine (or indeed any licensed
medicine) is not held in such a way that an inventory can easily be
extracted. In the case of your request, our technical support team have
determined that it would take them at least 35 hours to perform these
extraction activities. Please note, this does not take account of the time
that would then be required to sort through the extracted inventory into
the four areas which you have asked about. Further, this estimate only
covers one of our platforms, we also have another software for document
management, we have made a similar for a time estimate to produce an
inventory for this software to our technical support team and this is
pending. However, as the 24 hour limit has already been exceeded, and we
do not wish to further delay this response by waiting on that estimate.
We would be happy to consider a refined request if you wish to make one,
however, we do not recognise any obvious means by which to propose a
refinement. For example, we could suggest that you limit your request to a
single regulatory procedure or update, but there are a wide range of
regulatory events that occur during a product’s lifecycle and we are not
currently sure which regulatory procedure is of interest to you.
Please also note the EMA include a detailed list of variations and safety
updates for this vaccine on their website, these documents may be of
interest to you and may assist you to refine your request.
[1]Vaxzevria (previously COVID-19 Vaccine AstraZeneca) | European
Medicines Agency (europa.eu)
[2]Vaxzevria, COVID-19 Vaccine (ChAdOx1-S [recombinant]) (europa.eu) –
procedural steps.
We apologise once more for the delay in response.
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: [3][MHRA request email]
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
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear CHP Gillow
I sincerely apologise for the delay in responding to your request FOI
23/265 and I am now writing to provide the response to your request. This
request asked:
“I would be grateful if you could provide me with copies of all internal
communications held by MHRA relating to FOIA request 23/073.”
Please find attached a document containing the requested correspondence.
I’ve set out some points to note here:
• In accordance with section 1(4) of the FOIA, the information disclosed
contains the communications held at the time that your request was
made, 11 April 2023. The discussions contained in this disclosure
reflect considerations as they were in the earlier stages of the
handling of that request.
• As with the previous disclosure of FOI 23/266, the only exemption
applied is section 40(2) for staff personal information, and I’ve
indicated throughout the document where this has been applied.
• No other exemptions have been applied to the correspondence. As the
request was made through the public website, I have not removed the
name on the requests or the few instances where correspondence refers
to ‘CHP Gillow’ in connection with these public requests.
• Where they are included in the chains of email, I have disclosed the
mailbox names and email addresses for MHRA public-facing mailboxes. I
have also disclosed any references to the ‘FOI policy’ mailbox and
email address, however, please be aware that this mailbox is no longer
used for public correspondence. (Enquiries regarding FOI should be
directed to MHRA Customer Services.)
• The disclosure document contains two email ‘chains’. While preparing
disclosures for your remaining delayed requests for internal
correspondence (FOI 23/260 and this request FOI 23/265) I have given a
number to the start of each chain or email. Where in the previous
correspondence to you (FOI 23/266) I included duplicated emails which
appeared in more than one chain, I have now tried to include emails
only once in the main chain or chains if possible – where earlier
emails in a chain appear more than once, I have indicated this by
including squared brackets at the end of a small chain and a direction
to where the remaining emails appear in a longer chain.
• The above approach provides you with all relevant information, but by
avoiding duplication I have reduced the amount of time needed for
redaction of names within quite long chains of duplicated emails.
• The chains in this disclosure document are as follows:
◦ PDF page 1: Email chain 1. The chain contains all correspondence up
to the time of your request bar the initial acknowledgement of your
request which I have included as Email chain 2.
◦ PDF page 18: Acknowledgement of your request from MHRA and original
request.
• Please note that PDF page 8 contains an email where two further emails
were embedded as attachments. The titles of these emails show they
contain copies of your other ongoing requests at that time – FOI
23/105 and FOI 23/1080 – and these emails are the same as those
provided in the responses to your other requests FOI 23/266 (which
asked for all correspondence in the handling of FOI 23/105) and FOI
23/260 (which asked for copies of all correspondence in the handling
of FOI 22/931 and FOI 22/1080).
Yours sincerely
Lou Lander
Freedom of Information Manager
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Appeal rights
If you are dissatisfied with this response, you may ask for an internal
review. If you remain dissatisfied, you may ask the Information
Commissioner (ICO) to make a decision on whether or not we have
interpreted the FOIA correctly in dealing with the request and subsequent
internal review. The ICO’s address is:
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
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CHP Gillow left an annotation ()
Chase email sent 4 April 2023:
Dear Medicines and Healthcare Products Regulatory Agency,
Reference - Inventory of items submitted in support of Vaxzevria's Temporary and Conditional Marketing Authorisations - a Freedom of Information request to Medicines and Healthcare Products Regulatory Agency - WhatDoTheyKnow
My FOIA Request, dated 27 January 2023, remains unanswered – see Ref link above.
While you acknowledged receipt on 29 January 2023, no further communication has been received. I should, by law, have received a response by 24 February 2023.
I would be grateful for a reply either, to this email of directly to my FOIA request on WhatDoTheyKnow.
Charles Gillow