AZ Vaxzevria Trial D8111C00004 (UK)

The request was successful.

Dear Medicines and Healthcare Products Regulatory Agency,

I am requesting the information you hold on AZ Vaxzevria Trial D8111C00004 (UK) apparently referred to in the November 2020 EMA RMP v1 as "ESR 21-21121 [UK] Ph IV Enhanced Active Surveillance"

I note a change in Version 4 of the EMA RMP, dated December 2021, removing D8111C00004 (UK) (and D8111R0003(EU) and D8110R00001 (US)) "due to recruitment challenges for study D8111R00003 (EU)" This followed a decision to that effect by the CHMP in November 2021.

Though removed as 'requirements' in December 2021, by that date there should have been the following material in place:

- Study Design Concept (11 Dec 2020)
- Study Protocol (28 Jan 2021),
- First interim report Q3 2021.

Please provide copies of these documents as well as confirmation that the study began on 8 June 2021 and what organisation led the work.

Please confirm whether the trial was terminated and, if so, when. If the trial continued, please confirm what organisation leads the work, what results are (will be) available and when.

Yours faithfully,

CHP Gillow

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 23/105

Dear CHP Gillow,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 04 February 2023.

There are two FOI requests which has been merged and treated under one FOI reference FOI 23/105.

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

show quoted sections

Dear MHRA Customer Services,

I note your suggestion that you intend to "merge" two FOIA requests under FOI 23/105.

While this may make the process expeditious, please do not "merge" my requests if there is any possibility of the delivery of any of the information being delayed as a result.

Also, please do not "merge" the requests if there is any possibility of the resulting information request falling foul of an exemption under the Act.

Yours sincerely,

CHP Gillow

Dear MHRA Customer Services,

You have not replied to my request submitted on 4 February 2023 - see https://www.whatdotheyknow.com/request/a...

You unilaterally proposed to 'merge' this request with another request ("Reports and Data to meet Conditions of Authorisation for Vaxzevria") - see https://www.whatdotheyknow.com/request/r...

At the time I replied to push back on your proposed 'merger' of these two FOIA requests under FOI 23/105.

I acknowledged that, while this might make the process expeditious, you should not "merge" my requests if there is any possibility of the delivery of any of the information being delayed as a result. You have now gone over 25 working days without responding. I also, asked you not to "merge" the requests if there is any possibility of the resulting information request falling foul of an exemption under the Act.

Clearly, your proposed merger has not left you in a position to comply with the law.

An update and explanation would be appreciated.

Yours sincerely,

CHP 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 'AZ Vaxzevria Trial D8111C00004 (UK). A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/a...

I submitted this request on 4 February 2023 and the information I requested remains to be supplied over 13 weeks after my request. On 7 February 2023, you unilaterally proposed to 'merge' this request with another request "Reports and Data to meet Conditions of Authorisation for Vaxzevria" (See https://www.whatdotheyknow.com/request/r... ) At the time I replied to push back on this proposed 'merger' of these two FOIA requests under FOI 23/105.

Clearly, your proposed merger has not left you in a position to comply with the law.

Yours faithfully,

CHP Gillow

CHP Gillow left an annotation ()

ICO have ordered MHRA to respond by 20 June 2023

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Requests FOI/ 23 105 and FOI/23 266

 

Dear CHP Gillow

 

I have recently joined the Medicines and Healthcare products Regulatory
Agency as the Freedom of Information Manager. I understand that you have
contacted the Information Commissioner to advise of delays in the handling
of requests you have made to the MHRA, and that the Information
Commissioner has asked us to respond to two delayed requests by today,
June 20^th. These are FOI 23/105 and FOI 23/266. I have sent this email to
the webpages for both requests.

 

I am writing to advise you that we will not be able to issue the responses
to FOI 23/105 and FOI 23/266 today as we had hoped. I have made enquiries
and can confirm that we are working to complete these responses and issue
them to you within the next 7 days. I am sorry for this further delay, and
I have written to the Information Commissioner’s Case Officer to advise
them of this.

 

I would also like to take this opportunity to invite you to discuss your
requests with me. I can see that some of your more recent requests are
related to the handling of your earlier requests; while I understand this
is a way to explore the handling of the previous requests, I note that you
have also asked for internal reviews for a number of requests including
those where information was disclosed to you. I appreciate that you may
wish to continue to pursue both avenues, but I wondered if a further
discussion about the types of information you are interested in would be
of assistance to you.

 

If this would be helpful for you, you are welcome to contact me in the
first instance via the usual MHRA Customer Service email address; if you
would like to speak, please let me know and we can make arrangements.
Separately to this, I will contact you with reference numbers for the
internal reviews in due course.

 

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
Telephone 020 3080 6000

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Lander, Lou, Medicines and Healthcare Products Regulatory Agency

Dear CHP Gillow

 

I am writing to update you regarding the delayed response to your request
FOI/23 105. I am sorry to advise that I have not been able to complete the
response to this request in time to meet the Information Commissioner’s
deadline of 27 June 2023, and I apologise that this response has exceeded
the 20 day time frame of FOI by some margin.

 

As we discussed yesterday, a not insignificant number of documents have
been retrieved for this request, and we are continuing to work to review
these and prepare your response. I have a further meeting on this
tomorrow.

 

I understand that the ICO may proceed to issue a decision notice regarding
the breach of section 10 that has occurred, and I will provide a copy of
this update to them.

 

You are welcome to contact me with any queries.

 

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

 

DISCLAIMER This email and any files transmitted with it are confidential.
If you are not the intended recipient, any reading, printing, storage,
disclosure, copying or any other action taken in respect of this email is
prohibited and may be unlawful. If you are not the intended recipient,
please notify the sender immediately by using the reply function and then
permanently delete what you have received. Incoming and outgoing email
messages are routinely monitored for compliance with the Department of
Health's policy on the use of electronic communications. For more
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Lander, Lou, Medicines and Healthcare Products Regulatory Agency

4 Attachments

Dear CHP Gillow

 

Please find attached 3 disclosure documents for your request for
information on the AZ Vaxzevria Trial D8111C00004. These were also
disclosed to you for your previous request FOI 22/1080. I’ve also attached
a copy of the response to FOI 23/105 which covered this request.

 

The response and disclosures for your second request logged under the FOI
23/105 reference number have been uploaded to your separate request page
here:

[1]https://www.whatdotheyknow.com/request/r...

 

 

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

 

DISCLAIMER This email and any files transmitted with it are confidential.
If you are not the intended recipient, any reading, printing, storage,
disclosure, copying or any other action taken in respect of this email is
prohibited and may be unlawful. If you are not the intended recipient,
please notify the sender immediately by using the reply function and then
permanently delete what you have received. Incoming and outgoing email
messages are routinely monitored for compliance with the Department of
Health's policy on the use of electronic communications. For more
information on the Department of Health's email policy, click
[2]DHTermsAndConditions

References

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2. https://www.gov.uk/help/terms-conditions