Reports and Data to meet Conditions of Authorisation for Vaxzevria
Dear Medicines and Healthcare Products Regulatory Agency,
You have defined a set of Conditions of Authorisation for Vaxzevria. I would be grateful if you could provide several of the plans/reports/data you now hold in satisfaction of those conditions.
Specifically:
1. The final report for a non-clinical study to test in-vitro expression of the S protein of Vaxzevria to elucidate the possible mechanisms of platelet activation after vaccination and to identify the possible triggers. According to your web site (Conditions of Authorisation for Vaxzevria) this document was due publication on 31 July 2021
2. Submission of a plan in RMP, timelines and protocols to further characterise the thrombosis and thrombocytopenia syndrome associated to the vaccine and elucidate its mechanism, the MAH should conduct suitable clinical studies. These documents were due publication on 31 Aug and 30 Sep 2021
3. 6-month and validated follow-up immunogenicity data of the COV trials to evaluate antibody persistence. This data was due publication on 31 July 2021
4. Updated data from the COV002 study to further evaluate vaccine efficacy against transmission. Due 31 Jan 2022
5. Data on breakthrough cases to investigate potential correlate(s) of protection.
5a. This report was due publication on 31 July 2021; both the 27 January and 27 June 2022 updates of your web site page (Conditions of Authorisation for Vaxzevria) showed this publication date.
5b. Was this an error in reporting to the public or are you withholding the report? If it was an error and the MAH was authorised to delay publication for at least 11 months, please supply communications and/or minutes of a meeting showing when and how this decision was made.
Yours faithfully,
CHP Gillow
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
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,
'Reports and Data to meet Conditions of Authorisation for Vaxzevria'
You have not replied to my request submitted on 4 February 2023 - see https://www.whatdotheyknow.com/request/r...
You unilaterally proposed to 'merge' this request with another request ("AZ Vaxzevria Trial D8111C00004 (UK)") - see https://www.whatdotheyknow.com/request/a...
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 'Reports and Data to meet Conditions of Authorisation for Vaxzevria'. A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/r...
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 ("AZ Vaxzevria Trial D8111C00004 (UK)") - see https://www.whatdotheyknow.com/request/a...
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
Dear CHP Gillow
Please find attached the response to your delayed request FOI 23/105. Due
to the size of some of the attachments, I’ll send the documents we’re
disclosing in a series of emails just to ensure they arrive with you. The
emails will be marked so you know you have received everything – if
anything doesn’t come through to you, please let me know.
Please note the number of emails I’m sending in response to this
whatdotheyknow page will differ slightly from those I have sent to you
separately. I haven’t received a bounce back message for any of those I
sent directly to you – but I did when I forwarded them on to the ICO, so
I’m conscious that the original Email 2 was very large. I’ve amended the
list of emails below.
The emails are listed below. There are no documents disclosed for
Questions 4 and 5 of the request for Conditions of Authorisation for
Vaxzevria; links are provided to published documents for these questions
in the response letter. Email 4 contains 3 documents for your request for
information on AZ Vaxzevria Trial D8111C00004; these 3 documents have
already been provided to you in response to your previous request FOI
22/1080, but I thought it useful to provide them again with the other
disclosures. My contribution to the response letter has been to ensure
that all document titles are set out in the response for clarity, and to
confirm where information had been provided to you for your earlier
request.
I will issue the same response and disclosures to the two whatdotheyknow
pages for these requests – this may be tomorrow morning, as I have had
some issues in the past with larger documents uploading there first time
(I’ve had to split them on previous occasions). I will also send through a
copy of everything to the ICO for their records to confirm that the action
in their decision notice IC-235626-T4Y2 has been completed.
Email 1: response letter and 3 disclosure documents for Question 1 of
request for Conditions of Authorisation for Vaxzevria
Email 2: 2 disclosure documents for Question 2 of request for Conditions
of Authorisation for Vaxzevria
Email 3: 1 disclosure document for Question 2 of request for Conditions of
Authorisation for Vaxzevria
Email 4: 4 disclosure documents for Question 3 of request for Conditions
of Authorisation for Vaxzevria
The 3 disclosure documents for the request Information on AZ Vaxzevria
Trial D8111C00004, which was also logged as FOI 23/105 will be sent in a
separate email to that request page
[1]https://www.whatdotheyknow.com/request/a....
I will also include a copy of the response for FOI 23/105 which covers
your two individual requests.
Please let me know if you have any issues receiving the documents.
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
Visible links
1. https://www.whatdotheyknow.com/request/a...
2. https://www.gov.uk/help/terms-conditions
Dear CHP Gillow
Please find attached 2 disclosure documents for Question 2 of request for
Conditions of Authorisation for Vaxzevria, request FOI 23/105.
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
[1]DHTermsAndConditions
References
Visible links
1. https://www.gov.uk/help/terms-conditions
Dear CHP Gillow
Please find attached 1 disclosure document for Question 2 of request for
Conditions of Authorisation for Vaxzevria, request FOI 23/105.
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
[1]DHTermsAndConditions
References
Visible links
1. https://www.gov.uk/help/terms-conditions
Dear CHP Gillow
Please find attached 4 disclosure documents for Question 3 of request for
Conditions of Authorisation for Vaxzevria, request FOI 23/105. This
completes the disclosure documents for this request.
As mentioned in my initial email, the 3 disclosure documents for the
request Information on AZ Vaxzevria Trial D8111C00004, which was also
logged as FOI 23/105 will be sent in a separate email to that request page
[1]https://www.whatdotheyknow.com/request/a....
I have also included a copy of the response for FOI 23/105 which covers
your two individual requests.
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
Visible links
1. https://www.whatdotheyknow.com/request/a...
2. https://www.gov.uk/help/terms-conditions
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