Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

Please note that we may not respond if your query: 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 

The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

Our Ref: FOI 21/830
       
Dear Gian A Ameri,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 20th July 2021.
  
I 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 Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000

show quoted sections

FOI 21/830

Dear [Name Removed]

Thank you for your email.

Unfortunately, the information you have requested is exempt under Section
12 (unreasonable use of resources) of the Freedom of Information (FOI)
Act. Section 12 of the Act 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 24 working hours in determining
whether the department holds the information, locating, retrieving and
extracting the information. As your request concerns large amounts of
information, it will not be possible to complete this part of your request
within the 24 working hours stipulated in the FOI Act. For this reason, we
are not processing your request further.

CHM minutes and papers covering many vaccines and across several months is
available to view at the following link of our website page below.

[1]https://www.gov.uk/government/organisati...

Membership of CHM is available to view at this link.

[2]https://www.gov.uk/government/organisati...

We confirm that we do not give out GMC numbers.

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 would 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.

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

Please note that we may not respond if your query: 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 

The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

Internal Review of FOI 21/830
 
Dear [Name Removed],
 
Thank you for your email.
 
We confirm that an internal review will be carried out on FOI 21/830. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.
 
Kind Regards
 
 
MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

Please note that we may not respond if your query: 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 

The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

Dear [Name Removed],

Thank you for your email.

We replied to your request (our reference FOI 21/830) on 11 August 2021. We received your reply, in which you requested an internal review, on 11 August 2021. We responded on 12 August 2021 to confirm that we would conduct an internal review (please find attached a copy of that email for your convenience).

As noted in the attached email, we normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.

Kind Regards

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: [Name Removed]
<[FOI #775244 email]> Sent: Tuesday, November 2,
2021 7:33:13 PM To: MHRA Customer Services Subject: RE: FOI 21/830 CSC
62643 Internal review of Freedom of Information request - Your Advice to
MHRA on UK Government experimental Covid vaccine program Dear MHRA
Customer Services, I never received the outcome of the internal review i
requested. Kindly respond with the outcome of the internal review. Yours
sincerely, [Name Removed] -----Original Message----- Dear [Name Removed],
Thank you for your email. We replied to your request (our reference FOI
21/830) on 11 August 2021. We received your reply, in which you requested
an internal review, on 11 August 2021. We responded on 12 August 2021 to
confirm that we would conduct an internal review (please find attached a
copy of that email for your convenience). As noted in the attached email,
we normally aim to respond to requests for internal review within 20
working days of receipt. However, due to high volumes of queries we are
currently receiving related to COVID-19 please be aware that responses may
take longer than usual. Kind Regards MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade,
Canary Wharf, London E14 4PU
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #775244 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections

Dear [Name Removed],

Thank you for your email.

We have chased your enquiry with our experts and we can only apologise that you have not yet received a response. We have notified the team concerned and they will respond to you as soon as they can.

We are sorry for the length of time you have to wait for a response.

With regards,

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: [Name Removed]
<[FOI #775244 email]> Sent: Tuesday, December 14,
2021 7:55:21 PM To: MHRA Customer Services Subject: RE: FOI 21/830 CSC
62643 Internal review of Freedom of Information request - Your Advice to
MHRA on UK Government experimental Covid vaccine program Dear MHRA
Customer Services, I never received the outcome of the internal review I
requested. Kindly respond with the outcome of the internal review. Yours
sincerely, [Name Removed] -----Original Message----- Dear [Name Removed],
Thank you for your email. We have chased your enquiry with our experts and
we can only apologise that you have not yet received a response. We have
notified the team concerned and they will respond to you as soon as they
can. We are sorry for the length of time you have to wait for a response.
With regards, MHRA Customer Service Centre Medicines and Healthcare
products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14
4PU -------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #775244 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections

Internal Review of FOI 21/830

Dear [Name Removed],

Thank you for your patience whilst we completed our review of FOI 21/830.

The purpose of this review is to determine whether the Agency dealt
properly and fairly with your request under the Freedom of Information Act
(FOIA). In particular, it will examine the reasons why information was
withheld from you.

In consideration of your first question:

“Please provide all communications providing "advice" to the MHRA from you
(CHM) relating to the UK Government experimental Covid vaccine program”

It appears that Section 12 was appropriate to apply to this request,
however, its use should have been accompanied by a fuller explanation. The
number of meetings conducted over the time period specified by your
request was considerable: 22 meetings of the CHM and 50 meetings of the
COVID-19 Vaccines Benefit Risk Expert Working Group, each of these
meetings requires considerable communications between CHM and MHRA, thus
we forecast that the time taken to locate, extract, and retrieve the
information would be in excess of the cost limit. Further, the public
assessment reports (PARs) for the COVID-19 vaccines detail the data
submitted to support the application, and provide an overview of the
assessment of the each COVID-19 vaccine with confidential information
removed. In essence, it is the end product of the considerations of the
assessment team and advice of the Expert Working Groups and the Commission
on Human Medicines (CHM).

Please note that we do not consider the COVID-19 vaccination programme to
be experimental these vaccines were supported by large clinical trials and
a continued understanding of vaccine safety is available from
post‑authorisation surveillance / pharmacovigilance.

PAR COVID-19 vaccine Pfizer: [1]Public Assessment Report
(publishing.service.gov.uk)

PAR COVID-19 vaccine Moderna:
[2]UKPAR_COVID_19_Vaccine_Moderna_07.04.2021_CMA_Reliance_PAR__-__final.pdf
(publishing.service.gov.uk)

PAR AstraZeneca : [3]Public Assessment Report (publishing.service.gov.uk)

With regard to the second point in your request:

“Kindly also provide the names and GMC number of the GMC registered
Doctors who are responsible for providing such advice.”

We previously stated that we do not provide GMC numbers which is correct,
however, for the purposes of the FOI Act we should have exempted this
information under Section 38.* (health and safety). To align a particular
expert with advice they have given on the COVID-19 vaccines could place
them at personal risk. However, a list of members of CHM and the working
group/s are available on our [4]website.

* Section 38 of the ICO guidance explains that, “Information is exempt
information if its disclosure under this Act would, or would be likely to—
(a) endanger the physical or mental health of any individual, or (b)
endanger the safety of any individual.”

This concludes our internal review

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