Essential safety documents relating to BNT162b2

Matt Cooper made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

Medicines and Healthcare Products Regulatory Agency did not have the information requested.

Dear Medicines and Healthcare Regulatory Agency,

I would like to request the following documents relating to the provisional approval of the Pfizer-BionTech BNT162b2 vaccine in December 2020:

1. All documents relating to the MHRA's assessment of the risk of and/or presence of micro-RNA sequences (miRNA) comprised within the Comirnaty mRNA active ingredient (mRNA genomic sequence).

2. All documents relating to the MHRA's assessment of the risk of and/or presence of Oncomirs (oncogenic miRNA - microRNA) comprised within the Comirnaty mRNA active ingredient (mRNA genomic sequence).

3. All documents relating to the MHRA's assessment of the risk of and/or presence of Stop Codon read-through (suppression of stop codon activity) arising as a result of the use of pseudouridine in the Comirnaty mRNA active ingredient (mRNA genomic sequence).

4. Any document showing that the MHRA has assessed the composition of the final protein product (molecular weight and amino acid sequence) produced following injection of the Comirnaty mRNA product in human subjects.

5. All documents relating to the MHRA's assessment of the risk of the use of the
AESmtRNR1 3' untranslated region of the Comirnaty mRNA product in human subjects.

Yours faithfully,

Matt Cooper

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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
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• 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: Matt Cooper
<[FOI #835252 email]> Sent: Monday, February 21,
2022 1:31:22 PM To: MHRA Customer Services Subject: Freedom of Information
request - Essential safety documents relating to BNT162b2 Dear Medicines
and Healthcare Regulatory Agency, I would like to request the following
documents relating to the provisional approval of the Pfizer-BionTech
BNT162b2 vaccine in December 2020: 1. All documents relating to the MHRA's
assessment of the risk of and/or presence of micro-RNA sequences (miRNA)
comprised within the Comirnaty mRNA active ingredient (mRNA genomic
sequence). 2. All documents relating to the MHRA's assessment of the risk
of and/or presence of Oncomirs (oncogenic miRNA - microRNA) comprised
within the Comirnaty mRNA active ingredient (mRNA genomic sequence). 3.
All documents relating to the MHRA's assessment of the risk of and/or
presence of Stop Codon read-through (suppression of stop codon activity)
arising as a result of the use of pseudouridine in the Comirnaty mRNA
active ingredient (mRNA genomic sequence). 4. Any document showing that
the MHRA has assessed the composition of the final protein product
(molecular weight and amino acid sequence) produced following injection of
the Comirnaty mRNA product in human subjects. 5. All documents relating to
the MHRA's assessment of the risk of the use of the AESmtRNR1 3'
untranslated region of the Comirnaty mRNA product in human subjects. Yours
faithfully, Matt Cooper
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/517

Dear Matt Cooper,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 21st February 2022.

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 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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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 22/517

Dear Matt Cooper,

Thank you for your email.

The non-confidential parts of MHRA's assessment report for the Pfizer/BioNTech vaccine for the regulation 174 authorisation are published in the PAR, a link to this is provided below:

https://eur01.safelinks.protection.outlo...

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

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

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
Telephone 020 3080 6000

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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 'Essential safety documents relating to BNT162b2'.

The request was for documents of risk assessments undertaken by MHRA, not by the manufacturer (as those may be exempt from FOI).

ICO guidance is clear on the fact that a public body cannot use this exemption when the confidential document originates from the same public body, except for very limited circumstances.

Please state which exemptions were invoked and the reasons for doing so.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/e...

Yours faithfully,

Matt Cooper

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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: Matt Cooper
<[FOI #835252 email]> Sent: Sunday, March 13, 2022
10:35:38 AM To: MHRA Customer Services Subject: Internal review of Freedom
of Information request - Essential safety documents relating to BNT162b2
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 'Essential safety documents
relating to BNT162b2'. The request was for documents of risk assessments
undertaken by MHRA, not by the manufacturer (as those may be exempt from
FOI). ICO guidance is clear on the fact that a public body cannot use this
exemption when the confidential document originates from the same public
body, except for very limited circumstances. Please state which exemptions
were invoked and the reasons for doing so. A full history of my FOI
request and all correspondence is available on the Internet at this
address:
https://eur01.safelinks.protection.outlo...
Yours faithfully, Matt Cooper
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #835252 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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 22/517

Dear Matt Cooper,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/517. 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 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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Dear MHRA Customer Services,

I await the internal review.

Yours sincerely,

Matt Cooper

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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: Matt Cooper
<[FOI #835252 email]> Sent: Monday, August 1, 2022
6:21:05 PM To: MHRA Customer Services Subject: Re: Internal Review of FOI
22/517 - RE: Internal review of Freedom of Information request - Essential
safety documents relating to BNT162b2 Dear MHRA Customer Services, I await
the internal review. Yours sincerely, Matt Cooper -----Original
Message----- Internal Review of FOI 22/517 Dear Matt Cooper, Thank you for
your email. We confirm that an internal review will be carried out on FOI
22/517. 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 Experience Centre
Communications and engagement team Medicines and Healthcare products
Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #835252 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...
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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Cooper,

Thank you for your email.

We apologise you have not yet received a response and we have followed up with the relevant team and hope to respond to you as soon as we can.

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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Internal Review of FOI 22/517

Dear Matt Cooper,

Thank you for your email.

Please find attached the response to your Internal Review request.

Kind Regards

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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