We don't know whether the most recent response to this request contains information or not – if you are Jonathan Weissman please sign in and let everyone know.

Contamination, exact ingredients and WFI GMP for Pfizer's product BNT162b2

Jonathan Weissman 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.

We're waiting for Jonathan Weissman to read a recent response and update the status.

Jonathan Weissman

Dear Medicines and Healthcare Products Regulatory Agency,

With respect to Pfizer’s product BNT162b2 (Comirnaty), please provide the following information.

1. With respect to the list of excipients listed in Section 6.1 of the SmPC for Pfizer/BioNTech [1], confirm which of those excipients are guaranteed to be completely free from graphene contamination (including contamination with graphene oxide). Also, explicitly state a list of those excipients which you CANNOT guarantee to be completely free from contamination by graphene (including contamination with graphene oxide).

*By “completely free from”, I mean that it is theoretically impossible for the excipient to be contaminated with graphene according to the excipient’s manufacturing process, which is known to the MHRA.

2. In addition to the list of excipients provided in Section of the SmPC for Pfizer/BioNTech [1], state a complete list of all ingredients which may appear in the finished drug product, including all ingredients which may occur (in trace amounts or otherwise) in the administered dose as contaminants or residues from the manufacturing process.

3. State the purification methods (e.g., distillation, reverse osmosis or ultra-filtration) used to produce all the water for injections from all parts of the product’s manufacturing process. Confirm whether graphene oxide (or graphene) is used to manufacture any of the water for injections. Confirm whether a reverse osmosis (RO) membrane coated with graphene oxide (or graphene) is used to manufacture any of the water for injections. Provide evidence of the manufacturers’ compliance with the Good Manufacturing Practice (GMP) and Ph. Eur. (0169) [2] for all water for injections used in the manufacturing process.

Now, please answer the above questions with respect to Moderna’s product mRNA-1273 (Spikevax) [3], AstraZeneca’s product ChAdOx1 (Vaxzevria) [4] and Janssen’s product Ad26.COV2.S [5].

Yours faithfully,
Jonathan Weissman BSc MSc MSc
alltherisks.com

[1] https://www.gov.uk/government/publicatio...
[2] https://www.nefro.nl/sites/www.nefro.nl/...
[3] https://www.gov.uk/government/publicatio...
[4] https://www.gov.uk/government/publicatio...
[5] https://www.gov.uk/government/publicatio...

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: Jonathan Weissman
<[FOI #823185 email]> Sent: Tuesday, January 18,
2022 12:08:08 AM To: MHRA Customer Services Subject: Freedom of
Information request - Contamination, exact ingredients and WFI GMP for
Pfizer's product BNT162b2 Dear Medicines and Healthcare Products
Regulatory Agency, With respect to Pfizer’s product BNT162b2 (Comirnaty),
please provide the following information. 1. With respect to the list of
excipients listed in Section 6.1 of the SmPC for Pfizer/BioNTech [1],
confirm which of those excipients are guaranteed to be completely free
from graphene contamination (including contamination with graphene oxide).
Also, explicitly state a list of those excipients which you CANNOT
guarantee to be completely free from contamination by graphene (including
contamination with graphene oxide). *By “completely free from”, I mean
that it is theoretically impossible for the excipient to be contaminated
with graphene according to the excipient’s manufacturing process, which is
known to the MHRA. 2. In addition to the list of excipients provided in
Section of the SmPC for Pfizer/BioNTech [1], state a complete list of all
ingredients which may appear in the finished drug product, including all
ingredients which may occur (in trace amounts or otherwise) in the
administered dose as contaminants or residues from the manufacturing
process. 3. State the purification methods (e.g., distillation, reverse
osmosis or ultra-filtration) used to produce all the water for injections
from all parts of the product’s manufacturing process. Confirm whether
graphene oxide (or graphene) is used to manufacture any of the water for
injections. Confirm whether a reverse osmosis (RO) membrane coated with
graphene oxide (or graphene) is used to manufacture any of the water for
injections. Provide evidence of the manufacturers’ compliance with the
Good Manufacturing Practice (GMP) and Ph. Eur. (0169) [2] for all water
for injections used in the manufacturing process. Now, please answer the
above questions with respect to Moderna’s product mRNA-1273 (Spikevax)
[3], AstraZeneca’s product ChAdOx1 (Vaxzevria) [4] and Janssen’s product
Ad26.COV2.S [5]. Yours faithfully, Jonathan Weissman BSc MSc MSc
alltherisks.com [1]
https://eur01.safelinks.protection.outlo...
[2]
https://eur01.safelinks.protection.outlo...
[3]
https://eur01.safelinks.protection.outlo...
[4]
https://eur01.safelinks.protection.outlo...
[5]
https://eur01.safelinks.protection.outlo...
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #823185 email] Is [MHRA request email] the wrong
address for Freedom of Information requests to Medicines and Healthcare
Products Regulatory Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
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

Our Ref: FOI 22/387

Dear Jonathan Weissman,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 18 January 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 Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 22/387
 
Dear Jonathan Weissman
 
Thank you for your email.
 
As part of the Licensing process, satisfactory certificates of analysis
are provided for all excipients in the finished product to show that they
comply with the agreed specification. Further, methods of manufacture,
batch analyses and specifications are provided to show that the active
substance and finished medicinal product are of suitable quality and
therefore suitable for use. None of the excipients in the Pfizer,
AstraZeneca, Moderna or Janssen vaccines contain graphene oxide.
 
Details of the finished product specification for the finished product,
which contains details of impurities and their control in each of the
authorised vaccines is exempt from release under S41/S43 of the FOI Act.
Details of the manufacturing process is also exempt from release under
S41/S43 of the FOI Act.
 
Section 41 is an absolute exemption and no consideration of the public
interest is required, except to state that we consider its disclosure to
constitute an actionable breach of confidence.
 
Section 43 is a qualified exemption and a consideration of the public
interest should be made. We have considered the public interest and cannot
see any public interest argument that outweighs the commercial harm in
giving manufacturing know-how to competitors who can use this information
to inform the development of their own products.
 
If you have any queries, please reply to this email.
 
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: [1][MHRA request email]
 
Due to the ongoing Covid-19 situation, we are not able to accept delivery
of any documents or correspondence by post or courier to any of our
offices
 
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 Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4P
 
 

show quoted sections

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: Jonathan Weissman
<[FOI #823185 email]> Sent: Tuesday, January 18,
2022 12:08:08 AM To: MHRA Customer Services Subject: REplied - FOI 22/387
CSC 85448 Freedom of Information request - Contamination, exact
ingredients and WFI GMP for Pfizer's product BNT162b2 Dear Medicines and
Healthcare Products Regulatory Agency, With respect to Pfizer’s product
BNT162b2 (Comirnaty), please provide the following information. 1. With
respect to the list of excipients listed in Section 6.1 of the SmPC for
Pfizer/BioNTech [1], confirm which of those excipients are guaranteed to
be completely free from graphene contamination (including contamination
with graphene oxide). Also, explicitly state a list of those excipients
which you CANNOT guarantee to be completely free from contamination by
graphene (including contamination with graphene oxide). *By “completely
free from”, I mean that it is theoretically impossible for the excipient
to be contaminated with graphene according to the excipient’s
manufacturing process, which is known to the MHRA. 2. In addition to the
list of excipients provided in Section of the SmPC for Pfizer/BioNTech
[1], state a complete list of all ingredients which may appear in the
finished drug product, including all ingredients which may occur (in trace
amounts or otherwise) in the administered dose as contaminants or residues
from the manufacturing process. 3. State the purification methods (e.g.,
distillation, reverse osmosis or ultra-filtration) used to produce all the
water for injections from all parts of the product’s manufacturing
process. Confirm whether graphene oxide (or graphene) is used to
manufacture any of the water for injections. Confirm whether a reverse
osmosis (RO) membrane coated with graphene oxide (or graphene) is used to
manufacture any of the water for injections. Provide evidence of the
manufacturers’ compliance with the Good Manufacturing Practice (GMP) and
Ph. Eur. (0169) [2] for all water for injections used in the manufacturing
process. Now, please answer the above questions with respect to Moderna’s
product mRNA-1273 (Spikevax) [3], AstraZeneca’s product ChAdOx1
(Vaxzevria) [4] and Janssen’s product Ad26.COV2.S [5]. Yours faithfully,
Jonathan Weissman BSc MSc MSc alltherisks.com [1]
https://eur01.safelinks.protection.outlo...
[2]
https://eur01.safelinks.protection.outlo...
[3]
https://eur01.safelinks.protection.outlo...
[4]
https://eur01.safelinks.protection.outlo...
[5]
https://eur01.safelinks.protection.outlo...
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #823185 email] Is [MHRA request email] the wrong
address for Freedom of Information requests to Medicines and Healthcare
Products Regulatory Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
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

Jonathan Weissman

Dear MHRA Customer Services,

Whilst I acknowledge receipt of your response, you have failed to address this request in an adequate fashion.

You claim that none of the excipients comprising the COVID-19 experimental drugs (vaccines) contain graphene oxide, but you have failed to confirm that the excipients are free from graphene. You have also provided no documentary evidence to substantiate your claim. Please therefore immediately provide sufficient documentary evidence to substantiate your claim in the first instance.

You are thus required to provide substantive proof that all excipients are free from both graphene oxide and graphene. You must provide documentary evidence that it is not possible that graphene is present in any amount (trace or otherwise) in the excipients and/or the finished drug product. Such evidence must be sufficient to fully exclude the possibility that any of the excipients’ manufacturing processes can theoretically introduce graphene contamination (trace or otherwise) into that excipient and/or the final drug product.

There is significant public interest in learning the exact composition of these experimental drugs given the lack of long-term safety data and the MHRA’s award of the TUAs in an expedited timeframe. Your attempts to protect the commercial interests of multinational pharmaceuticals at the expense of the public’s right to be medically well informed of novel drugs is not credible.

Yours sincerely,

Jonathan Weissman

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: Jonathan Weissman
<[FOI #823185 email]> Sent: Sunday, February 6,
2022 4:25:36 PM To: MHRA Customer Services Subject: RE: REplied - FOI
22/387 CSC 85448 Freedom of Information request - Contamination, exact
ingredients and WFI GMP for Pfizer's product BNT162b2 Dear MHRA Customer
Services, Whilst I acknowledge receipt of your response, you have failed
to address this request in an adequate fashion. You claim that none of the
excipients comprising the COVID-19 experimental drugs (vaccines) contain
graphene oxide, but you have failed to confirm that the excipients are
free from graphene. You have also provided no documentary evidence to
substantiate your claim. Please therefore immediately provide sufficient
documentary evidence to substantiate your claim in the first instance. You
are thus required to provide substantive proof that all excipients are
free from both graphene oxide and graphene. You must provide documentary
evidence that it is not possible that graphene is present in any amount
(trace or otherwise) in the excipients and/or the finished drug product.
Such evidence must be sufficient to fully exclude the possibility that any
of the excipients’ manufacturing processes can theoretically introduce
graphene contamination (trace or otherwise) into that excipient and/or the
final drug product. There is significant public interest in learning the
exact composition of these experimental drugs given the lack of long-term
safety data and the MHRA’s award of the TUAs in an expedited timeframe.
Your attempts to protect the commercial interests of multinational
pharmaceuticals at the expense of the public’s right to be medically well
informed of novel drugs is not credible. Yours sincerely, Jonathan
Weissman -----Original Message----- 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: Jonathan Weissman <[FOI
#823185 email]> Sent: Tuesday, January 18, 2022 12:08:08 AM To: MHRA
Customer Services Subject: REplied - FOI 22/387 CSC 85448 Freedom of
Information request - Contamination, exact ingredients and WFI GMP for
Pfizer's product BNT162b2 Dear Medicines and Healthcare Products
Regulatory Agency, With respect to Pfizer’s product BNT162b2 (Comirnaty),
please provide the following information. 1. With respect to the list of
excipients listed in Section 6.1 of the SmPC for Pfizer/BioNTech [1],
confirm which of those excipients are guaranteed to be completely free
from graphene contamination (including contamination with graphene oxide).
Also, explicitly state a list of those excipients which you CANNOT
guarantee to be completely free from contamination by graphene (including
contamination with graphene oxide). *By “completely free from”, I mean
that it is theoretically impossible for the excipient to be contaminated
with graphene according to the excipient’s manufacturing process, which is
known to the MHRA. 2. In addition to the list of excipients provided in
Section of the SmPC for Pfizer/BioNTech [1], state a complete list of all
ingredients which may appear in the finished drug product, including all
ingredients which may occur (in trace amounts or otherwise) in the
administered dose as contaminants or residues from the manufacturing
process. 3. State the purification methods (e.g., distillation, reverse
osmosis or ultra-filtration) used to produce all the water for injections
from all parts of the product’s manufacturing process. Confirm whether
graphene oxide (or graphene) is used to manufacture any of the water for
injections. Confirm whether a reverse osmosis (RO) membrane coated with
graphene oxide (or graphene) is used to manufacture any of the water for
injections. Provide evidence of the manufacturers’ compliance with the
Good Manufacturing Practice (GMP) and Ph. Eur. (0169) [2] for all water
for injections used in the manufacturing process. Now, please answer the
above questions with respect to Moderna’s product mRNA-1273 (Spikevax)
[3], AstraZeneca’s product ChAdOx1 (Vaxzevria) [4] and Janssen’s product
Ad26.COV2.S [5]. Yours faithfully, Jonathan Weissman BSc MSc MSc
alltherisks.com [1]
https://eur01.safelinks.protection.outlo...
[2]
https://eur01.safelinks.protection.outlo...
[3]
https://eur01.safelinks.protection.outlo...
[4]
https://eur01.safelinks.protection.outlo...
[5]
https://eur01.safelinks.protection.outlo...
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #823185
email] Is [MHRA request email] the wrong address for Freedom of
Information requests to Medicines and Healthcare Products Regulatory
Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #823185 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 MHRA Customer Services,

The response to my request is now delayed. This email is to remind you to answer this request within a timely fashion.

Please ensure that your answer fully accounts not only for the presence of graphene (or graphene oxide or any graphene-related substance) due to contamination, but also accounts for the presence of graphene (or graphene oxide or any graphene-related substance) that may theoretically be present as concomitant components, additives, processing aids, degradants, residual solvents or other components (unredacted starting materials, residual catalysts or metal reagents, reaction by-products, raw material components) in one or more excipients.

Yours sincerely,

Jonathan Weissman

[1] http://www.jpec.gr.jp/document/IPECCompo...

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: Jonathan Weissman
<[FOI #823185 email]> Sent: Saturday, February 19,
2022 1:28:32 AM To: MHRA Customer Services Subject: RE: REplied - FOI
22/387 CSC 85448 Freedom of Information request - Contamination, exact
ingredients and WFI GMP for Pfizer's product BNT162b2 Dear MHRA Customer
Services, The response to my request is now delayed. This email is to
remind you to answer this request within a timely fashion. Please ensure
that your answer fully accounts not only for the presence of graphene (or
graphene oxide or any graphene-related substance) due to contamination,
but also accounts for the presence of graphene (or graphene oxide or any
graphene-related substance) that may theoretically be present as
concomitant components, additives, processing aids, degradants, residual
solvents or other components (unredacted starting materials, residual
catalysts or metal reagents, reaction by-products, raw material
components) in one or more excipients. Yours sincerely, Jonathan Weissman
[1]
https://eur01.safelinks.protection.outlo...
-----Original Message----- 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: Jonathan Weissman <[FOI
#823185 email]> Sent: Sunday, February 6, 2022 4:25:36 PM To: MHRA
Customer Services Subject: RE: REplied - FOI 22/387 CSC 85448 Freedom of
Information request - Contamination, exact ingredients and WFI GMP for
Pfizer's product BNT162b2 Dear MHRA Customer Services, Whilst I
acknowledge receipt of your response, you have failed to address this
request in an adequate fashion. You claim that none of the excipients
comprising the COVID-19 experimental drugs (vaccines) contain graphene
oxide, but you have failed to confirm that the excipients are free from
graphene. You have also provided no documentary evidence to substantiate
your claim. Please therefore immediately provide sufficient documentary
evidence to substantiate your claim in the first instance. You are thus
required to provide substantive proof that all excipients are free from
both graphene oxide and graphene. You must provide documentary evidence
that it is not possible that graphene is present in any amount (trace or
otherwise) in the excipients and/or the finished drug product. Such
evidence must be sufficient to fully exclude the possibility that any of
the excipients’ manufacturing processes can theoretically introduce
graphene contamination (trace or otherwise) into that excipient and/or the
final drug product. There is significant public interest in learning the
exact composition of these experimental drugs given the lack of long-term
safety data and the MHRA’s award of the TUAs in an expedited timeframe.
Your attempts to protect the commercial interests of multinational
pharmaceuticals at the expense of the public’s right to be medically well
informed of novel drugs is not credible. Yours sincerely, Jonathan
Weissman -----Original Message----- 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: Jonathan Weissman <[FOI
#823185 email]> Sent: Tuesday, January 18, 2022 12:08:08 AM To: MHRA
Customer Services Subject: REplied - FOI 22/387 CSC 85448 Freedom of
Information request - Contamination, exact ingredients and WFI GMP for
Pfizer's product BNT162b2 Dear Medicines and Healthcare Products
Regulatory Agency, With respect to Pfizer’s product BNT162b2 (Comirnaty),
please provide the following information. 1. With respect to the list of
excipients listed in Section 6.1 of the SmPC for Pfizer/BioNTech [1],
confirm which of those excipients are guaranteed to be completely free
from graphene contamination (including contamination with graphene oxide).
Also, explicitly state a list of those excipients which you CANNOT
guarantee to be completely free from contamination by graphene (including
contamination with graphene oxide). *By “completely free from”, I mean
that it is theoretically impossible for the excipient to be contaminated
with graphene according to the excipient’s manufacturing process, which is
known to the MHRA. 2. In addition to the list of excipients provided in
Section of the SmPC for Pfizer/BioNTech [1], state a complete list of all
ingredients which may appear in the finished drug product, including all
ingredients which may occur (in trace amounts or otherwise) in the
administered dose as contaminants or residues from the manufacturing
process. 3. State the purification methods (e.g., distillation, reverse
osmosis or ultra-filtration) used to produce all the water for injections
from all parts of the product’s manufacturing process. Confirm whether
graphene oxide (or graphene) is used to manufacture any of the water for
injections. Confirm whether a reverse osmosis (RO) membrane coated with
graphene oxide (or graphene) is used to manufacture any of the water for
injections. Provide evidence of the manufacturers’ compliance with the
Good Manufacturing Practice (GMP) and Ph. Eur. (0169) [2] for all water
for injections used in the manufacturing process. Now, please answer the
above questions with respect to Moderna’s product mRNA-1273 (Spikevax)
[3], AstraZeneca’s product ChAdOx1 (Vaxzevria) [4] and Janssen’s product
Ad26.COV2.S [5]. Yours faithfully, Jonathan Weissman BSc MSc MSc
alltherisks.com [1]
https://eur01.safelinks.protection.outlo...
[2]
https://eur01.safelinks.protection.outlo...
[3]
https://eur01.safelinks.protection.outlo...
[4]
https://eur01.safelinks.protection.outlo...
[5]
https://eur01.safelinks.protection.outlo...
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #823185
email] Is [MHRA request email] the wrong address for Freedom of
Information requests to Medicines and Healthcare Products Regulatory
Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #823185
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #823185 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 MHRA Customer Services,

Given your continued delay in responding adequately, you are now required to immediately raise this freedom of information request for an internal review. Ensure that your response fully accounts for the possibility that graphene (or any graphene-related substance) is present in any amount (trace or otherwise) in one or more excipients as a contaminant or as a concomitant component, additive, processing aid, degradant, residual solvent or other component (unredacted starting material, residual catalyst or metal reagent, reaction by-product, raw material component).

Yours sincerely,

Jonathan Weissman

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: Jonathan Weissman
<[FOI #823185 email]> Sent: Tuesday, February 22,
2022 1:01:36 PM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Contamination, exact ingredients and WFI
GMP for Pfizer's product BNT162b2 Dear MHRA Customer Services, Given your
continued delay in responding adequately, you are now required to
immediately raise this freedom of information request for an internal
review. Ensure that your response fully accounts for the possibility that
graphene (or any graphene-related substance) is present in any amount
(trace or otherwise) in one or more excipients as a contaminant or as a
concomitant component, additive, processing aid, degradant, residual
solvent or other component (unredacted starting material, residual
catalyst or metal reagent, reaction by-product, raw material component).
Yours sincerely, Jonathan Weissman -----Original Message----- 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: Jonathan
Weissman <[FOI #823185 email]> Sent: Saturday, February 19, 2022 1:28:32
AM To: MHRA Customer Services Subject: RE: REplied - FOI 22/387 CSC 85448
Freedom of Information request - Contamination, exact ingredients and WFI
GMP for Pfizer's product BNT162b2 Dear MHRA Customer Services, The
response to my request is now delayed. This email is to remind you to
answer this request within a timely fashion. Please ensure that your
answer fully accounts not only for the presence of graphene (or graphene
oxide or any graphene-related substance) due to contamination, but also
accounts for the presence of graphene (or graphene oxide or any
graphene-related substance) that may theoretically be present as
concomitant components, additives, processing aids, degradants, residual
solvents or other components (unredacted starting materials, residual
catalysts or metal reagents, reaction by-products, raw material
components) in one or more excipients. Yours sincerely, Jonathan Weissman
[1]
https://eur01.safelinks.protection.outlo...
-----Original Message----- 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: Jonathan Weissman <[FOI
#823185 email]> Sent: Sunday, February 6, 2022 4:25:36 PM To: MHRA
Customer Services Subject: RE: REplied - FOI 22/387 CSC 85448 Freedom of
Information request - Contamination, exact ingredients and WFI GMP for
Pfizer's product BNT162b2 Dear MHRA Customer Services, Whilst I
acknowledge receipt of your response, you have failed to address this
request in an adequate fashion. You claim that none of the excipients
comprising the COVID-19 experimental drugs (vaccines) contain graphene
oxide, but you have failed to confirm that the excipients are free from
graphene. You have also provided no documentary evidence to substantiate
your claim. Please therefore immediately provide sufficient documentary
evidence to substantiate your claim in the first instance. You are thus
required to provide substantive proof that all excipients are free from
both graphene oxide and graphene. You must provide documentary evidence
that it is not possible that graphene is present in any amount (trace or
otherwise) in the excipients and/or the finished drug product. Such
evidence must be sufficient to fully exclude the possibility that any of
the excipients’ manufacturing processes can theoretically introduce
graphene contamination (trace or otherwise) into that excipient and/or the
final drug product. There is significant public interest in learning the
exact composition of these experimental drugs given the lack of long-term
safety data and the MHRA’s award of the TUAs in an expedited timeframe.
Your attempts to protect the commercial interests of multinational
pharmaceuticals at the expense of the public’s right to be medically well
informed of novel drugs is not credible. Yours sincerely, Jonathan
Weissman -----Original Message----- 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: Jonathan Weissman <[FOI
#823185 email]> Sent: Tuesday, January 18, 2022 12:08:08 AM To: MHRA
Customer Services Subject: REplied - FOI 22/387 CSC 85448 Freedom of
Information request - Contamination, exact ingredients and WFI GMP for
Pfizer's product BNT162b2 Dear Medicines and Healthcare Products
Regulatory Agency, With respect to Pfizer’s product BNT162b2 (Comirnaty),
please provide the following information. 1. With respect to the list of
excipients listed in Section 6.1 of the SmPC for Pfizer/BioNTech [1],
confirm which of those excipients are guaranteed to be completely free
from graphene contamination (including contamination with graphene oxide).
Also, explicitly state a list of those excipients which you CANNOT
guarantee to be completely free from contamination by graphene (including
contamination with graphene oxide). *By “completely free from”, I mean
that it is theoretically impossible for the excipient to be contaminated
with graphene according to the excipient’s manufacturing process, which is
known to the MHRA. 2. In addition to the list of excipients provided in
Section of the SmPC for Pfizer/BioNTech [1], state a complete list of all
ingredients which may appear in the finished drug product, including all
ingredients which may occur (in trace amounts or otherwise) in the
administered dose as contaminants or residues from the manufacturing
process. 3. State the purification methods (e.g., distillation, reverse
osmosis or ultra-filtration) used to produce all the water for injections
from all parts of the product’s manufacturing process. Confirm whether
graphene oxide (or graphene) is used to manufacture any of the water for
injections. Confirm whether a reverse osmosis (RO) membrane coated with
graphene oxide (or graphene) is used to manufacture any of the water for
injections. Provide evidence of the manufacturers’ compliance with the
Good Manufacturing Practice (GMP) and Ph. Eur. (0169) [2] for all water
for injections used in the manufacturing process. Now, please answer the
above questions with respect to Moderna’s product mRNA-1273 (Spikevax)
[3], AstraZeneca’s product ChAdOx1 (Vaxzevria) [4] and Janssen’s product
Ad26.COV2.S [5]. Yours faithfully, Jonathan Weissman BSc MSc MSc
alltherisks.com [1]
https://eur01.safelinks.protection.outlo...
[2]
https://eur01.safelinks.protection.outlo...
[3]
https://eur01.safelinks.protection.outlo...
[4]
https://eur01.safelinks.protection.outlo...
[5]
https://eur01.safelinks.protection.outlo...
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #823185
email] Is [MHRA request email] the wrong address for Freedom of
Information requests to Medicines and Healthcare Products Regulatory
Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #823185
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #823185
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #823185 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

Dear Jonathan Weissman

Thank you for your email.

As part of the Licensing process, satisfactory certificates of analysis are provided for all excipients in the finished product to show that they comply with the agreed specification. Further, methods of manufacture, batch analyses and specifications are provided to show that the active substance and finished medicinal product are of suitable quality and therefore suitable for use. None of the excipients in the Pfizer, AstraZeneca, Moderna or Janssen vaccines contain graphene.

Details of the finished product specification for the finished product, which contains details of impurities and their control in each of the authorised vaccines is exempt from release under S41/S43 of the FOI Act. Details of the manufacturing process is also exempt from release under S41/S43 of the FOI Act.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in giving manufacturing know-how to competitors who can use this information to inform the development of their own products.

If you have any queries, please reply to this email.

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: [MHRA request email]

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

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 Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4P

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Jonathan Weissman

Thank you for your email.

As part of the Licensing process, satisfactory certificates of analysis are provided for all excipients in the finished product to show that they comply with the agreed specification. Further, methods of manufacture, batch analyses and specifications are provided to show that the active substance and finished medicinal product are of suitable quality and therefore suitable for use. None of the excipients in the Pfizer, AstraZeneca, Moderna or Janssen vaccines contain graphene.

Details of the finished product specification for the finished product, which contains details of impurities and their control in each of the authorised vaccines is exempt from release under S41/S43 of the FOI Act. Details of the manufacturing process is also exempt from release under S41/S43 of the FOI Act.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in giving manufacturing know-how to competitors who can use this information to inform the development of their own products.

If you have any queries, please reply to this email.

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: [MHRA request email]

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

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 Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4P

show quoted sections

Dear MHRA Customer Services,

As per my request, you should now immediately raise this freedom of information request for an internal review. Please confirm the same in the first instance.

Ensure that your response fully accounts for the possibility that graphene (or any graphene-related substance) is present in any amount (trace or otherwise) in one or more excipients as a contaminant or as a concomitant component, additive, processing aid, degradant, residual solvent or other component (unredacted starting material, residual catalyst or metal reagent, reaction by-product, raw material component).

Yours sincerely,

Jonathan Weissman

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: Jonathan Weissman
<[FOI #823185 email]> Sent: Thursday, February 24,
2022 12:07:32 AM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Contamination, exact ingredients and WFI
GMP for Pfizer's product BNT162b2 Dear MHRA Customer Services, As per my
request, you should now immediately raise this freedom of information
request for an internal review. Please confirm the same in the first
instance. Ensure that your response fully accounts for the possibility
that graphene (or any graphene-related substance) is present in any amount
(trace or otherwise) in one or more excipients as a contaminant or as a
concomitant component, additive, processing aid, degradant, residual
solvent or other component (unredacted starting material, residual
catalyst or metal reagent, reaction by-product, raw material component).
Yours sincerely, Jonathan Weissman -----Original Message----- Dear
Jonathan Weissman Thank you for your email. As part of the Licensing
process, satisfactory certificates of analysis are provided for all
excipients in the finished product to show that they comply with the
agreed specification. Further, methods of manufacture, batch analyses and
specifications are provided to show that the active substance and finished
medicinal product are of suitable quality and therefore suitable for use.
None of the excipients in the Pfizer, AstraZeneca, Moderna or Janssen
vaccines contain graphene. Details of the finished product specification
for the finished product, which contains details of impurities and their
control in each of the authorised vaccines is exempt from release under
S41/S43 of the FOI Act. Details of the manufacturing process is also
exempt from release under S41/S43 of the FOI Act. Section 41 is an
absolute exemption and no consideration of the public interest is
required, except to state that we consider its disclosure to constitute an
actionable breach of confidence. Section 43 is a qualified exemption and a
consideration of the public interest should be made. We have considered
the public interest and cannot see any public interest argument that
outweighs the commercial harm in giving manufacturing know-how to
competitors who can use this information to inform the development of
their own products. If you have any queries, please reply to this email.
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: [MHRA request email] Due to the ongoing Covid-19 situation,
we are not able to accept delivery of any documents or correspondence by
post or courier to any of our offices 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 Service Centre Medicines
and Healthcare products Regulatory Agency 10 South Colonnade, Canary
Wharf, London E14 4P
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #823185 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

Jonathan Weissman

Dear MHRA Customer Services,

Your tardiness in confirming that an internal review is being conducted for this request has been noted. Please ensure that you confirm the same in the first instance.

As a gentle reminder, ensure that your response fully accounts for the possibility that graphene (or any graphene-related substance) is present in any amount (trace or otherwise) in one or more excipients as a contaminant or as a concomitant component, additive, processing aid, degradant, residual solvent or other component (unredacted starting material, residual catalyst or metal reagent, reaction by-product, raw material component).

Yours sincerely,

Jonathan Weissman

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: Jonathan Weissman
<[FOI #823185 email]> Sent: Tuesday, March 8, 2022
5:46:42 PM To: MHRA Customer Services Subject: RE: Internal review of
Freedom of Information request - Contamination, exact ingredients and WFI
GMP for Pfizer's product BNT162b2 Dear MHRA Customer Services, Your
tardiness in confirming that an internal review is being conducted for
this request has been noted. Please ensure that you confirm the same in
the first instance. As a gentle reminder, ensure that your response fully
accounts for the possibility that graphene (or any graphene-related
substance) is present in any amount (trace or otherwise) in one or more
excipients as a contaminant or as a concomitant component, additive,
processing aid, degradant, residual solvent or other component (unredacted
starting material, residual catalyst or metal reagent, reaction
by-product, raw material component). Yours sincerely, Jonathan Weissman
-----Original Message----- 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: Jonathan Weissman <[FOI
#823185 email]> Sent: Thursday, February 24, 2022 12:07:32 AM To: MHRA
Customer Services Subject: Internal review of Freedom of Information
request - Contamination, exact ingredients and WFI GMP for Pfizer's
product BNT162b2 Dear MHRA Customer Services, As per my request, you
should now immediately raise this freedom of information request for an
internal review. Please confirm the same in the first instance. Ensure
that your response fully accounts for the possibility that graphene (or
any graphene-related substance) is present in any amount (trace or
otherwise) in one or more excipients as a contaminant or as a concomitant
component, additive, processing aid, degradant, residual solvent or other
component (unredacted starting material, residual catalyst or metal
reagent, reaction by-product, raw material component). Yours sincerely,
Jonathan Weissman -----Original Message----- Dear Jonathan Weissman Thank
you for your email. As part of the Licensing process, satisfactory
certificates of analysis are provided for all excipients in the finished
product to show that they comply with the agreed specification. Further,
methods of manufacture, batch analyses and specifications are provided to
show that the active substance and finished medicinal product are of
suitable quality and therefore suitable for use. None of the excipients in
the Pfizer, AstraZeneca, Moderna or Janssen vaccines contain graphene.
Details of the finished product specification for the finished product,
which contains details of impurities and their control in each of the
authorised vaccines is exempt from release under S41/S43 of the FOI Act.
Details of the manufacturing process is also exempt from release under
S41/S43 of the FOI Act. Section 41 is an absolute exemption and no
consideration of the public interest is required, except to state that we
consider its disclosure to constitute an actionable breach of confidence.
Section 43 is a qualified exemption and a consideration of the public
interest should be made. We have considered the public interest and cannot
see any public interest argument that outweighs the commercial harm in
giving manufacturing know-how to competitors who can use this information
to inform the development of their own products. If you have any queries,
please reply to this email. 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: [MHRA request email] Due to the
ongoing Covid-19 situation, we are not able to accept delivery of any
documents or correspondence by post or courier to any of our offices
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 Service Centre Medicines and Healthcare
products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4P
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #823185
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #823185 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 22/387

Dear Jonathan Weissman,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/387. 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

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Internal Review of FOI 22/387

 

Dear Mr Jonathan Weissman

 

Thank you for your email.

 

Please find attached the reply 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
Telephone 020 3080 6000

 

 

show quoted sections

We don't know whether the most recent response to this request contains information or not – if you are Jonathan Weissman please sign in and let everyone know.