Quality control of excipients in modRNA Pfizer and Moderna COVID-19 drugs

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.

Dear Medicines and Healthcare Products Regulatory Agency,

According to the EMA's public assessment reports on Pfizer's experimental drug BNT162b2, the following excipients do not comply with quality control standards defined in the European Pharmacopoeia (Ph. Eur.): ALC-0315, ALC-0159 and DSPC.

According to its EPAR, for Moderna's experimental drug mRNA-1273 , the following excipients do not comply with Ph. Eur.: SM-102, DSPC, PEG2000-DMG, tromethamol hydrochloride and sodium acetate trihydrate.

Please disclose documentation on the quality control standards that apply to all of these excipients. The public interest in disclosing such documentation is the right to be sufficiently informed of a medical product prior to consenting to taking it.

Yours faithfully,

Jonathan Weissman BSc MSc MSc
alltherisks.com

[1] https://www.ema.europa.eu/en/documents/a...
[2] https://www.ema.europa.eu/en/documents/a...

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 #833263 email]> Sent: Tuesday, February 15,
2022 12:26:21 AM To: MHRA Customer Services Subject: Freedom of
Information request - Quality control of excipients in modRNA Pfizer and
Moderna COVID-19 drugs Dear Medicines and Healthcare Products Regulatory
Agency, According to the EMA's public assessment reports on Pfizer's
experimental drug BNT162b2, the following excipients do not comply with
quality control standards defined in the European Pharmacopoeia (Ph.
Eur.): ALC-0315, ALC-0159 and DSPC. According to its EPAR, for Moderna's
experimental drug mRNA-1273 , the following excipients do not comply with
Ph. Eur.: SM-102, DSPC, PEG2000-DMG, tromethamol hydrochloride and sodium
acetate trihydrate. Please disclose documentation on the quality control
standards that apply to all of these excipients. The public interest in
disclosing such documentation is the right to be sufficiently informed of
a medical product prior to consenting to taking it. Yours faithfully,
Jonathan Weissman BSc MSc MSc alltherisks.com [1]
https://eur01.safelinks.protection.outlo...
[2]
https://eur01.safelinks.protection.outlo...
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #833263 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 22/476

Dear Jonathan Weissman,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 16th 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

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

2 Attachments

  • Attachment

    RE REplied FOI 22 387 CSC 85448 Freedom of Information request Contamination exact ingredients and WFI GMP for Pfizer s product BNT162b2.txt

    17K Download View as HTML

  • Attachment

    FOI 22 462 Freedom of Information request ALC 0159 purity and tetrahydrofuran contamination in Pfizer s BNT162b2.html

    34K Download

FOI 22/476

Dear Jonathan Weissman,

Thank you for your email.

Details of the finished product specification for the finished product specifications for any of the vaccines or specifications for any of their ingredients, 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.

We note that you have been asking us for the specifications for a lot of parts of the vaccines. Please find attached previous responses as examples.

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

show quoted sections

Dear MHRA Customer Services,

Your reply is acknowledged, but is deemed to be evasive, misleading and unsatisfactory. You are therefore now required to immediately raise this request for an internal review. Confirm the same in the first instance.

In the public interest, I have requested quality control standards that apply to the aforementioned excipients that do not comply with the European Pharmacopeia. In the absence of such disclosure, the public is apparently being asked to trust a "black-box" approach to drug safety. Should the MHRA have any interest in engendering public confidence in the experimental drugs it decides to temporarily authorise, it should disclose such in the first instance. This is the basis for the public interest in disclosing such documentation.

Your evasive attempts to apply unqualified and qualified FOI Act exemptions without providing sufficient details are not credible. Should you wish to again invoke such exceptions, provide a full breakdown of your supposed justification so that it may publicly scrutinised.

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 #833263 email]> Sent: Sunday, February 27,
2022 11:17:10 PM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Quality control of excipients in modRNA
Pfizer and Moderna COVID-19 drugs Dear MHRA Customer Services, Your reply
is acknowledged, but is deemed to be evasive, misleading and
unsatisfactory. You are therefore now required to immediately raise this
request for an internal review. Confirm the same in the first instance. In
the public interest, I have requested quality control standards that apply
to the aforementioned excipients that do not comply with the European
Pharmacopeia. In the absence of such disclosure, the public is apparently
being asked to trust a "black-box" approach to drug safety. Should the
MHRA have any interest in engendering public confidence in the
experimental drugs it decides to temporarily authorise, it should disclose
such in the first instance. This is the basis for the public interest in
disclosing such documentation. Your evasive attempts to apply unqualified
and qualified FOI Act exemptions without providing sufficient details are
not credible. Should you wish to again invoke such exceptions, provide a
full breakdown of your supposed justification so that it may publicly
scrutinised. Yours sincerely, Jonathan Weissman

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 22/476

Dear Jonathan Weissman,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/476. 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 22/476

 

Dear Mr Weissman,

 

Thank you for your email.

 

Please find attached the response to your Internal Review request.

 

Kind Regards

 

 

 

MHRA Customer Experience Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

 

 

show quoted sections