Lipid-related impurity issues for 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.

Dear Medicines and Healthcare Products Regulatory Agency,

According to the MHRA's public assessment report of Pfizer's experimental drug BNT162b2, in commenting on lipid-related impurities, "No critical issues have been identified with respect to the lipids that would preclude the emergency use of the vaccine." [1]

Please address the below with respect to BNT162b2.

1. Provide all documentation in possession of the MHRA fully covering all lipid-related impurity issues. In particular, provide an exhaustive list of all (known) lipid-related impurity issues relating to cholesterol (with respect to Ph. Eur. or otherwise) and ALC-0159, ALC-0315 and DSPC, where the applicant has defined and/or provided the quality control standards for the impurity control strategy or otherwise. Include all such issues regardless of severity.

2. Now clarify the MHRA's sentence quoted verbatim above. In particular, you should confirm whether any "critical issues" were identified with respect to lipid impurity control prior to the public assessment report. Note: "critical issues" exist irrespective of whether the MHRA judge such an issue to "preclude emergency use of the vaccine."

Yours faithfully,

Jonathan Weissman BSc MSc MSc
alltherisks.com

[1] 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 #834758 email]> Sent: Friday, February 18,
2022 11:50:52 PM To: MHRA Customer Services Subject: Freedom of
Information request - Lipid-related impurity issues for BNT162b2 Dear
Medicines and Healthcare Products Regulatory Agency, According to the
MHRA's public assessment report of Pfizer's experimental drug BNT162b2, in
commenting on lipid-related impurities, "No critical issues have been
identified with respect to the lipids that would preclude the emergency
use of the vaccine." [1] Please address the below with respect to
BNT162b2. 1. Provide all documentation in possession of the MHRA fully
covering all lipid-related impurity issues. In particular, provide an
exhaustive list of all (known) lipid-related impurity issues relating to
cholesterol (with respect to Ph. Eur. or otherwise) and ALC-0159, ALC-0315
and DSPC, where the applicant has defined and/or provided the quality
control standards for the impurity control strategy or otherwise. Include
all such issues regardless of severity. 2. Now clarify the MHRA's sentence
quoted verbatim above. In particular, you should confirm whether any
"critical issues" were identified with respect to lipid impurity control
prior to the public assessment report. Note: "critical issues" exist
irrespective of whether the MHRA judge such an issue to "preclude
emergency use of the vaccine." Yours faithfully, Jonathan Weissman BSc MSc
MSc alltherisks.com [1]
https://eur01.safelinks.protection.outlo...
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #834758 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

4 Attachments

  • Attachment

    Freedom of Information request Important protocol deviations within 7 days after Dose 2 in BNT162b2 clinical trial.txt

    4K Download View as HTML

  • Attachment

    Freedom of Information request Weight of water for injection in BNT162b2.txt

    7K Download View as HTML

  • Attachment

    Freedom of Information request NaOH and HCl Excipients in Pfizer s SmPC for Comirnaty.txt

    4K Download View as HTML

  • Attachment

    Freedom of Information request Exact definitions of PF 07305885 and PF 07302048 in BNT162b2.txt

    4K Download View as HTML

FOI 22/549

Dear Mr Jonathan Weissman,

Thank you for your emails of 21 February and we have attached the emails and included email below for ease of reference.

We have received a total of 10 requests from you and have been responding to you as quickly and as informatively as we can. However, in the last month we have received from you 5 requests which we are amalgamating and treating under FOI 22/549.

The Freedom of Information Act places a general duty on public authorities to give access to official information. However, the Act also provides an exemption to that duty under Section 14 (1) where a public authority considers the request to be vexatious. The Information Commissioner’s Office provides guidance on how to interpret this exemption, and one of the criteria to consider is that of frequent and overlapping requests. We judge that your combined requests fall into this category and as such we are refusing under Section 14 (1).

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 note that we regularly update our website with information regarding COVID-19 and our work in this area:
https://eur01.safelinks.protection.outlo...

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

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

show quoted sections

Jonathan Weissman

Dear MHRA Customer Services,

Your email is acknowledged but is deemed to be inaccurate and disingenuous.

The MHRA has had previous opportunities to indicate they could not receive any further requests of mine, but has never indicated an apparently unsustainable workload until now. Furthermore, under the FOI Act (2000), there is no absolute limit on the number of requests that may be issued by a member of the public.

Given both the MHRA's unprecedented temporary approval of experimental drugs such as Pfizer's BNT162b2/Comirnaty and ongoing legal challenges both domestically and internationally, public interest in the kind of information I've been requesting should be expected. Tenuous attempts to avoid disclosing such information by invoking Section 14 (1) should be made only after fully reflecting on the ICO's guide [1]. I refer you to points 98-108, in particular.

The claim that the MHRA "have been responding... as quickly and as informatively as we can" is not credible. To date, there is no evidence of any work having been conducted by the MHRA on any of the 5 amalgamated requests that could substantiate such a claim. Kindly disclose evidence to the contrary should it exist. Such a claim only seeks to yet further raise concerns around the professional conduct and impartiality of the MHRA.

You should now immediately conduct an internal review on this and confirm the same in the first instance.

Yours sincerely,

Jonathan Weissman

[1] https://ico.org.uk/media/for-organisatio...

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 #834758 email]> Sent: Thursday, March 17,
2022 3:48:01 PM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Lipid-related impurity issues for
BNT162b2 Dear MHRA Customer Services, Your email is acknowledged but is
deemed to be inaccurate and disingenuous. The MHRA has had previous
opportunities to indicate they could not receive any further requests of
mine, but has never indicated an apparently unsustainable workload until
now. Furthermore, under the FOI Act (2000), there is no absolute limit on
the number of requests that may be issued by a member of the public. Given
both the MHRA's unprecedented temporary approval of experimental drugs
such as Pfizer's BNT162b2/Comirnaty and ongoing legal challenges both
domestically and internationally, public interest in the kind of
information I've been requesting should be expected. Tenuous attempts to
avoid disclosing such information by invoking Section 14 (1) should be
made only after fully reflecting on the ICO's guide [1]. I refer you to
points 98-108, in particular. The claim that the MHRA "have been
responding... as quickly and as informatively as we can" is not credible.
To date, there is no evidence of any work having been conducted by the
MHRA on any of the 5 amalgamated requests that could substantiate such a
claim. Kindly disclose evidence to the contrary should it exist. Such a
claim only seeks to yet further raise concerns around the professional
conduct and impartiality of the MHRA. You should now immediately conduct
an internal review on this and confirm the same in the first instance.
Yours sincerely, Jonathan Weissman [1]
https://eur01.safelinks.protection.outlo...
-----Original Message----- FOI 22/549 Dear Mr Jonathan Weissman, Thank you
for your emails of 21 February and we have attached the emails and
included email below for ease of reference. We have received a total of 10
requests from you and have been responding to you as quickly and as
informatively as we can. However, in the last month we have received from
you 5 requests which we are amalgamating and treating under FOI 22/549.
The Freedom of Information Act places a general duty on public authorities
to give access to official information. However, the Act also provides an
exemption to that duty under Section 14 (1) where a public authority
considers the request to be vexatious. The Information Commissioner’s
Office provides guidance on how to interpret this exemption, and one of
the criteria to consider is that of frequent and overlapping requests. We
judge that your combined requests fall into this category and as such we
are refusing under Section 14 (1). 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 note that we regularly update our website with
information regarding COVID-19 and our work in this area:
https://eur01.safelinks.protection.outlo...
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 Medicines and Healthcare
products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14
4PU -------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #834758 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 22/549

Dear Jonathan Weissman,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/549. 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

Dear Jonathan Weissman,

Thank you for your email.

Please find attached the response to your internal review.

Kind Regards,

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

show quoted sections