ALC-0159 purity and tetrahydrofuran contamination in Pfizer's 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,

The European Medicines Agency (EMA) public assessment report (EPAR) on Pfizer’s experimental COVID-19 modRNA drug Comirnaty describes that tetrahydrofuran is included as a solvent in step 2 of the synthesis of PEGylated lipid ALC-0159 [1].

According to the European Chemicals Agency (ECHA), tetrahydrofuran is a suspected carcinogenic agent [2].

Cayman Chemicals, Echelon Biosciences, MedKoo Biosciences and DC Chemicals distribute ALC-0159 at a minimum purity of just 95% [3], [4], [5], [6]. ABP Biosciences distribute it at a minimum purity of 98% [7]. This suggests, potentially, a generous margin of error for impurities in excipient ALC-0159 included in Pfizer’s finished product.

With respect to BNT162b2 (Comirnaty), please provide the following information:
1. Confirm the purity of the excipient ALC-0159.
2. Submit documentary evidence to prove the amount of tetrahydrofuran in the excipient ALC-0159 that is included in BNT162b2 (Comirnaty).

The MHRA recently informed me that “[d]etails 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.” [8]

Should the MHRA attempt to again invoke these FOI Act exemptions, please fully justify why concerns around trade secrets and commercial advantages of a transnational pharmaceutical company outweigh the public’s right to be adequately informed of the extent of contamination with a suspected carcinogenic agent.

Yours faithfully,

Jonathan Weissman BSc MSc MSc
alltherisks.com

[1] https://www.ema.europa.eu/en/documents/a.... pg. 39. Last Updated: 19 February 2021.
[2] https://echa.europa.eu/substance-informa...
[3] https://www.caymanchem.com/product/34336...
[4] https://www.echelon-inc.com/product/alc-...
[5] https://www.medkoo.com/products/47621
[6] https://www.dcchemicals.com/product_show...
[7] https://www.abpbio.com/product/alc-0159/
[8] https://www.whatdotheyknow.com/request/c...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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________________________________________ From: Jonathan Weissman
<[FOI #832385 email]> Sent: Friday, February 11,
2022 12:39:53 AM To: MHRA Customer Services Subject: Freedom of
Information request - ALC-0159 purity and tetrahydrofuran contamination in
Pfizer's BNT162b2 Dear Medicines and Healthcare Products Regulatory
Agency, The European Medicines Agency (EMA) public assessment report
(EPAR) on Pfizer’s experimental COVID-19 modRNA drug Comirnaty describes
that tetrahydrofuran is included as a solvent in step 2 of the synthesis
of PEGylated lipid ALC-0159 [1]. According to the European Chemicals
Agency (ECHA), tetrahydrofuran is a suspected carcinogenic agent [2].
Cayman Chemicals, Echelon Biosciences, MedKoo Biosciences and DC Chemicals
distribute ALC-0159 at a minimum purity of just 95% [3], [4], [5], [6].
ABP Biosciences distribute it at a minimum purity of 98% [7]. This
suggests, potentially, a generous margin of error for impurities in
excipient ALC-0159 included in Pfizer’s finished product. With respect to
BNT162b2 (Comirnaty), please provide the following information: 1. Confirm
the purity of the excipient ALC-0159. 2. Submit documentary evidence to
prove the amount of tetrahydrofuran in the excipient ALC-0159 that is
included in BNT162b2 (Comirnaty). The MHRA recently informed me that
“[d]etails 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.”
[8] Should the MHRA attempt to again invoke these FOI Act exemptions,
please fully justify why concerns around trade secrets and commercial
advantages of a transnational pharmaceutical company outweigh the public’s
right to be adequately informed of the extent of contamination with a
suspected carcinogenic agent. Yours faithfully, Jonathan Weissman BSc MSc
MSc alltherisks.com [1]
https://eur01.safelinks.protection.outlo....
pg. 39. Last Updated: 19 February 2021. [2]
https://eur01.safelinks.protection.outlo...
[3]
https://eur01.safelinks.protection.outlo...
[4]
https://eur01.safelinks.protection.outlo...
[5]
https://eur01.safelinks.protection.outlo...
[6]
https://eur01.safelinks.protection.outlo...
[7]
https://eur01.safelinks.protection.outlo...
[8]
https://eur01.safelinks.protection.outlo...
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/462

Dear Jonathan Weissman,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 11th 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

FOI 22/462

 

Dear Jonathan Weissman,

 

Thank you for your email.

 

This information would be exempt under Section 41 and Section 43 of the
FOI Act. We do not give away commercial secrets concerning the manufacture
and control of any medicinal product or its ingredients. The levels of
ingredients, impurities and degradants are controlled in all authorised
medicinal products so that they are safe. Further, when applying the
public interest test for S43, it should be noted that no evidence of
carcinogens have been found in any of the authorised vaccines to
substantiate the claims you are making.

 

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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

MHRA Customer Services would like to recall the message, "FOI 22/462 - Freedom of Information request - ALC-0159 purity and tetrahydrofuran contamination in Pfizer's BNT162b2".
DISCLAIMER This email and any files transmitted with it are confidential. If you are not the intended recipient, any reading, printing, storage, disclosure, copying or any other action taken in respect of this email is prohibited and may be unlawful. If you are not the intended recipient, please notify the sender immediately by using the reply function and then permanently delete what you have received. Incoming and outgoing email messages are routinely monitored for compliance with the Department of Health's policy on the use of electronic communications. For more information on the Department of Health's email policy, click DHTermsAndConditions<https://www.gov.uk/help/terms-conditions>

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 22/462

 

Dear Jonathan Weissman,

 

Thank you for your email.

 

This information would be exempt under Section 41 and Section 43 of the
FOI Act. We do not give away commercial secrets concerning the manufacture
and control of any medicinal product or its ingredients. The levels of
ingredients, impurities and degradants are controlled in all authorised
medicinal products so that they are safe. Further, when applying the
public interest test for S43, it should be noted that no evidence of
carcinogens have been found in any of the authorised vaccines to
substantiate the claims being made.

 

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 response is acknowledged but is deemed to be evasive, misleading, vexatious and unsatisfactory. As a consequence, you are now required to immediately raise this freedom of information request for internal review.

As one of three excipients in BNT162b2 that does not comply with the European Pharmacopeia [1], you should now provide the exact quality control standards that apply to ALC-0159, besides also providing the same for ALC-0315 and DSPC. The MHRA’s claim that their black-box approach to drug safety should lead to the conclusion that the control of ALC-0159 is “safe” is not credible. The absence of disclosure, to date, of specific quality control standards applying to ALC-0159 is incompatible with the kind of public scrutiny that allows the public to agree with the MHRA’s presently unsubstantiated claim.

In future, please also refrain from issuing vexatious statements such as, “it should be noted that no evidence of carcinogens have been found in any of the authorised vaccines to substantiate the claims you are making.” Your failed attempt to recall your email, prior to rewording this vexatious statement and resending has not gone unnoticed and is documented in the public domain for public scrutiny [2]. As the UK’s medical regulator, you are now required to provide documentation to substantiate your claims on the safety of ALC-0159 and are further advised to not take lightly the designation of a chemical agent as a suspected carcinogen, according to a legitimate body such as the European Chemicals Agency.

The MHRA justified not conducting carcinogenicity studies on BNT162b2 prior to issuing their Regulation 174 temporary approval on the supposed grounds that [3] “vaccine constructs are lipids and RNA that are not expected to have carcinogenic or tumorigenic potential.” In commenting on the carcinogenic potential of tetrahydrofuran in ALC-0159, you should also disclose all internal documentation in possession of the MHRA on this topic.

Yours sincerely,

Jonathan Weissman

[1] https://www.ema.europa.eu/en/documents/a...
[2] https://www.whatdotheyknow.com/request/a...
[3] 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 #832385 email]> Sent: Monday, February 21,
2022 6:16:26 PM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - ALC-0159 purity and tetrahydrofuran
contamination in Pfizer's BNT162b2 Dear MHRA Customer Services, Your
response is acknowledged but is deemed to be evasive, misleading,
vexatious and unsatisfactory. As a consequence, you are now required to
immediately raise this freedom of information request for internal review.
As one of three excipients in BNT162b2 that does not comply with the
European Pharmacopeia [1], you should now provide the exact quality
control standards that apply to ALC-0159, besides also providing the same
for ALC-0315 and DSPC. The MHRA’s claim that their black-box approach to
drug safety should lead to the conclusion that the control of ALC-0159 is
“safe” is not credible. The absence of disclosure, to date, of specific
quality control standards applying to ALC-0159 is incompatible with the
kind of public scrutiny that allows the public to agree with the MHRA’s
presently unsubstantiated claim. In future, please also refrain from
issuing vexatious statements such as, “it should be noted that no evidence
of carcinogens have been found in any of the authorised vaccines to
substantiate the claims you are making.” Your failed attempt to recall
your email, prior to rewording this vexatious statement and resending has
not gone unnoticed and is documented in the public domain for public
scrutiny [2]. As the UK’s medical regulator, you are now required to
provide documentation to substantiate your claims on the safety of
ALC-0159 and are further advised to not take lightly the designation of a
chemical agent as a suspected carcinogen, according to a legitimate body
such as the European Chemicals Agency. The MHRA justified not conducting
carcinogenicity studies on BNT162b2 prior to issuing their Regulation 174
temporary approval on the supposed grounds that [3] “vaccine constructs
are lipids and RNA that are not expected to have carcinogenic or
tumorigenic potential.” In commenting on the carcinogenic potential of
tetrahydrofuran in ALC-0159, you should also disclose all internal
documentation in possession of the MHRA on this topic. Yours sincerely,
Jonathan Weissman [1]
https://eur01.safelinks.protection.outlo...
[2]
https://eur01.safelinks.protection.outlo...
[3]
https://eur01.safelinks.protection.outlo...
-----Original Message----- FOI 22/462 Dear Jonathan Weissman, Thank you
for your email. This information would be exempt under Section 41 and
Section 43 of the FOI Act. We do not give away commercial secrets
concerning the manufacture and control of any medicinal product or its
ingredients. The levels of ingredients, impurities and degradants are
controlled in all authorised medicinal products so that they are safe.
Further, when applying the public interest test for S43, it should be
noted that no evidence of carcinogens have been found in any of the
authorised vaccines to substantiate the claims being made. 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
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #832385 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 22/462

Dear Jonathan Weissman,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/462. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.  

Kind Regards  

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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Internal Review of FOI 22/462

 

Dear Mr Jonathan Weissman,

 

Please find attached the response to your Internal Review Request.

 

Kind Regards

 

 

 

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000

 

show quoted sections