Exact quantity of Water for Injection pre and post dilution in BNT162b2

Jonathan Weissman made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

This request has been closed to new correspondence. Contact us if you think it should be reopened.

Jonathan Weissman

Dear Medicines and Healthcare products Regulatory Agency (MHRA),

Given that COMIRNATY has the exact same formulation as Pfizer’s experimental product BNT162b2 [1] deployed in the UK, please answer the following questions with respect to BNT162b2.

Q1. By volume (ml), how much water for injection (UNII: 059QF0KO0R) comprises a single pre-dilution vial in its frozen state?

Q2. Post-dilution, by volume (ml), how much water for injection (UNII: 059QF0KO0R) comprises a single vial?

Q3. By volume (ml), how much water for injection (UNI: 059QF0KO0R) comprises a single post-dilution 0.3ml administered dose?

Q4. Given your answers to the previous three questions, confirm whether your answers are consistent* with both Table 2 (Composition of COMIRNATY Multiple Dose Vial) and Table 3 (Composition of the Diluent) in the FDA’s COMIRNATY document dated 23 August 2021. [2]

Yours faithfully,
Jonathan Weissman BSc MSc MSc
alltherisks.com

*accounting for changes in expanse including ~9% expanse of volume of water at its freezing point, or otherwise [3]

References

[1] Pfizer, "Pfizer and BioNTech initiate rolling submission of supplemental biologics license application to U.S. FDA for booster dose of COMIRNATY® in individuals 16 and older," 25 August 2021. [Online]. Available: https://www.pfizer.com/news/press-releas.... [Accessed 20 October 2021].
[2] "Summary Basis for Regulatory Action (COMIRNATY)," Food and Drug Administration, 23 August 2021. [Online]. Available: https://www.fda.gov/media/151733/download. [Accessed 21 September 2021].
[3] The International Association for the Properties of Water and Steam, "Why does water expand when it freezes? Why does liquid water have a density maximum?," 3 December 2013. [Online]. Available: http://www.iapws.org/faq1/freeze.html. [Accessed 20 October 2021].

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
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• contains offensive language
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• is illegible
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• is for information only 
 
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Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
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For information on how the Agency uses your personal data and your data
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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 #801347 email]> Sent: Wednesday, October 20,
2021 5:55:18 PM To: MHRA Customer Services Subject: Freedom of Information
request - Exact quantity of Water for Injection pre and post dilution in
BNT162b2 Dear Medicines and Healthcare products Regulatory Agency (MHRA),
Given that COMIRNATY has the exact same formulation as Pfizer’s
experimental product BNT162b2 [1] deployed in the UK, please answer the
following questions with respect to BNT162b2. Q1. By volume (ml), how much
water for injection (UNII: 059QF0KO0R) comprises a single pre-dilution
vial in its frozen state? Q2. Post-dilution, by volume (ml), how much
water for injection (UNII: 059QF0KO0R) comprises a single vial? Q3. By
volume (ml), how much water for injection (UNI: 059QF0KO0R) comprises a
single post-dilution 0.3ml administered dose? Q4. Given your answers to
the previous three questions, confirm whether your answers are consistent*
with both Table 2 (Composition of COMIRNATY Multiple Dose Vial) and Table
3 (Composition of the Diluent) in the FDA’s COMIRNATY document dated 23
August 2021. [2] Yours faithfully, Jonathan Weissman BSc MSc MSc
alltherisks.com *accounting for changes in expanse including ~9% expanse
of volume of water at its freezing point, or otherwise [3] References [1]
Pfizer, "Pfizer and BioNTech initiate rolling submission of supplemental
biologics license application to U.S. FDA for booster dose of COMIRNATY®
in individuals 16 and older," 25 August 2021. [Online]. Available:
https://eur01.safelinks.protection.outlo....
[Accessed 20 October 2021]. [2] "Summary Basis for Regulatory Action
(COMIRNATY)," Food and Drug Administration, 23 August 2021. [Online].
Available:
https://eur01.safelinks.protection.outlo....
[Accessed 21 September 2021]. [3] The International Association for the
Properties of Water and Steam, "Why does water expand when it freezes? Why
does liquid water have a density maximum?," 3 December 2013. [Online].
Available:
https://eur01.safelinks.protection.outlo....
[Accessed 20 October 2021].
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/1155

Dear Jonathan Weissman,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 21st October 2021.

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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Jonathan Weissman,

 

Thank you for your email.

 

Regarding your request for information on the quantity of water in
BNT162b2, MHRA neither confirms nor denies that it holds information
falling within the description specified in your request. The duty in
Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not
apply, by virtue of Section 41 (Information provided in confidence) and
Section 43 (Commercial interests) of that Act. This should not be taken as
an indication that the information you requested is or is not held by the
department.

 

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
whereby the information can be used by competitors to inform their own
product development and overcome regulatory hurdles.

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.

 

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 4PU

 

 

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Jonathan Weissman

Dear MHRA Customer Services,

I am writing to immediately request an internal review into my Freedom of Information request.

Water for injection (UNII: 059QF0KO0R) is the only solution listed as an excipient for BNT162b2 by the MHRA. In light of this, the decision to invoke absolute exemption Section 41 and qualified exemption Section 43 to avoid disclosing the exact quantities of water of injection is untenable given my two further below questions.

Q1. Why would the disclosure of the exact amount of water for injection (UNII: 059QF0KO0R) in BNT162b2 inflict any "commercial harm" on Pfizer, as the MHRA claim?

Q2. If the only solution present in BNT162b2 in liquid or frozen state is water for injection (UNII: 059QF0KO0R) then how could confirmation that it comprises the entire solution of BNT162b2 in its pre-dilution and post-dilution state "be used by competitors to inform their own product development and overcome regulatory hurdles"?

If the MHRA somehow believe they can continue to avoid their responsibilities under the FOI Act (2000), please provide a reasonable rationale, starting by fully answering the above two questions.

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 #801347 email]> Sent: Thursday, October 28,
2021 10:51:08 PM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Exact quantity of Water for Injection pre
and post dilution in BNT162b2 Dear MHRA Customer Services, I am writing to
immediately request an internal review into my Freedom of Information
request. Water for injection (UNII: 059QF0KO0R) is the only solution
listed as an excipient for BNT162b2 by the MHRA. In light of this, the
decision to invoke absolute exemption Section 41 and qualified exemption
Section 43 to avoid disclosing the exact quantities of water of injection
is untenable given my two further below questions. Q1. Why would the
disclosure of the exact amount of water for injection (UNII: 059QF0KO0R)
in BNT162b2 inflict any "commercial harm" on Pfizer, as the MHRA claim?
Q2. If the only solution present in BNT162b2 in liquid or frozen state is
water for injection (UNII: 059QF0KO0R) then how could confirmation that it
comprises the entire solution of BNT162b2 in its pre-dilution and
post-dilution state "be used by competitors to inform their own product
development and overcome regulatory hurdles"? If the MHRA somehow believe
they can continue to avoid their responsibilities under the FOI Act
(2000), please provide a reasonable rationale, starting by fully answering
the above two questions. Yours sincerely, Jonathan Weissman -----Original
Message----- Dear Jonathan Weissman, Thank you for your email. Regarding
your request for information on the quantity of water in BNT162b2, MHRA
neither confirms nor denies that it holds information falling within the
description specified in your request. The duty in Section 1(1)(a) of the
Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section
41 (Information provided in confidence) and Section 43 (Commercial
interests) of that Act. This should not be taken as an indication that the
information you requested is or is not held by the department. 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 whereby the information can be used by
competitors to inform their own product development and overcome
regulatory hurdles. 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. 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
4PU -------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #801347 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 21/1155

Dear Jonathan Weissman,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/1155. 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 Service Centre

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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Mr Weissman,

 

Thank you for your reply. We have now completed an Internal Review of FOI
21/1155.

 

As you will see from the redacted composition table attached, water for
injection is used to make up the final volume of the drug product (0.45 ml
total volume in each vial).  The exact amount of water for injection will
take account of any adjustment for the volume of the other components of
the drug product.

 

Furthermore, prior to administration to the recipient, a dilution step
occurs, where 1.8 mL sodium chloride 9 mg/mL (0.9% sodium chloride in
water for injections) solution for injection is added to the vial. 
Therefore, 0.3ml volume of the administered dose is water for injections
containing solutes and the RNA-LNP dispersion.

 

Please let us know if this clarifies the situation.

 

If you remain dissatisfied, you may ask the ICO to make a decision on
whether or not we have interpreted the FOIA correctly in dealing with the
request and subsequent internal review. The ICO’s address is:

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

Kind regards,

 

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

[1]gov.uk/mhra

[2]Stay connected

 

For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: [3]MHRA,
[4]CPRD and [5]NIBSC.

 

 

 

show quoted sections

Dear MHRA Customer Services,

Whilst the attachment of a heavily redacted version of Pfizer’s Section 3.2.P.1 is appreciated, it has not clarified the exact quantity of water for injection in the pre-dilution vial. Given the 7 lower redacted rows of the table, the public currently cannot ascertain whether a proprietary solution comprises another ingredient. It is thus not possible to even approximate the quantity of water for injection indicated by the designation “q.s” given this critical lack of context. This FOI therefore remains unresolved pending the complete disclosure of the entirety of Pfizer’s Section 3.2.P.1.

Please therefore immediately disclose this full section so that the public can understand the exact composition of BNT162b2, allowing them to be sufficiently informed to make vital personal medical decisions. Given its industry-wide use, please likewise also immediately attach Section 3.2.P.1 for the other three COVID-19 vaccines authorised by the MHRA: Moderna, AstraZeneca and Janssen.

Failure to fully disclose Section 3.2.P.1 for the four COVID-19 vaccines would amount to an abject denial of the population’s right to be well informed on critical aspects of unprecedented experimental medical products. This complaint would be immediately escalated to the ICO in such a scenario.

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 #801347 email]> Sent: Monday, November 15,
2021 12:17:52 AM To: MHRA Customer Services Subject: Re: FOI 21/1155
Internal review of Freedom of Information request - Exact quantity of
Water for Injection pre and post dilution in BNT162b2 Dear MHRA Customer
Services, Whilst the attachment of a heavily redacted version of Pfizer’s
Section 3.2.P.1 is appreciated, it has not clarified the exact quantity of
water for injection in the pre-dilution vial. Given the 7 lower redacted
rows of the table, the public currently cannot ascertain whether a
proprietary solution comprises another ingredient. It is thus not possible
to even approximate the quantity of water for injection indicated by the
designation “q.s” given this critical lack of context. This FOI therefore
remains unresolved pending the complete disclosure of the entirety of
Pfizer’s Section 3.2.P.1. Please therefore immediately disclose this full
section so that the public can understand the exact composition of
BNT162b2, allowing them to be sufficiently informed to make vital personal
medical decisions. Given its industry-wide use, please likewise also
immediately attach Section 3.2.P.1 for the other three COVID-19 vaccines
authorised by the MHRA: Moderna, AstraZeneca and Janssen. Failure to fully
disclose Section 3.2.P.1 for the four COVID-19 vaccines would amount to an
abject denial of the population’s right to be well informed on critical
aspects of unprecedented experimental medical products. This complaint
would be immediately escalated to the ICO in such a scenario. Yours
sincerely, Jonathan Weissman -----Original Message----- Dear Mr Weissman,
Thank you for your reply. We have now completed an Internal Review of FOI
21/1155. As you will see from the redacted composition table attached,
water for injection is used to make up the final volume of the drug
product (0.45 ml total volume in each vial). The exact amount of water for
injection will take account of any adjustment for the volume of the other
components of the drug product. Furthermore, prior to administration to
the recipient, a dilution step occurs, where 1.8 mL sodium chloride 9
mg/mL (0.9% sodium chloride in water for injections) solution for
injection is added to the vial. Therefore, 0.3ml volume of the
administered dose is water for injections containing solutes and the
RNA-LNP dispersion. Please let us know if this clarifies the situation. If
you remain dissatisfied, you may ask the ICO to make a decision on whether
or not we have interpreted the FOIA correctly in dealing with the request
and subsequent internal review. The ICO’s address is: The Information
Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF
Kind regards, MHRA Customer Service Centre Medicines and Healthcare
products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14
4PU Telephone 0203 080 6000 [1]gov.uk/mhra [2]Stay connected For
information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: [3]MHRA,
[4]CPRD and [5]NIBSC.
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #801347 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

Our Reference: CSC 75786

Dear Jonathan Weissman,

Thank you for your email.

We have reviewed your enquiry and this has been passed on to our Licensing experts.

Should you have any other questions or requests please feel free to call us on 0203 080 6000 or email at [MHRA request email]

Our opening hours are Mon - Fri 9am to 5pm (excluding UK Public Holidays)
Kind regards,

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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Weissman,

 

The full quantitative composition of each COVID-19 vaccine is exempt under
Section 41* and Section 43* of the FOI Act. The full qualitative
composition is available in section 2 and 6.1 of the SPC of each product.
However, by way of providing reassurance that the qualitative composition
is as stated in SPC, we would also like to mention that companies must
disclose the active substance/s and all excipients as is detailed in the
Human Medicines Regulations 2012.

 

*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
whereby the information can be used by competitors to inform their own
product development and overcome regulatory hurdles.

 

If you remain dissatisfied, you may complain to the ICO. ICO’s address is:

 

The Information Commissioner’s Office

 

Wycliffe House

 

Water Lane

 

Wilmslow

 

Cheshire

 

SK9 5AF

 

 

Kind regards,

 

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

 

 

 

 

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