NaOH and HCl Excipients in Pfizer’s SmPC for Comirnaty

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Dear Medicines and Healthcare Products Regulatory Agency,

Recently, both sodium hydroxide and hydrochloric acid have been added to the list of excipients in Section 6.1 of the SmPC for Pifzer’s experimental drug for the purpose of pH-adjustment [1]. Neither excipient is listed in Table 2 of Pfizer’s Summary Basis for Regulatory Action (SBRA) [2].

You are required to comment on this discrepancy and this recent change to the SmPC. In particular, you should now publicly clarify whether this change in the excipient list applies retrospectively or only from the date these two excipients were added to the SmPC.

Disclose all documentation in possession of the MHRA concerning the recent addition of both sodium hydroxide and hydrochloric acid as excipients.

Yours faithfully,

Jonathan Weissman BSc MSc MSc
https://www.alltherisks.com

[1] https://assets.publishing.service.gov.uk...
[2] https://www.fda.gov/media/151733/download

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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________________________________________ From: Jonathan Weissman
<[FOI #835119 email]> Sent: Monday, February 21,
2022 12:41:18 AM To: MHRA Customer Services Subject: Freedom of
Information request - NaOH and HCl Excipients in Pfizer’s SmPC for
Comirnaty Dear Medicines and Healthcare Products Regulatory Agency,
Recently, both sodium hydroxide and hydrochloric acid have been added to
the list of excipients in Section 6.1 of the SmPC for Pifzer’s
experimental drug for the purpose of pH-adjustment [1]. Neither excipient
is listed in Table 2 of Pfizer’s Summary Basis for Regulatory Action
(SBRA) [2]. You are required to comment on this discrepancy and this
recent change to the SmPC. In particular, you should now publicly clarify
whether this change in the excipient list applies retrospectively or only
from the date these two excipients were added to the SmPC. Disclose all
documentation in possession of the MHRA concerning the recent addition of
both sodium hydroxide and hydrochloric acid as excipients. Yours
faithfully, Jonathan Weissman BSc MSc MSc
https://eur01.safelinks.protection.outlo...
[1]
https://eur01.safelinks.protection.outlo...
[2]
https://eur01.safelinks.protection.outlo...
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 23/325

       

Dear Jonathan Weissman,

        

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

Thank you for your enquiry.   

   

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. 

 

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[1]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

 

 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

2 Attachments

FOI 23/325

 

Dear Mr Weissman,

 

Thank you for your request under the Freedom of Information Act, we
apologise for the delay in response.

 

Your request was for information about the COVID-19 Pfizer Vaccine and two
of the excipients: sodium hydroxide and hydrochloric acid. You requested:

 

Disclose all documentation in possession of the MHRA concerning the recent
addition of both sodium hydroxide and hydrochloric acid as excipients.

 

In expectation of being able to provide reassurances in relation to sodium
hydroxide and hydrochloric acid, we have re-approached the Marketing
Authorisation Holder (MAH) in relation to representations on the tables of
quantitative formulae. The MAH have re-considered their position in
relation to these documents which we now release in full, one version
pre-dates the NaOH variation the other was approved in relation to the
NaOH variation (please find both attached).

 

On the topic of the NaOH variation, please be aware that small quantities
of pharmaceutical grade hydrochloric acid and sodium hydroxide are
commonly used to adjust the pH of medicines during manufacture to ensure
that the final pH is suitable for injection (close to the pH which is
found naturally in the body). Hydrochloric acid and sodium chloride have
been added to the list of ingredients because they are used in this way in
the formulation. The excipients in a given pharmaceutical formulation
include ingredients called buffers which keep the pH at a safe level.

 

In relation to the formulation tables, we also wish to mention the
following to avoid any confusion. The number of doses available per vial
changed from 5 to 6 between these two document versions, with no change to
overall content, based on further data & regulatory review (as per MHRA
website details). Please also note, q.s. = quantum satis (as much as may
suffice), this term is commonly used to describe the quantity of
excipients such as water for injection or buffers like sodium hydroxide to
make up the total agreed volume of a medicine or vaccine.

[1]https://www.gov.uk/government/publicatio...

 

“26 January 2021

We have updated the Product Information to state that the vaccine is
manufactured with enough volume for six doses, if our latest guidance for
Healthcare Professionals is followed.

24 December 2020

Updated guidance for Healthcare Professionals on obtaining a sixth dose
from a vial”

Please note, some of the information included in the scope of your request
is exempt under Section 21 of the Freedom of Information (FOI) Act i.e.
that included in the [2]procedural steps document and accompanying public
assessment report on the EMA website for this vaccine. We are exempting
other information covered by the request because it is commercially
sensitive information and so is exempt under S.41 (information provided in
confidence) and S.43 (commercial interests).

 

*Section 41 – is an absolute exemption and no consideration of the public
interest is required, except to state that we would consider the release
of this information to be an actionable breach of confidence.

 

*Section 43 – Release of all, or part of, the information would be likely
to, cause harm to the third party's commercial interests.

We have considered the balance of the public interest when applying this
exemption. The exemption is to safeguard the commercially sensitive
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(which can include a Government Department). This exemption is conditional
on the public interest in releasing it not outweighing the
company's/commercial enterprise's right to confidentiality and the
probable damage that the company/commercial enterprise could suffer as a
result of the information being released. In this case we have not
identified any issues which would benefit the public as a whole by being
brought to their attention (examples of issues would be a major public
health risk or a major procedural failure or irregularity). We have
evaluated the probability of commercial (prejudice) harm to meet the upper
threshold i.e. disclosure of the information ‘would’ cause commercial
harm. This is because the change relates to the manufacturing process and
therefore, product development insights could be obtained by competitors.

 

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Yours sincerely

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

 

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