Manufacturing tolerances and Quality Assurance of COVID-19 vaccines

Dear Medicines and Healthcare Products Regulatory Agency,

I would like to request the following documents:

1) Full manufacturing specifications of the contents of all COVID-19 vaccines licenced by MHRA, whether by Section 174 or otherwise, including manufacturing tolerances of the following properties:
a) The concentration of active ingredients
b) The concentration of all excipients, adjuvants and other declared contents. These should be tabulated
c) The maximum permissible concentrations of any possible contaminants, regardless if it is in the manufacturer's documentation. These should be tabulated.

2) Raw analytical data that has been performed on all COVID-19 vaccines licenced by MHRA, whether by Section 174 or otherwise, which demonstrates that the samples tested conform to specification.

Provide the measured values described in 1) a), 1) b) and 1) c) in all datasets provided.

Please provide at least one dataset for each licenced product obtained:
a) During routine batch testing at MHRA/NIBSC.
b) From samples deemed nonconformant elsewhere in the supply chain.

3) Raw data for a sample of a COVID-19 vaccine licenced by MHRA, whether by section 174 or otherwise, which demonstrates that the sample tested did not conform to specification.

Provide the measured values described in 1) a), 1) b) and 1) c) in all datasets provided.

Please provide at least one dataset for each licenced product obtained:
a) During routine batch testing at MHRA/NIBSC
b) From samples deemed nonconformant elsewhere in the supply chain.

For 2) and 3), such data should be in a non-proprietary format (for example .mzML for mass spectrometry data).

4) Laboratory reports and experimental procedures relating to:
a) Pre-distribution batch testing.
b) Analysis of non-conforming samples found post-distribution.

5) For each analytical instrument used in said analysis, provide documentation showing the:
a) Manufacturer.
b) Model and model number.
c) Year of manufacture.
c) Quality documentation that shows that the equipment conformed to specification when it was manufactured and/or commissioned.
d) Raw data or printouts (PDF is acceptable) that demonstrate that the instrument conformed to the specification mentioned in the quality documents described in c).
e) The service schedule specified by the manufacturer.
e) Specifications that the instrument must obtain following a service.
f) Sufficient service records and post-service test data showing that the experimental data in 2) and 3) by the experimental procedure in 4) was produced by an analytical instrument performing in a manner described and specified by the manufacturer.

If this request involves more work than is specified by the cost limit exemption of FOIA, please advise how I can narrow the scope of the request, otherwise I will split this into multiple requests. If the cost limit exemption applies, please advise me of this as soon as possible.

If the quantity of data is unreasonably large to facilitate response by e-mail, other means of data transfer are acceptable.

Yours faithfully,

Matt Cooper

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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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: Matt Cooper
<[FOI #835311 email]> Sent: Monday, February 21,
2022 3:11:36 PM To: MHRA Customer Services Subject: Freedom of Information
request - Manufacturing tolerances and Quality Assurance of COVID-19
vaccines Dear Medicines and Healthcare Products Regulatory Agency, I would
like to request the following documents: 1) Full manufacturing
specifications of the contents of all COVID-19 vaccines licenced by MHRA,
whether by Section 174 or otherwise, including manufacturing tolerances of
the following properties: a) The concentration of active ingredients b)
The concentration of all excipients, adjuvants and other declared
contents. These should be tabulated c) The maximum permissible
concentrations of any possible contaminants, regardless if it is in the
manufacturer's documentation. These should be tabulated. 2) Raw analytical
data that has been performed on all COVID-19 vaccines licenced by MHRA,
whether by Section 174 or otherwise, which demonstrates that the samples
tested conform to specification. Provide the measured values described in
1) a), 1) b) and 1) c) in all datasets provided. Please provide at least
one dataset for each licenced product obtained: a) During routine batch
testing at MHRA/NIBSC. b) From samples deemed nonconformant elsewhere in
the supply chain. 3) Raw data for a sample of a COVID-19 vaccine licenced
by MHRA, whether by section 174 or otherwise, which demonstrates that the
sample tested did not conform to specification. Provide the measured
values described in 1) a), 1) b) and 1) c) in all datasets provided.
Please provide at least one dataset for each licenced product obtained: a)
During routine batch testing at MHRA/NIBSC b) From samples deemed
nonconformant elsewhere in the supply chain. For 2) and 3), such data
should be in a non-proprietary format (for example .mzML for mass
spectrometry data). 4) Laboratory reports and experimental procedures
relating to: a) Pre-distribution batch testing. b) Analysis of
non-conforming samples found post-distribution. 5) For each analytical
instrument used in said analysis, provide documentation showing the: a)
Manufacturer. b) Model and model number. c) Year of manufacture. c)
Quality documentation that shows that the equipment conformed to
specification when it was manufactured and/or commissioned. d) Raw data or
printouts (PDF is acceptable) that demonstrate that the instrument
conformed to the specification mentioned in the quality documents
described in c). e) The service schedule specified by the manufacturer. e)
Specifications that the instrument must obtain following a service. f)
Sufficient service records and post-service test data showing that the
experimental data in 2) and 3) by the experimental procedure in 4) was
produced by an analytical instrument performing in a manner described and
specified by the manufacturer. If this request involves more work than is
specified by the cost limit exemption of FOIA, please advise how I can
narrow the scope of the request, otherwise I will split this into multiple
requests. If the cost limit exemption applies, please advise me of this as
soon as possible. If the quantity of data is unreasonably large to
facilitate response by e-mail, other means of data transfer are
acceptable. Yours faithfully, Matt Cooper
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Please note that in some cases publication of requests and responses will
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/495

Dear Matt Cooper,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 21st 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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 22/495

Dear Matt Cooper,

Thank you for your email.

This information would be exempt under Section 41 and Section 43 of the Freedom of Information Act.

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.

Section 43 is a qualified exemption and a consideration of the public interest is required. We have considered the public interest and cannot see any public interest arguments that outweigh the commercial harm in providing information that can aid a competitor in their product development and help them overcome regulatory hurdles to get their product onto the marketing quicker.

If you have a query about the information provided, please reply to this email.

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

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Dear Medicines and Healthcare Products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare Products Regulatory Agency's handling of my FOI request 'Manufacturing tolerances and Quality Assurance of COVID-19 vaccines'.

Please annotate my original request highlighting which exemptions (including subsections where applicable) were applied and where.

I will remind you that since several elements of the production process for BNT162b2 either are, or have been publicly available through unofficial channels as a result of the EMA data breach, the contract leaks and the ongoing FOI release by the FDA, that some of the information which I have requested does not possess the "necessary quality of confidence".

I would also like to take this opportunity to state that the documentation I have seen so far indicates an mRNA purity of less than 70% in most cases for BNT162b2, and that a significant number of people have seen these documents, one of which has cryptographic proof of identity.
There is public interest in setting the record straight on mRNA purity. We all want to see clear evidence that the manufacturing processes have worked as intended, and that they are made to a high standard.

I would like to request a copy of the public interest assessment you have made, or at least evidence that this assessment actually happened.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/m...

Yours faithfully,

Matt Cooper

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: Matt Cooper
<[FOI #835311 email]> Sent: Tuesday, April 5, 2022
10:25:40 PM To: MHRA Customer Services Subject: Internal review of Freedom
of Information request - Manufacturing tolerances and Quality Assurance of
COVID-19 vaccines Dear Medicines and Healthcare Products Regulatory
Agency, Please pass this on to the person who conducts Freedom of
Information reviews. I am writing to request an internal review of
Medicines and Healthcare Products Regulatory Agency's handling of my FOI
request 'Manufacturing tolerances and Quality Assurance of COVID-19
vaccines'. Please annotate my original request highlighting which
exemptions (including subsections where applicable) were applied and
where. I will remind you that since several elements of the production
process for BNT162b2 either are, or have been publicly available through
unofficial channels as a result of the EMA data breach, the contract leaks
and the ongoing FOI release by the FDA, that some of the information which
I have requested does not possess the "necessary quality of confidence". I
would also like to take this opportunity to state that the documentation I
have seen so far indicates an mRNA purity of less than 70% in most cases
for BNT162b2, and that a significant number of people have seen these
documents, one of which has cryptographic proof of identity. There is
public interest in setting the record straight on mRNA purity. We all want
to see clear evidence that the manufacturing processes have worked as
intended, and that they are made to a high standard. I would like to
request a copy of the public interest assessment you have made, or at
least evidence that this assessment actually happened. A full history of
my FOI request and all correspondence is available on the Internet at this
address:
https://eur01.safelinks.protection.outlo...
Yours faithfully, Matt Cooper
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #835311 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 22/495

Dear Matt Cooper,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/495. 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 22/495

 

Dear Mr Cooper

 

Thank you for your email.

 

Please find attached 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

 

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