Independent analytical analysis of COVID-19 vaccines
Dear Medicines and Healthcare Products Regulatory Agency,
1) Has independent analytical analysis been performed on any of the COVID-19 vaccines in use in the UK in order to verify the products only contain what is listed?
-If 1) has not been done, can you ensure this is included in any licensing documentation?
-If 1) has been done, I would like the following:
2) What analytical methods were used?
3) What make and model of analytical instrument(s) were used?
4) What was the experimental technique? Provide documentary evidence.
5) Provide the raw data from these analyses in a non-propriatary format (for example .xls(x) and/or .mz(X)ML). mzML is preferred for any mass spectra.
If data transfer is problematic, I am happy to accept a USB stick in the post at my own expense as long as reasonable effort has been made to minimise redundant data.
Yours faithfully,
Matt Cooper
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References
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Our Ref: FOI 21/887
Dear Matt Cooper,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 2 August 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
Dear Matt Cooper,
Thank you for your email.
All laboratories used in the testing of all authorised vaccines have to
provide certificates to show that they work in compliance with Good
Manufacturing Practice for quality testing, and have to provide proof of a
recent inspection by a mutually recognised medicines authority.
Regarding your questions 2-5, unfortunately, the information is exempt
from release. 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.
Examples of public interest arguments would be a major public health risk
or a major procedural failure or irregularity.
If you have a query about the information provided, please reply to this
email
If you are dissatisfied with the handling of your request, you have the
right to ask for an internal review. Internal review requests should be
submitted within two months of the date you receive this response and
addressed to: [1][MHRA request email]
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
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 'Independent analytical analysis of COVID-19 vaccines'.
Regarding the following claims made in the response to this FOI:
"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."
From the ICO's guidance on Section 41, available at the following address:
https://ico.org.uk/media/for-organisatio...
One of the qualifiers for exemption is the following:
"
Information will possess the necessary quality of confidence if;
- it is more than trivial; and
- not otherwise accessible.
"
Since Pfizer's supply contracts spanning two continents have been leaked, one is cryptographically signed as genuine and these are available at the following address:
https://senseofawareness.com/2021/07/29/...
The genetic code for the mRNA used by Pfizer is available at the following address:
https://berthub.eu/articles/11889.doc
Since there are several clauses in these contracts which relate strongly to confidentiality, I can understand why this exemption was attempted. However, it can be argued that both:
- A contract indemifying a manufacturer for a product that has been linked to hundreds of fatal adverse reactions according to MHRA's own Yellow Card system is more than trivial.
- Since contracts spanning multiple continents only appear to differ in the price paid per dose, it is highly unlikely that the UK negotiated any significant change in the contract.
The latter statement breaks the second limb of the "necessary quality of confidence" which Section 41 requires. The first statement is a clear argument for not invoking Section 43.
"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.
Examples of public interest arguments would be a major public health risk
or a major procedural failure or irregularity."
- There is an ongoing major public health risk, otherwise why would Section 174 of the Human Medicines Regulations be considered?
- There are over a thousand fatal ADRs published on your own Yellow Card system, which you have verified to be correct.
- There have been several contamination issues of a very serious nature related to COVID-19 vaccine manufacture. These include breaches of cGMP.
- Pfizer has a known track record of paying fines for criminal misconduct relating to its own products.
Please release records of the consideration of public interest made before choosing to invoke Section 43.
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/i...
Yours faithfully,
Matt Cooper
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 #778347 email]> Sent: Monday, September 20,
2021 7:18:54 AM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Independent analytical analysis 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 'Independent analytical analysis of COVID-19 vaccines'. Regarding
the following claims made in the response to this FOI: "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." From the ICO's guidance on Section 41,
available at the following address:
https://urldefense.proofpoint.com/v2/url...
One of the qualifiers for exemption is the following: " Information will
possess the necessary quality of confidence if; - it is more than trivial;
and - not otherwise accessible. " Since Pfizer's supply contracts spanning
two continents have been leaked, one is cryptographically signed as
genuine and these are available at the following address:
https://urldefense.proofpoint.com/v2/url...
The genetic code for the mRNA used by Pfizer is available at the following
address:
https://urldefense.proofpoint.com/v2/url...
Since there are several clauses in these contracts which relate strongly
to confidentiality, I can understand why this exemption was attempted.
However, it can be argued that both: - A contract indemifying a
manufacturer for a product that has been linked to hundreds of fatal
adverse reactions according to MHRA's own Yellow Card system is more than
trivial. - Since contracts spanning multiple continents only appear to
differ in the price paid per dose, it is highly unlikely that the UK
negotiated any significant change in the contract. The latter statement
breaks the second limb of the "necessary quality of confidence" which
Section 41 requires. The first statement is a clear argument for not
invoking Section 43. "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. Examples of public interest arguments would
be a major public health risk or a major procedural failure or
irregularity." - There is an ongoing major public health risk, otherwise
why would Section 174 of the Human Medicines Regulations be considered? -
There are over a thousand fatal ADRs published on your own Yellow Card
system, which you have verified to be correct. - There have been several
contamination issues of a very serious nature related to COVID-19 vaccine
manufacture. These include breaches of cGMP. - Pfizer has a known track
record of paying fines for criminal misconduct relating to its own
products. Please release records of the consideration of public interest
made before choosing to invoke Section 43. A full history of my FOI
request and all correspondence is available on the Internet at this
address:
https://urldefense.proofpoint.com/v2/url...
Yours faithfully, Matt Cooper
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #778347 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://urldefense.proofpoint.com/v2/url...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://urldefense.proofpoint.com/v2/url...
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.
Internal Review of FOI 21/887
Dear Matt Cooper,
Thank you for your email.
We confirm that an internal review will be carried out on FOI 21/887. 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
Dear MHRA Customer Services,
If I do not receive an acceptable response before 1 December 2021, this request will be referred directly to the ICO, as MHRA has, on multiple occasions misused the FOIA, used "canned replies" and in some cases outright lied in responses to reasonable requests made under FOIA, some of which would place MHRA in breach of its own supply contract for COVID-19 Vaccine AstraZeneca, as pharmacovigilance is listed as grounds for liability.
Assume in any future communications that I have read the supply contracts for these vaccines.
Yours sincerely,
Matt Cooper
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 #778347 email]> Sent: Saturday, October 30,
2021 2:39:36 PM To: MHRA Customer Services Subject: Re: FOI 21/887
Internal review of Freedom of Information request - Independent analytical
analysis of COVID-19 vaccines Dear MHRA Customer Services, If I do not
receive an acceptable response before 1 December 2021, this request will
be referred directly to the ICO, as MHRA has, on multiple occasions
misused the FOIA, used "canned replies" and in some cases outright lied in
responses to reasonable requests made under FOIA, some of which would
place MHRA in breach of its own supply contract for COVID-19 Vaccine
AstraZeneca, as pharmacovigilance is listed as grounds for liability.
Assume in any future communications that I have read the supply contracts
for these vaccines. Yours sincerely, Matt Cooper -----Original
Message----- Internal Review of FOI 21/887 Dear Matt Cooper, Thank you for
your email. We confirm that an internal review will be carried out on FOI
21/887. 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
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #778347 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.
Dear Matt Cooper,
Thank you for your email.
We have chased your enquiry with our Licensing experts and we can only apologise that you have not yet received a response. We have notified the team concerned and they will respond to you as soon as they can.
We are sorry for the length of time you have to wait for a response.
In the meantime should you require any further advice or assistance on this matter please feel free to call us on 020 3080 6000 or reply to this email.
Our opening hours are Mon - Fri 9am to 5pm (excluding UK Public Holidays)
With regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear Matt Cooper,
Thank you for your email.
Please find attached our internal review.
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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