Full nucleotide base sequences for all of the COVID vaccines approved by the MRHA

Dr Lee Proctor 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,

Can you kindly provide the full nucleotide base sequence for the mRNA used in both the Pfizer and Moderna COVID vaccines. Can you also provide the full nucleotide base sequence used in the recombinant DNA of the Oxford-AstraZeneca and Johnson and Johnson vaccines.

Yours faithfully,

Dr Lee Proctor

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/813

Dear Dr Lee Proctor

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 14 July 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

FOI 21/813

Dear Dr Lee Proctor,

Thank you for your email.

Regarding your request, dated 14 July 2021, for supporting documentation for full nucleotide base sequence for the mRNA used in both the Pfizer and Moderna COVID vaccines and full nucleotide base sequence used in the recombinant DNA of the Oxford-AstraZeneca and Johnson and Johnson vaccines is exempt under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act.

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 in providing commercial secrets to competitors, who would be able to use this information to aid the development of their own rival product.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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: [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
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SK9 5AF

Yours sincerely

MHRA Customer Service Centre

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

show quoted sections

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 'Full nucleotide base sequences for all of the COVID vaccines approved by the MRHA'.

With the greatest respect I am aware of no authorised pharmaceutical products licensed in the UK for which the chemical structure of the active pharmaceutical ingredient (API) has been wilfully withheld from public disclosure due to the commercial interests of the pharmaceutical innovator. Commercial secrets and harm for any drug product will be comprehensively protected by the pharmaceutical innovator through multiple filings of intellectual property within all international patent jurisdictions. This is standard commercial practice.
The Pfizer and Moderna vaccines are a new class of mRNA vaccines. This type of vaccine has never previously been approved for human use before December 2020 when they received emergency authorisation for inoculation against SARS-CoV-2. The active pharmaceutical ingredient used in these vaccines is a nucleoside-modified mRNA that encodes for the Spike-protein antigen of SARS-CoV-2. These vaccines have been approved for use for any individual aged 16 or older. Most of the UK population is currently being inoculated and Government is mandating vaccination under certain circumstances and introducing an NHS vaccine passport system for certain social settings.
Given the millions of UK citizens who have and are being vaccinated and the measures Government are putting in place to ensure robust compliance then surely it is in the public interest to have complete transparency and for the public to know exactly the chemical structure of the API they are/have been inoculated with. This must surely exceed any commercial interests of the innovator especially when those commercial interests have full intellectual property protection. The chemical structure of the API is the full base sequence of the RNA used in both vaccines.
Similarly, the active pharmaceutical ingredient in the AstraZeneca and Johnson & Johnson vaccines are single recombinant DNA that encodes for the Spike-protein antigen. The DNA for both vaccines must undergo initial transcription within the nucleus of the cells of the recipient where it is transcribed into messenger RNA. The chemical structure of the API is the full base sequence of recombinant DNA.
I politely ask for the information in my original FOI request to be disclosed.

Kind Regards

Dr Lee Proctor

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

Yours faithfully,

Dr Lee Proctor

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,
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The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 21/813

Dear Dr Lee Proctor,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/813. 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

show quoted sections

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 'Full nucleotide base sequences for all of the COVID vaccines approved by the MRHA'.

In addition to my previous communication I also wish to add the following:

The Government are promoting vaccination of the public with RNA and yet the same Government via its Regulatory authority, the MHRA, state the public has no right to know what that RNA is in order to protect the commercial interests of the companies who developed it!!!

This demonstrates a profound lack of transparency.

The RNA is the active pharmaceutical ingredient (API) in the vaccine injection, that means it is the one ingredient that produces the biological response and creates the intended effects. I know of no other examples where the full chemical structure of the API for any drug product is not freely available in the public domain.

I find it incredulous the Government can promote vaccination to all UK citizens aged 16 and older, to mandate vaccination under certain circumstances and to have an NHS vaccine passport system to enable entry to select public places and events and yet the actual chemical substance (the RNA sequence) of the API is being actively withheld from the public’s knowledge in the guise of company confidentiality.

How can any individual give their informed consent to vaccination when the Government refuses to tell them exactly what they are being injected with?

I have requested an internal review of my FOI request

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

Yours faithfully,

Dr Lee Proctor

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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• is illegible
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Medicines and Healthcare products Regulatory Agency
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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. Our [1]guidance and information can be accessed here. 

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Dear Medicines and Healthcare Products Regulatory Agency,

The internal review I requested regarding my FOI request is long overdue. By law, under all circumstances, the authority should of responded by now.

By law, public authorities must respond “promptly” to requests, the law states that they must respond within 20 working days.

Yours faithfully,

Dr Lee Proctor

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: Dr Lee Proctor
<[FOI #773986 email]> Sent: Saturday, September 11,
2021 5:50:35 AM To: MHRA Customer Services Subject: Re: Freedom of
Information request - Full nucleotide base sequences for all of the COVID
vaccines approved by the MRHA Dear Medicines and Healthcare Products
Regulatory Agency, The internal review I requested regarding my FOI
request is long overdue. By law, under all circumstances, the authority
should of responded by now. By law, public authorities must respond
“promptly” to requests, the law states that they must respond within 20
working days. Yours faithfully, Dr Lee Proctor

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Dr Lee Proctor,
 
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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

3 Attachments

Internal Review of FOI 21/813

 

Dear Dr Proctor,

 

Thank you for your email, and your patience whilst we conducted our
internal review.

 

We have obtained consent from the relevant companies to release the full
nucleotide base sequences. Therefore, we attach the nucleotide sequences
of the COVID-19 vaccines Pfizer/BioNTech, COVID‑19 Vaccine AstraZeneca,
and COVID-19 Vaccine Janssen. Please be aware that discussions are
continuing with regard to the release of the sequence of the COVID-19
Vaccine Moderna.

 

 

Kind Regards

 

 

 

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000

 

show quoted sections

Russell Garrett left an annotation ()

The Moderna (and Pfizer/BioNTech) vaccines were sequenced by researchers from discarded vials earlier this year, so you can find the Moderna mRNA sequence in this GitHub repository:

https://github.com/NAalytics/Assemblies-...

Richard Taylor left an annotation ()

The Janssen file released does not contain the nucleotide sequence.

Keith Edkins left an annotation ()

Nucleotide sequence for Pfizer BioNTech as plain text file here:

https://web.archive.org/web/202111021450...

Dear MHRA Customer Services,

First of all thank you for compiling some of the information I requested.

I have reviewed the three documents and confirm my request for the full nucleotide base sequence for both the Pfizer and AstraZeneca vaccines has been disclosed . However the document for the Janssen vaccine does not have the information I requested but instead contains information relating to the genetic sequence of the adenovirus vector (GenBank: EF153474.1) and the amino acid sequence for the protein of the immunogen. Can you kindly provide the full nucleotide base sequence for the dsDNA transgene that encodes for the immunogen because this is the active pharmaceutical ingredient in the Janssen vaccine. By comparison you have provided this information for the Astrazeneca vaccine which is also a replicant-deficient adenovirus vector containing a dsDNA transgene encoding for the immunogen.

I note you are in discussions with Moderna regarding the release of their mRNA nucleotide base sequence.

Thank you once again for the information so far received which is half of that requested. I look forward to receiving the remaining half in due course.

Yours sincerely,

Dr Lee Proctor

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: Dr Lee Proctor
<[FOI #773986 email]> Sent: Tuesday, November 2,
2021 4:31:21 PM To: MHRA Customer Services Subject: Re: Internal Review of
FOI 21/813 - Internal review of Freedom of Information request - Full
nucleotide base sequences for all of the COVID vaccines approved by the
MRHA Dear MHRA Customer Services, First of all thank you for compiling
some of the information I requested. I have reviewed the three documents
and confirm my request for the full nucleotide base sequence for both the
Pfizer and AstraZeneca vaccines has been disclosed . However the document
for the Janssen vaccine does not have the information I requested but
instead contains information relating to the genetic sequence of the
adenovirus vector (GenBank: EF153474.1) and the amino acid sequence for
the protein of the immunogen. Can you kindly provide the full nucleotide
base sequence for the dsDNA transgene that encodes for the immunogen
because this is the active pharmaceutical ingredient in the Janssen
vaccine. By comparison you have provided this information for the
Astrazeneca vaccine which is also a replicant-deficient adenovirus vector
containing a dsDNA transgene encoding for the immunogen. I note you are in
discussions with Moderna regarding the release of their mRNA nucleotide
base sequence. Thank you once again for the information so far received
which is half of that requested. I look forward to receiving the remaining
half in due course. Yours sincerely, Dr Lee Proctor -----Original
Message----- Internal Review of FOI 21/813 Dear Dr Proctor, Thank you for
your email, and your patience whilst we conducted our internal review. We
have obtained consent from the relevant companies to release the full
nucleotide base sequences. Therefore, we attach the nucleotide sequences
of the COVID-19 vaccines Pfizer/BioNTech, COVID‑19 Vaccine AstraZeneca,
and COVID-19 Vaccine Janssen. Please be aware that discussions are
continuing with regard to the release of the sequence of the COVID-19
Vaccine Moderna. Kind Regards MHRA Customer Service Centre Medicines and
Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf,
London E14 4PU Telephone 0203 080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request:
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Reference: CSC 73741

Dear Dr Proctor,

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

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Dr Proctor,

 

Thank you for your reply.

 

We have checked and confirm that the regulatory submission for Janssen
does not contain the transgene nucleotide sequence. There is a full
explanation of the molecular biology for the development of the plasmid,
but the transgene sequence as a stand-alone is not provided.

 

If you require the full transgene sequence, please approach the Company
Janssen:

 

For COVID-19 vaccine information
Tel: 00800 565 4008 8
Tel: 0207 660 2872
E-Mail: [1][email address]
[2]www.covid19vaccinejanssen.com

 

We are yet to have an update in relation to the nucleotide sequence for
the Moderna vaccine.

 

Kind regards,

 

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

[3]gov.uk/mhra

[4]Stay connected

 

For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: [5]MHRA,
[6]CPRD and [7]NIBSC.

 

 

 

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Dr Proctor,

 

Please note we mistakably failed to inform you of the below:

 

If you remain dissatisfied with the result of your internal review, 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

 

From: MHRA Customer Services <[email address]>
Sent: 04 November 2021 11:30
To: Dr Lee Proctor <[FOI #773986 email]>
Subject: CSC 73741 Internal Review of FOI 21/813 - Internal review of
Freedom of Information request - Full nucleotide base sequences for all of
the COVID vaccines approved by the MRHA

 

Dear Dr Proctor,

 

Thank you for your reply.

 

We have checked and confirm that the regulatory submission for Janssen
does not contain the transgene nucleotide sequence. There is a full
explanation of the molecular biology for the development of the plasmid,
but the transgene sequence as a stand-alone is not provided.

 

If you require the full transgene sequence, please approach the Company
Janssen:

 

For COVID-19 vaccine information
Tel: 00800 565 4008 8
Tel: 0207 660 2872
E-Mail: [1][email address]
[2]www.covid19vaccinejanssen.com

 

We are yet to have an update in relation to the nucleotide sequence for
the Moderna vaccine.

 

Kind regards,

 

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

[3]gov.uk/mhra

[4]Stay connected

 

For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: [5]MHRA,
[6]CPRD and [7]NIBSC.

 

 

 

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Dr Proctor,

 

You will hopefully recall our correspondence related to the Internal
Review of FOI 21/813, where we provided you with the nucleotide sequences
for three of the COVID-19 vaccines.

 

Following conclusion of our discussions with Moderna, I am pleased to now
also provide you with the nucleotide sequence for COVID-19 vaccine Moderna
(Spikevax).

 

We trust that this addresses the final part of your original FOI request &
concludes the Internal Review.

 

Many thanks,

 

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.

 

 

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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 'Full nucleotide base sequences for all of the COVID vaccines approved by the MRHA'.

Please accept my sincere thanks for the disclosure of the information received so far.

To date you have responded to my FOI request and have supplied the compete genetic sequence that encodes for the spike protein antigen for the AstraZeneca, Pfizer and Moderna vaccines.

You did supply some information for the Johnson and Johnson (J&J) vaccine but this was not the information requested in my original FOI. When I followed up on this specific enquiry you stated:

"We have checked and confirm that the regulatory submission for Janssen does not contain the transgene nucleotide sequence" and you suggested I contact Johnson and Johnson directly for this information.

As I have stated previously in our correspondence the genetic sequence that encodes for the spike protein antigen is the active pharmaceutical ingredient (API). I am encouraged that AZ, Pfizer and Moderna have included this important information in their submission to the MHRA. This detailed information enables the MHRA to have a complete understanding of the chemical composition of the API to inform their decision to authorise the product, albeit under temporary authorisation under Regulation 174.

I find it somewhat alarming the genetic sequence for the API has not been included in the J&J submission. Without having full disclosure of the API how is it possible for the MHRA to issue a temporary authorisation under Regulation 174 for this medicine?

I am sure this must be a simple oversight or miscommunication. Can I kindly request an internal review be carried out to provide the full genetic sequence for the spike protein antigen in the J&J vaccine? If this information is genuinely not available can you please explain how the MHRA can approve a medicine without having any knowledge regarding the chemical composition of the API in that medicine?

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

Yours faithfully,

Dr Lee Proctor

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: Dr Lee Proctor
<[FOI #773986 email]> Sent: Saturday, December 18,
2021 5:42:11 PM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Full nucleotide base sequences for all of
the COVID vaccines approved by the MRHA 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 'Full nucleotide base sequences for all of the COVID vaccines
approved by the MRHA'. Please accept my sincere thanks for the disclosure
of the information received so far. To date you have responded to my FOI
request and have supplied the compete genetic sequence that encodes for
the spike protein antigen for the AstraZeneca, Pfizer and Moderna
vaccines. You did supply some information for the Johnson and Johnson
(J&J) vaccine but this was not the information requested in my original
FOI. When I followed up on this specific enquiry you stated: "We have
checked and confirm that the regulatory submission for Janssen does not
contain the transgene nucleotide sequence" and you suggested I contact
Johnson and Johnson directly for this information. As I have stated
previously in our correspondence the genetic sequence that encodes for the
spike protein antigen is the active pharmaceutical ingredient (API). I am
encouraged that AZ, Pfizer and Moderna have included this important
information in their submission to the MHRA. This detailed information
enables the MHRA to have a complete understanding of the chemical
composition of the API to inform their decision to authorise the product,
albeit under temporary authorisation under Regulation 174. I find it
somewhat alarming the genetic sequence for the API has not been included
in the J&J submission. Without having full disclosure of the API how is it
possible for the MHRA to issue a temporary authorisation under Regulation
174 for this medicine? I am sure this must be a simple oversight or
miscommunication. Can I kindly request an internal review be carried out
to provide the full genetic sequence for the spike protein antigen in the
J&J vaccine? If this information is genuinely not available can you please
explain how the MHRA can approve a medicine without having any knowledge
regarding the chemical composition of the API in that medicine? 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, Dr Lee Proctor
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #773986 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
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Reference: CSC 81150

Dear Dr Proctor,

Thank you for your email.

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

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Telephone 0203 080 6000
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Dr Proctor,

 

As mentioned in our reply to another of your requests, we have recently
been considering our response and internal review of (21/813).

 

We have been in contact with Janssen, and we have received representations
on confidentiality grounds from them. However, in reply we have asked a
number of further questions and we are currently awaiting their response.

 

We expect a short delay whilst we await their response, however, we will
also need further time to consider those responses once received. We are
aware that the standard deadline within which to conduct an internal
review has surpassed, however, the ICO does allow for extensions for
complex internal review cases.

 

I understand that another of your requests for internal reviews was
concluded on April 1^st [ ]but please do let us know if you have not
received this.  

 

Many thanks for your patience,

 

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

Our Ref: FOI 21/813

       

Dear Dr Proctor,

       

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

Thank you for your email.

 

We have reviewed the company’s representations and are now in the process
of drafting the internal review.

 

We aim to respond by 6 May 2022.

 

 

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

 

 

 

 

 

DISCLAIMER This email and any files transmitted with it are confidential.
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Our Ref: FOI 21/813

       

Dear Dr Proctor,

       

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

Thank you for your email.

 

Please find attached internal review response.

 

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

 

 

From: MHRA Customer Services <[email address]>
Sent: 03 May 2022 13:22
To: [FOI #773986 email]
Subject: FW: Nucleotide sequence Moderna vaccine FOI 21/813

 

Our Ref: FOI 21/813

       

Dear Dr Proctor,

       

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

Thank you for your email.

 

We have reviewed the company’s representations and are now in the process
of drafting the internal review.

 

We aim to respond by 6 May 2022.

 

 

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

 

 

 

 

 

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
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Dear MHRA Customer Services,

Thank you for taking the time to complete an Internal Review for FOI 21 813.

The reasoning and arguments given in the Internal Review to uphold use of Sections 41 and 43(1) and (2) in line with a perceived greater risk of commercial harm vs. public interest are somewhat perplexing. All arguments presented in the Internal review with respect to commercial harm and public interest are completely undermined by the fact the MHRA disclosed the requested information for the Pfizer/BioNTech, Moderna and AstraZeneca vaccines.

This begs the question of how a commercial harm and public interest argument can be made for one company and product (Janssen / Jcovden) but not for three alternative companies and their equivalent products? This clearly demonstrates inconsistencies by the MHRA or a policy change within the MHRA to be open and transparent to the UK public regarding the medicines and products they regulate!

Yours sincerely,

Dr Lee Proctor

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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________________________________________ From: Dr Lee Proctor
<[FOI #773986 email]> Sent: Monday, May 16, 2022
8:04:12 AM To: MHRA Customer Services Subject: RE: Nucleotide sequence
Moderna vaccine FOI 21/813 Dear MHRA Customer Services, Thank you for
taking the time to complete an Internal Review for FOI 21 813. The
reasoning and arguments given in the Internal Review to uphold use of
Sections 41 and 43(1) and (2) in line with a perceived greater risk of
commercial harm vs. public interest are somewhat perplexing. All arguments
presented in the Internal review with respect to commercial harm and
public interest are completely undermined by the fact the MHRA disclosed
the requested information for the Pfizer/BioNTech, Moderna and AstraZeneca
vaccines. This begs the question of how a commercial harm and public
interest argument can be made for one company and product (Janssen /
Jcovden) but not for three alternative companies and their equivalent
products? This clearly demonstrates inconsistencies by the MHRA or a
policy change within the MHRA to be open and transparent to the UK public
regarding the medicines and products they regulate! Yours sincerely, Dr
Lee Proctor -----Original Message----- Our Ref: FOI 21/813 Dear Dr
Proctor, RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000 Thank you
for your email. Please find attached internal review response. 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 From: MHRA
Customer Services <[email address]> Sent: 03 May 2022 13:22 To: [FOI
#773986 email] Subject: FW: Nucleotide sequence Moderna vaccine FOI 21/813
Our Ref: FOI 21/813 Dear Dr Proctor, RE: REQUEST UNDER THE FREEDOM OF
INFORMATION ACT 2000 Thank you for your email. We have reviewed the
company’s representations and are now in the process of drafting the
internal review. We aim to respond by 6 May 2022. 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 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
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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 [1]DHTermsAndConditions References Visible
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

CSC 100418

Dear Dr Proctor,

Thank you for your swift reply, we acknowledge that to withhold a portion of the Janssen sequence, when offering full disclosure for the Pfizer/BioNTech, Moderna and AstraZeneca vaccines can appear to represent an inconsistent approach. However, Janssen had outlined a clear routes to commercial harm that would be encountered if the document in question was to be released, and they also did not waive our duty of confidence. As mentioned, in the review we could revisit the public interest arguments (S.41 and S.43) if a compelling case was made for the benefit/s that the release of this portion of the sequence is would deliver, is (are) made known.

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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