Nuvaxovid pharmacokinetics

Graham Crawley made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

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Dear Medicines and Healthcare Products Regulatory Agency,

Regarding the recombinant protein nanoparticle vaccine Nuvaxovid
Please supply the following information
1. What is the elimination half-life (or estimate thereof) of the protein nanoparticle in humans following an intramuscular injection of Nuvaxovid?
2. Please provide a concentration profile over 24 hours (or longer) of protein nanoparticle in whole blood or plasma following intramuscular injection of Nuvaxovid
3. Please provide what data you have of the biodistribution in animals of the protein nanoparticle following intramuscular injection?

Yours faithfully,

Graham Crawley

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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London 
E14 4PU
gov.uk/mhra
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________________________________________ From: Graham Crawley
<[FOI #830477 email]> Sent: Saturday, February 5,
2022 3:55:57 PM To: MHRA Customer Services Subject: Freedom of Information
request - Nuvaxovid pharmacokinetics Dear Medicines and Healthcare
Products Regulatory Agency, Regarding the recombinant protein nanoparticle
vaccine Nuvaxovid Please supply the following information 1. What is the
elimination half-life (or estimate thereof) of the protein nanoparticle in
humans following an intramuscular injection of Nuvaxovid? 2. Please
provide a concentration profile over 24 hours (or longer) of protein
nanoparticle in whole blood or plasma following intramuscular injection of
Nuvaxovid 3. Please provide what data you have of the biodistribution in
animals of the protein nanoparticle following intramuscular injection?
Yours faithfully, Graham Crawley
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/451

Dear Graham Crawley,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 3rd 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 22/451

Dear Graham Crawley,

Thank you for your email.

As we plan to publish the public assessment report within the next 60 calendar days, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure. Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld.

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.

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,
re FOI 22/451
As the MHRA has authorised Nuvaxovid I regard it is in the public interest to disclose these information now, not in 60 days' time. I am requesting an internal review

Yours faithfully,

Graham Crawley

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: Graham Crawley
<[FOI #830477 email]> Sent: Saturday, March 5, 2022
2:47:46 PM To: MHRA Customer Services Subject: Internal review of Freedom
of Information request - Nuvaxovid pharmacokinetics Dear Medicines and
Healthcare Products Regulatory Agency, re FOI 22/451 As the MHRA has
authorised Nuvaxovid I regard it is in the public interest to disclose
these information now, not in 60 days' time. I am requesting an internal
review Yours faithfully, Graham Crawley
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #830477 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 22/451

Dear Graham Crawley,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/451. 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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Dear MHRA Customer Services,
Please tell me when you expect to respond to this request
Internal Review of FOI 22/451

Yours sincerely,

Graham Crawley

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: Graham Crawley
<[FOI #830477 email]> Sent: Tuesday, April 5, 2022
11:57:17 AM To: MHRA Customer Services Subject: Internal review of Freedom
of Information request - Nuvaxovid pharmacokinetics Dear MHRA Customer
Services, Please tell me when you expect to respond to this request
Internal Review of FOI 22/451 Yours sincerely, Graham Crawley
-----Original Message----- Internal Review of FOI 22/451 Dear Graham
Crawley, Thank you for your email. We confirm that an internal review will
be carried out on FOI 22/451. 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
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #830477 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 22/451

Dear Graham Crawley,

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

We do not think the public interest is heightened to such a degree as to warrant expediting the production of this particular public assessment report. Our team are making their best efforts to draft and publish according to our standard timelines.
The use of Section 22 of the FOIA is in line with the ICO guidance on use of the Section - the timeline for publication was included in the original response.

However, in the interest of time, please find our response to your specific questions below:

Q1 and 2: No pharmacokinetics studies have been conducted for Nuvaxovid. This is because pharmacokinetics studies are generally not needed for vaccines, consistently with current Guidelines on clinical evaluation of vaccines.
Q3: No biodistribution studies in animals were done for this vaccine: this is in line with guidelines from the World Health Organisation on non-clinical evaluation of vaccines (WHO 2005) and vaccine adjuvants and adjuvanted vaccines (WHO 2013).

Please note the European Medicines Agency have published a public assessment report for this product, which may provide further useful information. Please find a link to this below:
https://www.ema.europa.eu/en/medicines/h...

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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