Emergency Authorisation of Covid Vaccines: Criteria for End of Emergency

Branwen Sloper 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,

Since authorisation for unapproved covid vaccines was granted based on a state of emergency, please explain
(i) What criteria must be met to declare the emergency is over?
(ii) Which authority is responsible for determining the emergency status - and the end of the emergency?
(iii) What is the procedure for declaring the end of the emergency?
(iv) What is the process for withdrawal of the emergency authorisation for covid vaccines?

Yours faithfully,

B Sloper

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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London 
E14 4PU
gov.uk/mhra
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The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: Branwen Sloper
<[FOI #825150 email]> Sent: Saturday, January 22,
2022 6:09:23 PM To: MHRA Customer Services Subject: Freedom of Information
request - Emergency Authorisation of Covid Vaccines: Criteria for End of
Emergency Dear Medicines and Healthcare Products Regulatory Agency, Since
authorisation for unapproved covid vaccines was granted based on a state
of emergency, please explain (i) What criteria must be met to declare the
emergency is over? (ii) Which authority is responsible for determining the
emergency status - and the end of the emergency? (iii) What is the
procedure for declaring the end of the emergency? (iv) What is the process
for withdrawal of the emergency authorisation for covid vaccines? Yours
faithfully, B Sloper
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/412

Dear B Sloper,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 24 January 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 22/412
 
Dear B Sloper,
 
Thank you for your email.
 
The Medicines & Healthcare products Regulatory Agency (MHRA) in the United
Kingdom (UK) granted emergency use authorisation (EUA) to the Covid-19
vaccine BNT162b2 supplied by Pfizer and BioNTech under Regulation 174 of
the Human Medicine Regulations 2012 on 2 December 2020. This followed the
previous authorisations for Covid-19 vaccines by China and Russia for
their own vaccines. The recent announcements have created great hope for a
path out of this global pandemic. This brief article seeks to demystify
the concept of EUAs and highlight some important considerations as we can
expect more submissions for Covid-19 vaccine authorisations in the near
future. Our key take-away is that although emergency use authorisations
are temporary and subject to ongoing data reviews, regulatory agencies
follow rigorous evidence-based approaches to ensure the safety of vaccines
authorised using this pathway.
 
An Emergency Use Authorisation (EUA) is a regulatory mechanism to
facilitate the availability and use of medical countermeasures, including
unapproved or investigational health products, during public health
emergencies, such as the current Covid-19 pandemic. National Regulatory
Authorities (NRAs) can issue an EUA when certain legal criteria have been
met such as a national health emergency and/or no adequate, approved, and
available alternatives. It is not just NRAs that can use emergency use
mechanisms.  After the experience during the West African Ebola outbreak
from 2013-2016, the World Health Organisation (WHO) developed the
Emergency Use Assessment and Listing (EUAL) procedure for health products
which was updated in January 2020 with the Emergency Use Listing (EUL)
procedure3.
 
The specific conditions of emergency use mechanisms may differ among
jurisdictions and in some jurisdictions similar regulatory mechanisms may
have different names. A common element of most emergency use procedures is
an assessment of whether submitted (and frequently limited) data
demonstrate a reasonable likelihood that a product’s quality, safety, and
efficacy are acceptable, and that the benefits outweigh potential risks
and uncertainties in the context of a public health emergency of national
or international concerns.
 
The authorisation announced in the United Kingdom under Regulation 174 is
temporary and only relates to a limited number of specific batches of the
Covid-19 vaccine BNT162b2 supplied by Pfizer and BioNTech, in response to
the increased spread of Covid-19 and deaths in the UK. The conditions of
the EUA stipulate that the sponsor “must operate a comprehensive
pharmacovigilance (safety monitoring) system for this product in
accordance with UK legislation for licensed products, as if they were
market authorisation holders.4” This clause ensures that processes are in
place to monitor changes in the benefit-risk profile of the vaccine, and
facilitate timely revisions to its use, if required.
 
EUAs are a powerful tool in the public health response arsenal for
countries during this pandemic. However, it is important to understand
that unlike full market authorisation, they do not make Covid-19 vaccines
generally available to the whole population in the same way as influenza
vaccines. Rather, they allow governments to deploy available new vaccines
as quickly as possible to specific groups of the most vulnerable people
such as frontline healthcare workers, older people and other high-risk
groups while collecting important data on the novel vaccines to make
decisions about broader immunisation programmes.
 
Please note that a marketing authorisation was granted for the
Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC)
decision on 21 December 2020 (PLGB 53632/0002).
 
Please also note that a marketing authorisation was granted for the
Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB
53720/0002).
 
A marketing authorisation has been granted for the Janssen Covid-19
vaccine on 28 May 2021 (PLGB 00242/0742).
 
A marketing authorisation was granted for the Oxford/AstraZeneca vaccine
on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355)
 
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
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If you were to remain dissatisfied with the outcome of the internal
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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 'Emergency Authorisation of Covid Vaccines: Criteria for End of Emergency'.

I asked for three specific items of information relating the the "Emergency".
None has been supplied.
Nor any direction to a source of information.

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

Yours faithfully,

Branwen Sloper

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: Branwen Sloper
<[FOI #825150 email]> Sent: Tuesday, February 15,
2022 9:19:40 AM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Emergency Authorisation of Covid
Vaccines: Criteria for End of Emergency 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 'Emergency Authorisation of Covid Vaccines: Criteria for End
of Emergency'. I asked for three specific items of information relating
the the "Emergency". None has been supplied. Nor any direction to a source
of information. 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, Branwen Sloper
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #825150 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 22/412

Dear Branwen Sloper,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/412. 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

Dear Branwen Sloper

Thank you for your correspondence.

Regarding your request for an internal review of 22/412. We would like to handle this request in two phases.

Firstly, in relation to questions i), ii), iii) listed below for reference - we confirm that we do not hold this information and suggest that the appropriate organisations to contact are DHSC (please see make an FOI request section, near the bottom of the webpage, and the HSA (UK Health Security Agency), please refer to the similar section of their webpage for contact details. Please let us know if you would like us to contact these organisations directly on your behalf.

(i) What criteria must be met to declare the emergency is over?
(ii) Which authority is responsible for determining the emergency status - and the end of the emergency?
(iii) What is the procedure for declaring the end of the emergency?

In relation to part (iv) of the original FOI request:

"(iv) What is the process for withdrawal of the emergency authorisation for covid vaccines?"

We consider that the original response should have engaged Section 35 (formulation of government policy). Section 35 is a qualified exemption that is subject to a test of the public interest. In accordance with the FOI Act, MHRA will now perform a test of public interest on the requested information to ascertain whether withholding some or all of this information is justified. Therefore, we will unfortunately, not be able to answer within usual 20 working days to process an internal review.

In relation to the topic of internal reviews, the ICO guidance states "there may be circumstances where you require more time to complete an internal review, for example if you need to address complex issues, consult with third parties or consider substantial amounts of information". In a related passage the ICO guidance suggests that an extension should be no more than an additional 20 working days, unless there are legitimate reasons why a longer extension is necessary. We intend to comply with this recommendation and as such, the deadline for providing our internal review will now be 31st March. However, please note that where possible we will aim to conclude the review prior to the adjusted deadline.

Please quote the above reference number on any future communications.

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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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 22/412

 

Dear Branwen Sloper,

 

Thank you for your email.

 

As mentioned in our previous email, the information that is subject this
aspect of your FOI request relates to the formulation or development of
government policy and therefore, section 35 (1) (a) of the Freedom of
Information Act 2000 has been considered within the scope of this internal
review. In line with the terms of this exemption, we have deliberated
whether it would be in the public interest for us to provide you with the
information. In this case, we have concluded that the public interest does
not outweigh the foreseeable negative consequences on the development of
future policy, or on any further development of the policy concerned.

 

We have considered that FOIA in its default interpretation favours release
of information, and we also considered that releasing the ‘early / draft’
withdrawal policy would appear to improve openness and transparency.
However, these points were counterbalanced by an understanding of the
risks associated with releasing details of an evolving policy area, and a
perspective that the direct benefits of providing this information to the
public domain would be considered limited, even if the policy was in a
final form and therefore, the value of releasing a draft version would be
further diminished.

 

Therefore, the conclusion of our internal review is to exempt the
information under Section 35 (formulation or development of government
policy).

 

We appreciate that this internal review has reached a different conclusion
from the original response, which, instead discussed the basis for
temporary authorisation under Regulation 174 and provided additional
details that were not directly related to the questions asked. We
apologise for this oversight and expect improved clarity from this point
forward when / if any similar requests are addressed in future.  

 

If you remain dissatisfied, you may ask the Information Commissioner (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

 

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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