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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: Kenneth MacArthur
<[FOI #817787 email]> Sent: Tuesday, December 21,
2021 10:51:22 AM To: MHRA Customer Services Subject: Freedom of
Information request - Immunological phenomena in connection with
vaccination with Pfizer-BioNTech COVID-19 vaccine (Comirnaty/tozinameran)
Dear Medicines and Healthcare products Regulatory Agency (MHRA), Please
can you confirm whether the MHRA has considered, from a theoretical,
first-principles standpoint, irrespective of the empirical data observed
in clinical trials and more broadly up until the current point in the
pandemic, any or all of the following immunological phenomena in
connection with vaccination with the Pfizer-BioNTech COVID-19 vaccine
(Comirnaty/tozinameran): a) Antigenic imprinting (AIM; also known as
original antigenic sin/antigenic sin/the Hoskins effect) b)
Antibody-dependent enhancement (also referred to as immune
enhancement/disease enhancement) c) Reprogramming of the innate immune
system induced by said vaccination (including the phenomena of trained
immunity and innate immune tolerance) Further, if the MHRA has considered
the aforementioned, please can you provide any information which the MHRA
holds on this. For emphasis and for the avoidance of doubt, please note
that this request for information relates to consideration you have made
from a theoretical, first-principles standpoint, rather than based on
empirical data arising from administration of the vaccine. Yours
faithfully, Kenneth MacArthur
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #817787 email] Is [MHRA request email] the wrong
address for Freedom of Information requests to Medicines and Healthcare
Products Regulatory Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
Disclaimer: This message and any reply that you make will be published on
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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

Our Ref: FOI 21/1343

Dear Kenneth MacArthur,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 21st December 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

show quoted sections

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: Kenneth MacArthur
<[FOI #817787 email]> Sent: Saturday, January 22,
2022 10:22:48 AM To: MHRA Customer Services Subject: Re: FOI 21/1343 CSC
81314 Freedom of Information request - Immunological phenomena in
connection with vaccination with Pfizer-BioNTech COVID-19 vaccine
(Comirnaty/tozinameran) Dear Medicines and Healthcare products Regulatory
Agency, It is now over 20 working days since I submitted this request.
This means that the time limit specified in section 10(1) of the Freedom
of Information Act 2000 has been exceeded. Please can you now respond to
my request forthwith. Yours faithfully, Kenneth MacArthur -----Original
Message----- Our Ref: FOI 21/1343 Dear Kenneth MacArthur, RE: REQUEST
UNDER THE FREEDOM OF INFORMATION ACT 2000 Thank you for your enquiry which
we received on 21st December 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://eur01.safelinks.protection.outlo...
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:
[FOI #817787 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

FOI 21/1343

Dear Kenneth MacArthur,

Thank you for your email of 21 December where you have asked “Please can
you confirm whether the MHRA has considered, from a theoretical,
first-principles standpoint, irrespective of the empirical data observed
in clinical trials and more broadly up until the current point in the
pandemic, any or all of the following immunological phenomena in
connection with vaccination with the Pfizer-BioNTech COVID-19 vaccine
(Comirnaty/tozinameran):

a) Antigenic imprinting (AIM; also known as original antigenic
sin/antigenic sin/the Hoskins effect)

b) Antibody-dependent enhancement (also referred to as immune
enhancement/disease enhancement)

c) Reprogramming of the innate immune system induced by said vaccination
(including the phenomena of trained immunity and innate immune tolerance)”

In regards to your question a) Antigenic imprinting (AIM; also known as
original antigenic sin/antigenic sin/the Hoskins effect) you have been
provided information previously and our position remains the same.

The Freedom of Information Act places a general duty on public authorities
to provide access to official information.  However, the Act also provides
an exemption to that duty for requests that are determined to be
vexatious. As such we are refusing your request under Section 14 (1) of
the Freedom of Information Act.

Regarding your questions (b) and (c):

MHRA received no data from the clinical trials to show that the phenomena
of antibody-dependent enhancement (also referred to as immune
enhancement/disease enhancement) or reprogramming of the innate immune
system induced by said vaccination (including the phenomena of trained
immunity and innate immune tolerance) exists following administration of
the Pfizer/BioNTech vaccine. As there is no evidence for either phenomena
in the clinical trials for MHRA to consider, we hold no further
information on this matter. The Public Assessment Reports (PARs) written
by MHRA and the European Medicines Agency (EMA) contain the assessment by
these bodies of the Pfizer/BioNTech vaccine. Links to these have been
provided to you in previous responses

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

show quoted sections

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: Kenneth MacArthur
<[FOI #817787 email]> Sent: Saturday, January 29,
2022 11:03:32 AM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Immunological phenomena in connection
with vaccination with Pfizer-BioNTech COVID-19 vaccine
(Comirnaty/tozinameran) Dear Medicines and Healthcare products Regulatory
Agency (MHRA), Please pass this on to the person who conducts Freedom of
Information reviews. I am writing to request an internal review of the
MHRA's handling of my FOI request 'Immunological phenomena in connection
with vaccination with Pfizer-BioNTech COVID-19 vaccine
(Comirnaty/tozinameran)'. Firstly, regarding question (a), I refute the
contention that my request may be considered vexatious under section 14(1)
of the Freedom of Information Act (FOIA) 2000, and I would invite you to
withdraw this contention. In so doing, I refer you to paragraph 28 of the
ICO's guidance document 'Dealing with vexatious requests (section 14)'
(https://eur01.safelinks.protection.outlo...
"... an individual who submits frequent requests may only be doing this in
order to obtain further clarification because the public authority’s
previous responses have been unclear or ambiguous." In previous responses
to my requests regarding consideration of the immunological phenomenon of
antigenic imprinting in connection with vaccination with the
Pfizer-BioNTech COVID-19 vaccine (Comirnaty/tozinameran), you have
referred to there being no evidence for this phenomenon either from
clinical trials or from post-authorization pharmacovigilance, and that as
a result of this lack of evidence you hold no information on the matter.
However, the lack of evidence from clinical trials or from
post-authorization pharmacovigilance is not relevant to this request,
which makes clear it relates to "a theoretical, first-principles
standpoint", irrespective of the empirical data. At best, it has been
unclear and/or ambiguous from your previous responses whether you have
considered the phenomenon from a theoretical, first-principles standpoint.
To be clear, it does not logically follow that a lack of empirical data
(from clinical trials or from post-authorization pharmacovigilance) means
that you hold no information on the matter of the above-mentioned
phenomenon, since you could still have considered the matter from a
theoretical, first-principles standpoint, and thus would hold information
arising from such consideration. The same argument can be applied to your
response to questions (b) and (c). If you have not considered any of the
immunological phenomena listed in (a), (b) or (c) from a theoretical,
first-principles standpoint, please simply say so. That would then explain
why you hold no information regarding such consideration. (In this case,
per section 16 FOIA 2000 on the duty to provide advice and assistance, you
would ideally provide some explanation of why you have not considered
these phenomena from a theoretical, first-principles standpoint, but this
is a separate matter from the question of whether you have done so, and
thus whether you hold information regarding such consideration.) However,
please do not continue to refer to evidence from clinical trials or
post-authorization pharmacovigilance, since this request does not relate
to them. 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, Kenneth MacArthur
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #817787 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

Internal Review of FOI 21/1343

Dear Kenneth MacArthur,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/1343. 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

show quoted sections

Internal Review of FOI 21/1343

Dear Kenneth Macarthur,

Thank you for your follow-up reply and a request for an internal review.
We note that this is the 9^th FOI request we have received from you on the
subject of COVID-19 vaccines and this is the 3^rd request for an internal
review.

We would like to re-affirm that that we do not hold the data requested,
and we also wish to highlight that MHRA carefully reviewed the clinical
trial data when the vaccine was first approved for use, since then ~10
billion Pfizer COVID-19 vaccine doses have been administered. Detailed
surveillance of the safety data on COVID-19 vaccines is undertaken and the
modes of surveillance are discussed on the below webpage.

[1]Report of the Commission on Human Medicines Expert Working Group on
COVID-19 vaccine safety surveillance - GOV.UK (www.gov.uk) 

The COVID-19 vaccine safety data is published weekly and contains detailed
information on all the adverse events, please see below.

[2]Coronavirus (COVID-19) vaccines adverse reactions - GOV.UK (www.gov.uk)

The MHRA, along with all the major international regulatory authorities,
believe that the benefit/risk profile of the Pfizer vaccine is positive. 
The safety data are reviewed by our expert advisory committees who include
vaccine experts knowledgeable about original antigenic sin and
antibody-dependent enhancement of disease.

Thank you for your enquiry under the FOI act, this concludes or internal
review. However, if you remain dissatisfied, 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

Yours sincerely

MHRA Customer Experience 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

show quoted sections