Pre-licensing consideration of antigenic imprinting following vaccination with Pfizer-BioNTech COVID-19 vaccine (Comirnaty/tozinameran)

Medicines and Healthcare Products Regulatory Agency did not have the information requested.

Dear Medicines and Healthcare products Regulatory Agency (MHRA),

I am writing to make a request for information under section 1 of the Freedom of Information Act 2000.

Further to your response to my FOI request 'Antigenic imprinting following vaccination with Pfizer-BioNTech COVID-19 vaccine (Comirnaty/tozinameran)' (https://www.whatdotheyknow.com/request/a...), please can you confirm in particular whether the MHRA considered, as part of the process of licensing the Pfizer-BioNTech COVID-19 vaccine (Comirnaty/tozinameran) - ie, irrespective of any subsequently reported suspected side effects - the matter of the immune system's response to infection with SARS-CoV-2 variants as a result of the phenomenon of antigenic imprinting (AIM; also known as original antigenic sin/antigenic sin/the Hoskins effect) following vaccination with the above-mentioned vaccine.

Further, if the MHRA did consider the aforementioned matter, please can you provide any information which the MHRA holds on this matter.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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________________________________________ From: Kenneth MacArthur
<[FOI #812349 email]> Sent: Monday, November 29,
2021 7:18:58 PM To: MHRA Customer Services Subject: Freedom of Information
request - Pre-licensing consideration of antigenic imprinting following
vaccination with Pfizer-BioNTech COVID-19 vaccine (Comirnaty/tozinameran)
Dear Medicines and Healthcare products Regulatory Agency (MHRA), I am
writing to make a request for information under section 1 of the Freedom
of Information Act 2000. Further to your response to my FOI request
'Antigenic imprinting following vaccination with Pfizer-BioNTech COVID-19
vaccine (Comirnaty/tozinameran)'
(https://eur01.safelinks.protection.outlo...),
please can you confirm in particular whether the MHRA considered, as part
of the process of licensing the Pfizer-BioNTech COVID-19 vaccine
(Comirnaty/tozinameran) - ie, irrespective of any subsequently reported
suspected side effects - the matter of the immune system's response to
infection with SARS-CoV-2 variants as a result of the phenomenon of
antigenic imprinting (AIM; also known as original antigenic sin/antigenic
sin/the Hoskins effect) following vaccination with the above-mentioned
vaccine. Further, if the MHRA did consider the aforementioned matter,
please can you provide any information which the MHRA holds on this
matter. Yours faithfully, Kenneth MacArthur
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/1275

Dear Kenneth MacArthur,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 30th November 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

 

Dear Mr MacArthur,

 

MHRA received no data from the clinical trials to show that the phenomenon
of antigenic imprinting (also know as antigenic sin/Hoskin’s effect)
exists following administration of the Pfizer/BioNTech vaccine. As there
is no evidence of antigenic imprinting 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.

 

Best regards,

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 020 3080 6000

 

 

 

 

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Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency (MHRA),

Thank you for your response.

You have now clarified that there is no evidence of the occurrence of the phenomenon of antigenic imprinting (AIM; also known as original antigenic sin/antigenic sin/the Hoskins effect) following vaccination with the Pfizer-BioNTech COVID-19 vaccine (Comirnaty/tozinameran) - either in the clinical trials for this vaccine, or in the adverse event reports made following the vaccine's subsequent population-wide roll-out. However, the Omicron variant notwithstanding, we have observed only limited antigenic drift in SARS-CoV-2 up until the present moment, so this is perhaps unsurprising.

Your responses focus on the lack of empirical evidence for antigenic imprinting thus far - but I am asking if you considered the possibility of antigenic imprinting with this vaccine from a theoretical standpoint, irrespective of the empirical data observed up until this point in the pandemic. Can you confirm whether you did? The public assessment report does not mention this matter. If you did, please can you provide any information which you hold on this matter. If you did not, I would invite you to comment on why you did not.

Yours faithfully,

Kenneth MacArthur

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: Kenneth MacArthur
<[FOI #812349 email]> Sent: Tuesday, December 7,
2021 10:24:17 PM To: MHRA Customer Services Subject: Re: FOI 21/1275 CSC
78385 Freedom of Information request - Pre-licensing consideration of
antigenic imprinting following vaccination with Pfizer-BioNTech COVID-19
vaccine (Comirnaty/tozinameran) Dear Medicines and Healthcare products
Regulatory Agency (MHRA), Thank you for your response. You have now
clarified that there is no evidence of the occurrence of the phenomenon of
antigenic imprinting (AIM; also known as original antigenic sin/antigenic
sin/the Hoskins effect) following vaccination with the Pfizer-BioNTech
COVID-19 vaccine (Comirnaty/tozinameran) - either in the clinical trials
for this vaccine, or in the adverse event reports made following the
vaccine's subsequent population-wide roll-out. However, the Omicron
variant notwithstanding, we have observed only limited antigenic drift in
SARS-CoV-2 up until the present moment, so this is perhaps unsurprising.
Your responses focus on the lack of empirical evidence for antigenic
imprinting thus far - but I am asking if you considered the possibility of
antigenic imprinting with this vaccine from a theoretical standpoint,
irrespective of the empirical data observed up until this point in the
pandemic. Can you confirm whether you did? The public assessment report
does not mention this matter. If you did, please can you provide any
information which you hold on this matter. If you did not, I would invite
you to comment on why you did not. Yours faithfully, Kenneth MacArthur
-----Original Message----- Dear Mr MacArthur, MHRA received no data from
the clinical trials to show that the phenomenon of antigenic imprinting
(also know as antigenic sin/Hoskin’s effect) exists following
administration of the Pfizer/BioNTech vaccine. As there is no evidence of
antigenic imprinting 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. Best regards, MHRA
Customer Service Centre 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 #812349 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

Dear Kenneth MacArthur,

 

Thank you for your email.

 

We have nothing further to add to our previous response.

 

Kind regards,

 

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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