Immune system's response to pathogens following COVID-19 vaccination

Yn disgwyl am adolygiad mewnol gan Medicines and Healthcare Products Regulatory Agency o'u triniaeth o'r cais hwn.

Kenneth MacArthur

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.

Please can you confirm whether the MHRA holds any information which relates to the immune system's response to (i) previously and currently circulating variants of SARS-CoV-2 (ii) variants of SARS-CoV-2 which may circulate in the future, and (iii) other pathogens, following vaccination with any COVID-19 vaccine, as a result of any of the following phenomena:
a) Original antigenic sin (also referred to as antigenic sin/antigenic imprinting/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)

If any such information exists, please can you provide it to me.

For clarity, "information" refers to all recorded information held by the MHRA - including, but not limited to, e-mails and other correspondence, text messages (including SMS, iMessage, WhatsApp and Telegram messages), messages on internal chat systems (such as Slack, Hangouts and Microsoft Teams), reports and other documents (including unfinished/unpublished versions of such), notes (including meeting notes), and transcripts.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
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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. 

References

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1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

 

Our Ref: FOI 21/550

       

Dear Kenneth MacArthur,

       

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

Thank you for your enquiry which we received on 23 May 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.

[1]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

 

 

 

dangos adrannau a ddyfynnir

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/550

 

Dear Mr MacArthur

 

Thank you for your email.

 

The temporary authorisations of the Pfizer/BioNTech, Oxford/AstraZeneca
and Moderna vaccines was done through an expedited rolling review. A
‘rolling review’ can be used to complete the assessment of a promising
medicine or vaccine during a public health emergency in the shortest time
possible. This is done as the packages of data become available from
ongoing studies on a staggered basis. The temporary authorisation under
Regulation 174 permits the supply of identified vaccine batches, based on
the safety, quality and efficacy data submitted to MHRA. These
authorisations do not constitute a marketing authorisation.

 

All vaccines are tested through three phases of clinical trials to ensure
they meet the gold standard. Phase 1 trials are with a small group of
people to make sure there are no safety concerns and determines the
appropriate dosage for the best immune response. Phase 2 trials are
conducted on a larger group of people to check the vaccine works
consistently and that the immune response is sufficient. Phase 3 trials
test the vaccines on thousands of people for scientists to assess if the
vaccine is producing immunity that will prevent disease. Usually, these
phases are run in sequence, but in an effort to find a safe and effective
Covid-19 vaccine as quickly as possible, once safety has been ascertained
through Phase 1, Phases 2 and 3 are being run in parallel. Extensive
checks and balances are required at every stage of the development of a
vaccine, and this is no different for a Covid-19 vaccine. No stages in the
vaccine development processes were bypassed.

 

Information on the study conducted using the Pfizer/BioNTech vaccine and
its results are available in a peer-reviewed journal, the New England
Journal of Medicine (NEJM). A link to this is provided below:

[1]https://www.nejm.org/doi/full/10.1056/NE...

 

The temporary authorisations for use of the COVID-19 vaccines in the UK
followed a rigorous scientific assessment of all the available evidence of
quality, safety and effectiveness by the UK regulator, the Medicines and
Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists
and clinicians reviewed data from the laboratory pre-clinical studies,
clinical trials, manufacturing and quality controls, product sampling and
testing of the final vaccine, and also considered the conditions for its
safe supply and distribution. The decision was made with advice from the
Commission on Human Medicines (CHM), the government’s independent expert
scientific advisory body. Regarding the MHRA approval of the
Pfizer/BioNTech and the Oxford/AstraZeneca COVID-19 vaccines, further
information (including information for physicians and recipients of the
vaccine, and Public Assessment Reports [PARs] for each vaccine) are
available on the MHRA website. Links to these are provided below:

[2]https://www.gov.uk/government/publicatio...

[3]https://www.gov.uk/government/publicatio...

[4]https://www.gov.uk/government/publicatio...

 

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). Further information is
available on the European Medicines Agency (EMA) website, a link to this
is provided below:

[5]https://www.ema.europa.eu/en/medicines/h...

 

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). Further information is available on the MHRA website and the
EMA website, links to these are provided below:

[6]https://www.gov.uk/government/publicatio...

[7]https://www.ema.europa.eu/en/medicines/h...

 

A marketing authorisation has been granted for the Janssen Covid-19
vaccine on 28 May 2021. Further information is available via the below
link:

[8]https://www.gov.uk/government/publicatio...

 

In addition, the European Commission, following recommendations from the
European Medicines Agency (EMA), have granted a marketing authorisation
for the Oxford/AstraZeneca vaccine. Further information is provided below:

[9]https://www.ema.europa.eu/en/medicines/h...

 

As with any vaccine or medicine, COVID-19 vaccines require continuous
safety monitoring and that the benefits in protecting people against
COVID-19 outweigh any side effects or potential risks. This is a process
known as safety monitoring (pharmacovigilance). This ensures that any
potential medium and long term safety issues are promptly and adequately
evaluated. As part of our signal detection processes, all adverse reaction
reports received are individually assessed and cumulative information
reviewed at regular intervals. Be reassured that the MHRA is working in
collaboration with partners in the health system to rapidly assess all
available safety data in real time and communicate any emerging issues, as
necessary.

 

Throughout this global pandemic, we have always been guided by the latest
scientific advice. Having studied evidence on both the Pfizer/BioNTech and
Oxford/AstraZeneca vaccines, the Joint Committee on Vaccination and
Immunisation (JCVI) has advised that we should prioritise giving as many
people in at-risk groups their first dose, rather than providing two doses
in as short a time as possible.

 

The four UK Chief Medical Officers agree with JCVI that at this stage of
the pandemic prioritising the first doses of vaccine for as many people as
possible on the priority list will protect the greatest number of at risk
people overall in the shortest possible time and will have the greatest
impact on reducing mortality, severe disease and hospitalisations and in
protecting the NHS and equivalent health services.

 

This is because the evidence shows that one dose of either vaccine
provides a high level of protection from Covid-19. 

 

For both vaccines, data provided to MHRA demonstrate that whilst efficacy
is optimised when a second dose is administered both offer considerable
protection after a single dose, at least in the short term. For both
vaccines the second dose completes the course and is likely to be
important for longer term protection.

 

The NHS across the UK will prioritise giving the first dose of the vaccine
to those in the most high-risk groups. Everyone will still receive their
second dose and this will be within 12 weeks of their first. The second
dose completes the course and is important for longer-term protection.

 

The JCVI’s independent advice is that this approach will maximise the
benefits of both vaccines allowing the NHS to help the greatest number of
people in the shortest possible time.  It will ensure that more at-risk
people are able to get meaningful protection from a vaccine in the coming
weeks and months, reducing deaths and starting to ease pressure on our
NHS.

 

The following Department of Health and Social Care (DHSC) webpage for the
independent report ‘Optimising the COVID-19 vaccination programme for
maximum short-term impact’ from the Joint Committee on Vaccination and
Immunisation (JCVI) provides the rationale for the government’s
implemented dosing strategy: 

[10]https://www.gov.uk/government/publicatio...

 

Further, the scientific basis from the JCVI concerning the current
evidence on efficacy after single doses of the Pfizer/BioNTech,
Oxford/AstraZeneca and Moderna vaccines is available in the public domain
and is provided below:

[11]https://www.gov.uk/government/publicatio...

 

Regarding your specific question, MHRA holds no data on (i) previously and
currently circulating variants of SARS-CoV-2 (ii) variants of SARS-CoV-2
which may circulate in the future, and (iii) other pathogens, following
vaccination with any COVID-19 vaccine, as a result of any of the phenomena
you have listed.

 

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: [12][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

Cheshire

SK9 5AF

 

Yours sincerely

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

 

 

dangos adrannau a ddyfynnir

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 'Immune system's response to pathogens following COVID-19 vaccination'.

Thank you for your response, which helpfully collected together a large amount of information already in the public domain. However, it did not substantively address my request.

With regards my request itself, you say that "MHRA holds no data". I find this hard to believe, and wonder if it is due to an overly literal interpretation of my request, whereby for some reason the precise wording of scenarios (i), (ii) and (iii) does not exactly match the information which you hold. Specifically, I find it hard to believe that you have not considered at all the issues of (a) original antigenic sin, (b) antibody-dependent enhancement, or (c) reprogramming of the innate immune system (or the alternative/additional names for these phenomena which I have listed) in the context of COVID-19 vaccines, and therefore that you hold no information on the matter.

Can you confirm if it is really the case that you have not considered at all the issues of (a) original antigenic sin, (b) antibody-dependent enhancement, or (c) reprogramming of the innate immune system (by these or the other listed names) in the context of COVID-19 vaccines, and therefore that you hold no information on the matter? If that is not the case, please can you now provide the information to me.

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

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. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 21/550

Dear Kenneth MacArthur,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/550. 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

dangos adrannau a ddyfynnir