US DoD Medical Countermeasures

Our Ref: FOI 22/047

Dear Dan Couzens,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 17 January 2023.

We 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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Our Ref: FOI 23/047

Dear Mr Couzens,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 24 January 2023.

Apologies for the error we confirm that your reference number is FOI 23/047 not FOI 22/047.

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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FOI 23/047
 
Dear Mr Couzens,
 
Thank you for your request under the Freedom of Information Act (FOIA).
 
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 required 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.
 
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.
 
There is no reluctance by MHRA to withdraw marketing authorisations for
products where there is no positive benefit/risk. The vaccines are safe
for use and have been shown to be efficacious for the proposed
indications.
 
The MHRA has in place a comprehensive strategy to monitor the safety of
the COVID-19 vaccines authorised in the UK. This monitoring strategy is
continuous, proactive and based on a wide range of information sources.
The Yellow Card scheme is one of the sources of information used in the
monitoring strategy and is the UK system for healthcare professionals and
patients to report suspected side effects or adverse reactions to
medicines and vaccines. Further details on the monitoring strategy
including the Yellow Card Scheme can be found here:
[1]https://www.gov.uk/government/publicatio...
 
The MHRA’s view is that the benefits of the vaccines in preventing serious
complications associated with COVID-19 far outweigh any currently known
side effects in the majority of patients. The MHRA will continue to
carefully review and monitor all reports of suspected side effects
submitted to us following COVID-19 vaccination. When a safety issue is
confirmed the MHRA will act promptly to inform patients and healthcare
professionals and take appropriate steps to mitigate any identified risk.
 
As the licensing authority, our authorisation of each of the vaccines has
been published on our websites, along with the Public Assessment Reports,
Summaries of Product Characteristics and Patient Information Leaflets.
These also clearly indicate the dates of authorisation for each of the
vaccines. All sites involved in the manufacture of the vaccine have been
inspected to show that they comply with current Good Manufacturing
Practice, as we do  for all authorised medicinal products.
 
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.
 
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 Mr Couzens,

We acknowledge that the enquiry is outstanding and we apologise for the delay.

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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CEC 138383
 
Dear Mr Couzens,
 
Thank you for your email.
 
Please find below the answers to the questions you have raised below.
 
What level of interaction did MHRA have with the US DoD reference their
medical countermeasures programme in the manufacturing, supply and
delivery of the mRNA biologics? Why have you skirted the question
regarding the CCP owned company Fosun being involved in the mRNA supply
chain?
MHRA corresponds with marketing authorisation holders concerning the data
that they have submitted to obtain a marketing authorisation for their
product. We do not correspond or interact with the US Dept of Defence.
Regarding the manufacturers that are used for any medicinal products that
are granted marketing authorisations, we do not divulge that information,
it is exempt under S41/S43 of the FOIA.
 
Since the Omicron variant of COVID-19 the so called benefits outweighing
the risks (of COVID19 death/injury) have been shown to be completely
opposite.  What work has MHRA done around the igG4 immune response the
boosted population now mount toward reinfection with coronaviruses? This
allergy-like response where victims show no outward signs of
cold/infection, primes their immune systems to ignore the virus, leaving
it to do untold damage to organs.
MHRA’s clinical assessment, the EMA’s clinical assessment and the clinical
data from the trials have been published. None of these show any adverse
events that would match the effects referred to above. The MHRA has
closely monitored the safety of all COVID-19 vaccines used in the UK
immunisation programme, and published summaries of its safety assessments
here [1]Coronavirus (COVID-19) vaccines adverse reactions - GOV.UK
(www.gov.uk) The UK Health Security Agency publishes information on the
impact of the vaccination programme here [2]COVID-19 vaccine monthly
surveillance reports (week 39 2021 to week 14 2023) - GOV.UK (www.gov.uk) 
MHRA’s position remains that the benefits of the vaccines in preventing
COVID-19 and serious complications associated with COVID-19 far outweigh
any currently known side effects.
 
Why does MHRA continue to push this failed product onto the UK population
for a health emergency that no longer exists?
We advise that you can review the MHRA Public Assessment Reports and the
EMA Public Assessment Reports that are published to understand why these
products are authorised for use. While the MHRA authorises and regulates
medicinal products including COVID-19 vaccines, we do not advise on
vaccination policy, this is the remit of the Joint Committee on
Vaccination and Immunisation. 
 
When is the EUA review, since their is no longer a Pandemic/Health
Emergency, then when will MHRA nullify the emergency use of this
thoroughly untested therapeutic?
There is no such thing as Emergency Use. We authorised some batches of
COVID-19 vaccines under Regulation 174 at the start of the vaccine
rollout. However, all vaccines that were authorised under Regulation 174
now have marketing authorisations granted.
 
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 Experience Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

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Dear Dan Couzens,

Thank you for your email. We have now looked at the full history of your FOI request 23/047. We see that your first request for an Internal Review was mistaken for a further request for more information, as more questions were asked. This was then handled as a customer services enquiry (CEC 138383) rather than a new FOI.

Following our response to CEC 138383 you requested an Internal review of FOI 23/047 on 29 August 2023, but no response was provided. You have again asked for an Internal review of FOI 23/047 on 15 July 2024.

We accept that your request for an Internal review for FOI 23/047 was overlooked and we'd like to apologies for this. We will now be conducting an Internal Review of your original request FOI 23/047. We aim to provide you with a response by 13 August 2024.

Kind regards,

Freedom of Information Manager
MHRA Customer Experience Centre
Communications and Engagement Team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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Dear Mr Couzens

Apologies for the delay in sending this to you. However, please see
attached our internal review for FOI 23/047.

Best regards

MHRA Central Freedom of Information Team

Medicines & Healthcare products Regulatory Agency

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Dear Mr Couzens,

Off the back your complaint to the ICO regarding FOI23/047 we have
reviewed our position and are issuing a revised response. We have advised
the ICO we are doing such and they may be in touch to confirm.

We believe this revised response should satisfy what you are looking for
in question 3 of your original request.

Thanks

Conor Lyons

Freedom of Information Manager

MHRA Customer Experience Centre

Communications and Engagement Team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

DISCLAIMER This email and any files transmitted with it are confidential.
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please notify the sender immediately by using the reply function and then
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