Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19

Mae'r ymateb i'r cais hwn wedi cael ei oedi. Yn ôl y gyfraith, dylai Medicines and Healthcare Products Regulatory Agency fel arfer wedi ymateb yn brydlon a erbyn (manylion)

Dear Medicines and Healthcare products Regulatory Agency,

Please supply the data to back up your statement that "Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19."

In particular I would like to see evidence comparing the experimental vaccines v Ivermectin and Hydroxychloroquine.

Yours faithfully,

Paul Lewis

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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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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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

 

Our Ref: FOI 21/493

       

Dear Paul Lewis

       

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

Thank you for your enquiry which we received on 7^th 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

Dear MHRA Customer Services,

any chance of a reply

thanks

Paul Lewis

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

FOI 21/493

 

Dear Mr Lewis,

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...

 

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:

[8]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: 

[9]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:

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

 

Regarding your question concerning the MHRA statement “Vaccination is the
single most effective way to reduce deaths and severe illness from
COVID-19", we have provided links to the MHRA’s PARs for each of the
vaccines, which show the effective reduction in deaths and severe illness
in recipients of the authorised vaccines. Further to this, sufficient
evidence has not been provided to MHRA to show that either ivermectin or
hydroxychloroquine are effective in the prevention of deaths and severe
illness from Covid-19 infection.

With regards to your comment that these are experimental vaccines, MHRA
does not consider these vaccines to be experimental. The main efficacy and
safety results for the Phase I, II and III trials have been submitted to
MHRA, sufficient that these vaccines can be authorised for use in the
patient populations stated in the Information for Healthcare
Professionals/Summary of Product Characteristics for each vaccine. These
studies are currently ongoing to follow-up vaccine recipients to collect
additional safety data, in the same way that all clinical trials for new
medicines follow up their study subjects after the main results of the
study have been reported. Other studies that are currently in progress are
either for cohorts/subpopulations of recipients (such as pregnant women or
children/adolescents) or to investigate different regimens (such as giving
different brands of vaccine for the first and second doses).

 

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: [11][MHRA request email] .

 

Please remember to quote the reference number above in any future
communications. Please note, 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.

 

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

 

dangos adrannau a ddyfynnir

Dear MHRA Customer Services,

Are people being made aware, before these drugs are injected, that they are taking part in a trial

Provide the data to back up your statement "This is because the evidence shows that one dose of either vaccine provides a high level of protection from Covid-19. "

And who are the people that have made these decisions, as they need to be tried for crimes against humanity.

thanks

Paul Lewis

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...