Covid-19

Mrs L Clay made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

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

Dear Medicines and Healthcare products Regulatory Agency,

In a previous FOI the MHRA Customer Service Centre stated, "The definition of a vaccine is “a substance used to stimulate the production of antibodies and provide immunity against one or several diseases prepared from the causative agent of a disease, its products, or a synthetic substitute, treated to act as an antigen without inducing the disease.” According to this definition, a vaccine does not have to be a live, active virus, and it can be an inactivated version of the virus or a synthetic substitute. The key factor is that it stimulates the production of antibodies and provides immunity, without causing the disease itself.

Please disclose all documentary evidence you hold which proves that the 'Covid-19' injections (repeatedly described as vaccines/vaccinations) being given to the population provide immunity to Covid-19 and do not cause the disease.

Yours faithfully,

Mrs L Clay

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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Medicines and Healthcare products Regulatory Agency
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/237

Dear Mrs L Clay,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 9 March 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.

Kind Regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/237
 
Dear Mrs Clay,
 
Thank you for your email.
 
The authorisation of the Pfizer/BioNTech and the Oxford/AstraZeneca
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.
 
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. This includes demographic data on the recipients
included in the study, including any concomitant illnesses. A link to this
is provided below:
[1]https://www.nejm.org/doi/full/10.1056/NE...
 
The approval for use of the Pfizer/BioNTech and Oxford/AstraZeneca
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...
 
Further to the above, the Moderna vaccine has also recently been
authorised for use. Further information on this is provided below:
[4]https://www.gov.uk/government/publicatio...
 
MHRA is collecting data concerning any adverse reactions observed to
vaccine treatment through our Yellow Card Scheme. The MHRA is publishing
Yellow Card data associated with COVID-19 vaccinations. Yellow Card data
for drugs is routinely published on the Yellow Card website, with vaccine
data available on request. However, for COVID-19 vaccinations are
proactively publishing details of adverse drug reactions received,
including MHRA assessment of the data to provide context.
[5]https://www.gov.uk/government/publicatio...
  
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: [6][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
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Please remember to quote the reference number above in any future
communications.
 
If you were to remain dissatisfied with the outcome of the internal
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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
 

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Dear whoever receives this at MHRA Customer Services,

You have not provided documentary evidence that these injections are vaccinations, nor that they are safe or effective. Indeed, your having to spend over £1million on AI technology to capture the adverse side effects, due to your systems not being able to cope with the amount of them speaks volumes.

A vaccine needs to stimulate an immunity and disrupt transmission. These experimental injections do neither. They are NOT vaccines. You know it, I (and many others) know it, and many credible scientists in the field know it too.

As you have seen, I gave you my name when I put my FOI request to you, and it is again below. Please do me the courtesy of including the name of the man or woman within the MHRA Customer Services who is replying.

Yours sincerely,

Mrs L Clay

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...