When are the ‘Covid-vaccine’ harms enough?

Bartholomeus Lakeman

Dear Medicines and Healthcare Products Regulatory Agency,

Please answer the 7 questions (below) related to the following facts:

[Extraneous material removed]

In consideration of abovementioned facts; it is in the public interest for you to provide with evidence the proof of that the Covid vaccines:
1) Do not cause prions. And if it does; will that affect its Emergency Use Authorization (EUA)?
2) Do not contain Graphene Oxide (GO) nanoparticles or similar scanning and toxic material. And if it contains GO (and yet not listed as its ingredients) will that affect its EUA status?
3) Its ADRs are not related for about 75% to Bleeding, Clotting and Ischaemic fatalities. And what is the evidence for to state that said reported vaccine’s ADRs are not related to its biodistribution?
4) Its Good Laboratory Practices (GLP) were diligently verified by MHRA. And if not; then why is there of said ‘vaccines’ no a risk-benefit analysis? And its genotoxicity data were fully provided to MHRA. And if not; will that affect its EUA?
5) Its NNTV to prevent one COVID-case is not between 200–700, and its NNTV to prevent one COVID-death is not 9000 or more doses. And for each death prevented by vaccination; how many deaths and terminal injuries inflicted by vaccination will cause its EUA to be withdrawn?
6) Its deaths are not certified as Covid-deaths, and its future number of deaths is not aimed to realise the zero carbon-dioxide (CO2) output in 2050 or the depopulation agenda of Bill Gates, the World Economic Forum, the WHO, and UN.
7) Its risk-benefit analysis has been published to fulfil MHRA duty to facilitate an informed consent.

Yours faithfully,
Bartholomeus Lakeman

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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E14 4PU
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References

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/785
       
Dear Bartholomeus Lakeman,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 7th July 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

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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/785

 

Dear Bartholomeus Lakeman

 

Thank you for your email.

 

Please see below our response to the seven points that you raise:

 

1)          Do not cause prions. And if it does; will that affect its
Emergency Use Authorization (EUA)?

None of the vaccines cause prions and there is no evidence that the
vaccine contains mRNA molecules might cause ribosomes to create aberrant
proteins, like prions. Please also note that the authorisation of the
vaccines under Regulation 174 has now been superseded by marketing
authorisations.

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:

[1]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:

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

[3]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:

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

 

In addition, a marketing authorisation was granted for the
Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance
Procedure (PLGB 17901/0355). Further information is available on the MHRA
website and the EMA website, links to these are provided below:

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

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

 

2)          Do not contain Graphene Oxide (GO) nanoparticles or similar
scanning and toxic material. And if it contains GO (and yet not listed as
its ingredients) will that affect its EUA status?

A list of ingredients is provided in the Summary of Product
Characteristics for each vaccine. None of vaccines contain graphene oxide
or any other similar scanning and toxic material.

 

3)          Its ADRs are not related for about 75% to Bleeding, Clotting
and Ischaemic fatalities. And what is the evidence for to state that said
reported vaccine s ADRs are not related to its biodistribution?

The MHRA continually monitors the safety of COVID-19 vaccines available in
the UK.  A weekly summary of Yellow Card reporting is published by the
MHRA.  These reports can be found at
[7]https://www.gov.uk/government/publicatio...

 

When interpreting spontaneous adverse event reports it is important to be
aware that suspected ADRs should not be interpreted as being proven side
effects of COVID-19 vaccines. Some events may have happened anyway,
regardless of vaccination. This is particularly the case when millions of
people are vaccinated, and especially when vaccines are being given to the
most elderly people and people who have underlying illness.

 

All vaccines and medicines have some side effects. These side effects need
to be continuously balanced against the expected benefits in preventing
illness. Following widespread use of these vaccines across the UK, the
vast majority of suspected adverse reaction reports so far confirm the
safety profile seen in clinical trials. Most reports relate to
injection-site reactions (sore arm for example) and generalised symptoms
such as a flu-like illness, headache, chills, fatigue, nausea, fever,
dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these
reactions are not associated with more serious illness and likely reflect
an expected, normal immune response to the vaccines. Cases of an extremely
rare specific type of blood clot with low blood platelets continue to be
investigated and updated advice has been provided.

 

The benefits of the vaccines in preventing COVID-19 and serious
complications associated with COVID-19 far outweigh any currently known
side effects. As with all vaccines and medicines, the safety of COVID-19
vaccines is continuously monitored and benefits and possible risks remain
under review.

 

The MHRA continually monitors the safety of COVID-19 vaccines available in
the UK.  A weekly summary of Yellow Card reporting is published by the
MHRA.  These reports can be found at
[8]https://www.gov.uk/government/publicatio...

 

When interpreting spontaneous adverse event reports it is important to be
aware that suspected ADRs should not be interpreted as being proven side
effects of COVID-19 vaccines. Some events may have happened anyway,
regardless of vaccination. This is particularly the case when millions of
people are vaccinated, and especially when vaccines are being given to the
most elderly people and people who have underlying illness.

 

All vaccines and medicines have some side effects. These side effects need
to be continuously balanced against the expected benefits in preventing
illness. Following widespread use of these vaccines across the UK, the
vast majority of suspected adverse reaction reports so far confirm the
safety profile seen in clinical trials. Most reports relate to
injection-site reactions (sore arm for example) and generalised symptoms
such as a flu-like illness, headache, chills, fatigue, nausea, fever,
dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these
reactions are not associated with more serious illness and likely reflect
an expected, normal immune response to the vaccines. Cases of an extremely
rare specific type of blood clot with low blood platelets continue to be
investigated and updated advice has been provided.

 

The benefits of the vaccines in preventing COVID-19 and serious
complications associated with COVID-19 far outweigh any currently known
side effects. As with all vaccines and medicines, the safety of COVID-19
vaccines is continuously monitored and benefits and possible risks remain
under review.

 

 

 

4)          Its Good Laboratory Practices (GLP) were diligently verified
by MHRA. And if not; then why is there of said vaccines no a
risk-benefit analysis? And its genotoxicity data were fully provided to
MHRA. And if not; will that affect its EUA?

All authorised vaccines presented non-clinical data from authorised
non-clinical sites that work within Good Laboratory Practice (GLP)
principles. Compliance with GLP was considered by the MHRA in its reviews.
All non-clinical safety studies that were required to be conducted
according to GLP were in compliance.

No genotoxicity studies were provided for the Pfizer-BioNTech and
Oxford-AstraZeneca COVID-19 vaccines in line with relevant guidance
considering their components and short duration of use. The published MHRA
and EU CHMP assessment reports provide more details and concluded the
benefit-risk analysis was positive for the vaccines.

 

 

5)          Its NNTV to prevent one COVID-case is not between 200 700, and
its NNTV to prevent one COVID-death is not 9000 or more doses. And for
each death prevented by vaccination; how many deaths and terminal injuries
inflicted by vaccination will cause its EUA to be withdrawn?

 

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. In accordance with this definition and as we have shown through
the information we have published, all authorised vaccines are effective
in the prevention of Covid-19 infection, and reduced the number of
hospitalisations and deaths that occur.

 

Four COVID-19 vaccines have now been approved for use in the UK.  Rigorous
clinical trials have been undertaken to understand the immune response,
safety profile and efficacy of these vaccines as part of the regulatory
process. Ongoing monitoring of the vaccines ensures their safety, quality
and efficacy. The benefits of the vaccines in preventing COVID-19 and
serious complications associated with COVID-19 far outweigh any currently
known side effects.

 

Studies linking community COVID-19 testing data, vaccination data and
mortality data indicate that both the Pfizer-BioNTech and
Oxford-AstraZeneca vaccines are around 70 to 85% effective at preventing
death with COVID-19 after a single dose. Vaccine effectiveness against
mortality with 2 doses of the Pfizer vaccine is around 95 to 99% and with
2 doses of the AstraZeneca vaccine around 75 to 99% (week 26 Vaccine
Surveillance Report 
[9]https://www.gov.uk/government/publicatio...
). Public Health England (PHE) estimates that 60,000 deaths and 22,057,000
infections have been prevented as a result of the COVID-19 vaccination
programme, up to 23 July. This is based on modelling analysis from PHE and
Cambridge University s MRC Biostatistics Unit (see
[10]https://www.gov.uk/government/publicatio...
).

 

 

6)          Its deaths are not certified as Covid-deaths, and its future
number of deaths is not aimed to realise the zero carbon-dioxide (CO2)
output in 2050 or the depopulation agenda of Bill Gates, the World
Economic Forum, the WHO, and UN.

MHRA does not recognise or have information concerning any aim to realise
the zero carbon-dioxide (CO2) output in 2050 or the depopulation agenda of
Bill Gates, the World Economic Forum, the WHO and the UN and to suggest
that we would authorise any vaccine to realise such ambitions is utterly
offensive and wrong.

 

7)          Its risk-benefit analysis has been published to fulfil MHRA
duty to facilitate an informed consent.

The assessment of all the vaccines that have been performed by the MHRA
and the European Medicines Agency (EMA) have been published on our
respective websites for information of how we authorised these vaccines.

 

 

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
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Please remember to quote the reference number above in any future
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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:

 

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Yours sincerely

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

 

 

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This message has been hidden. Significant extraneous non-FOI correspondence removed. The authority treated this correspondence as a request for internal review. If you are the requester, then you may sign in to view the message. Please contact us if you have any questions.

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 21/785
 
Dear Bartholomeus Lakeman,
 
Thank you for your email.
 
We confirm that an internal review will be carried out on FOI 21/785. 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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Bartholomeus Lakeman,

 

We have re-reviewed your email of 14 August, 22:31 and on reflection we do
not consider this to be a request for an internal review.

 

We regularly update our website with information about our work on
Covid-19. This information can be found at the link below:

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

 

Kind regards,

 

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