Risk Benefit Analysis - Covid-19 Vaccine

Chuck Schooner (Account suspended) made this Official Information request to Ministry of Health

The request was partially successful.

From: Chuck Schooner (Account suspended)

Dear Ministry of Health,

Per previous Official Information Act requests I understand for the removal of an approved Medicine involves a review of the risk / benefit of the product following reported adverse affects. Medsafe's own data confirms the Covid-19 vaccine as

- Confirmed two deaths
- 154 suspicious deaths at a minimum
- Over 2,000 deaths within 21 days
- 15 serious safety signals that Medsafe continue to monitor

Various Doctors have reported the above and a brave group of Doctors have requested numerous discussions with Ministry of Health and Medsafe due to these safety issues which number in the 1,000's. As a comparison a Goree Medical Product had one report of Mercury Poisoning and was removed from market.

Can you please provide the following

- Risk / Benefit analysis of the vaccine when it was approved
- If one was not completed then why not?
- Risk / Benefit analysis of the vaccine after the death of one person was confirmed
- If one was not completed then why not?
- Risk / Benefit analysis of the vaccine after the death of a second person was confirmed
- If one was not completed then why not?
- Risk / Benefit analysis of the vaccine at today's date taking into account all of the data collected by Ministry of Health and Medsafe
- Can the Ministry of Health confirm if there are any control groups that were put in place as a way to analyse their own data - if not why not?
- Are there any provisions in the Pfizer Contract that preclude the Ministry of Health from completing Risk / Benefit analysis?
- Can you also provide the process document(s) relating to if there is a sudden death following the vaccine then what is the process for the next of kin to obtain an autopsy of the body
- Can you also provide an update on the death of the 13 year old last year and what process has been followed in an attempt to determine the child's death

Yours faithfully,
Chuck

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From: OIA Requests

Thank you for your Official Information Act request. This is
an automatic reply to let you know we received it.

In accordance with the Act, we'll let you know our decision within no more
than 20 working days. If you'd like to calculate the timeframe, you can
use the Ombudsman's online calculator
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From: OIA Requests


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Kia ora Chuck,

 

Thank you for your request for official information. The Ministry's
reference number for your request is: H202205215.

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame.

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [2][email address]

 

-----Original Message-----
From: Chuck Schooner <[FOI #19080 email]>
Sent: Thursday, 7 April 2022 11:58 am
To: OIA Requests <[email address]>
Subject: Official Information request - Risk Benefit Analysis - Covid-19
Vaccine

 

Dear Ministry of Health,

 

Per previous Official Information Act requests I understand for the
removal of an approved Medicine involves a review of the risk / benefit of
the product following reported adverse affects.  Medsafe's own data
confirms the Covid-19 vaccine as

 

- Confirmed two deaths

- 154 suspicious deaths at a minimum

- Over 2,000 deaths within 21 days

- 15 serious safety signals that Medsafe continue to monitor

 

Various Doctors have reported the above and a brave group of Doctors have
requested numerous discussions with Ministry of Health and Medsafe due to
these safety issues which number in the 1,000's.  As a comparison a Goree
Medical Product had one report of Mercury Poisoning and was removed from
market.

 

Can you please provide the following

 

- Risk / Benefit analysis of the vaccine when it was approved

- If one was not completed then why not?

- Risk / Benefit analysis of the vaccine after the death of one person was
confirmed

- If one was not completed then why not?

- Risk / Benefit analysis of the vaccine after the death of a second
person was confirmed

- If one was not completed then why not?

- Risk / Benefit analysis of the vaccine at today's date taking into
account all of the data collected by Ministry of Health and Medsafe

- Can the Ministry of Health confirm if there are any control groups that
were put in place as a way to analyse their own data - if not why not?

- Are there any provisions in the Pfizer Contract that preclude the
Ministry of Health from completing Risk / Benefit analysis?

- Can you also provide the process document(s) relating to if there is a
sudden death following the vaccine then what is the process for the next
of kin to obtain an autopsy of the body

- Can you also provide an update on the death of the 13 year old last year
and what process has been followed in an attempt to determine the child's
death

 

Yours faithfully,

Chuck

 

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Kia ora Chuck, 
Please find attached your request for official information.

Ngā mihi

 

OIA Services Team

 

[1]Ministry of Health information releases

[2]Unite against COVID-19

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Erika Whittome left an annotation ()

Gosh is this our democratic government denying to share details? Or is this the secret state security masquerading as medicine and health.

In the former German "Democratic" Republic (East Germany) it was called "Die Staatsversicherung", which means state security or "Die Stasi" for short.

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From: Chuck Schooner (Account suspended)

Dear OIA Requests / Astrid,

Another OIA, another day where MOH does not have the required information or won’t provide it. So transparent!!
Can you confirm if it is normal practice for a Cost / Benefit analysis to be completed if a person dies from an approved medicine - I understand it is?
Yes or No?

Yours sincerely,

Chuck Schooner

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From: OIA Requests


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Kia ora Chuck,  

  

Thank you for your request for official information received on 11 May
2022 for: 

  

"Can you confirm if it is normal practice for a Cost / Benefit analysis to
be completed if a person dies from an approved medicine" 

  

The Ministry's reference number for your request is: H202206245.  

  

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 9 June 2022, being 20
working days after the day your request was received. 

  

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame. 

  

If you have any queries related to this request, please do not hesitate to
get in touch. 

Ngā mihi

 

OIA Services Team

 

[1]Ministry of Health information releases

[2]Unite against COVID-19

--------------------------------------------------------------------------

From: Chuck Schooner <[FOI #19080 email]>
Sent: Wednesday, 11 May 2022 17:02
To: OIA Requests <[email address]>
Subject: Re: Your request for official information (ref:H202205215)
 
Dear OIA Requests / Astrid,

Another OIA, another day where MOH does not have the required information
or won’t provide it.  So transparent!!
Can you confirm if it is normal practice for a Cost / Benefit analysis to
be completed if a person dies from an approved medicine - I understand it
is?
Yes or No?

Yours sincerely,

Chuck Schooner

-----Original Message-----

Kia ora Chuck, 
 Please find attached your request for official information.

 Ngā mihi

  

 OIA Services Team

  

 [1]Ministry of Health information releases

 [2]Unite against COVID-19
 
 
References

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-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #19080 email]

Disclaimer: This message and any reply that you make will be published on
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[5]https://scanmail.trustwave.com/?c=15517&...

If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.

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Virginia Crawford left an annotation ()

Don't forget that under Section 20(3) of the Medicines Act:

No consent given under this section shall be deemed to warrant the safety or efficacy of the medicine to which the consent relates.

Even though we are constantly being told that the vaccine is "safe and effective".

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Kia ora Chuck,  

 

Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health (the Ministry) on 11 May 2022 for: 

 

“Can you confirm if it is normal practice for a Cost / Benefit analysis to
be completed if a person dies from an approved medicine.” 

 

Medsafe does not perform a cost-benefit analysis when a person dies from
an approved medicine. The cost of a medicine does not figure into
Medsafe’s deliberations.  

 

Under section 28(3) of the Act, you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [1][email address] or by calling 0800
802 602. 

 

Ngâ mihi

 

OIA Services Team

 

[2]Ministry of Health information releases

[3]Unite against COVID-19

 

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From: Chuck Schooner (Account suspended)

Dear OIA Requests,

I am a little confused and can't quite work out if I am getting lied to, MOH is cutting corners or Pfizer have a different deal than other approved medicines. And please note I require a "Risk / Benefit" analysis - not a cost / benefit analysis.

A previous OIA request submitted here the response from Medsafe stated "The process for removal of an approved medicine from market is different. It involves a review of the risk-benefit of the product following reported adverse events where a signal is identified that the product has potential for harm".

https://fyi.org.nz/request/18035/respons...

To date, the Pfizer vaccine has caused

- 4 deaths confirmed with 100's of suspect deaths
- 18 safety signals
- 200,000 plus entries into CARM including disability, heart issues and miscarriage

Am I correct in saying that despite all of these reactions a risk / benefit analysis has never been done?
If a risk benefit analysis has not been done then why not when this was what happened with the withdrawal of Reductil? https://www.medsafe.govt.nz/hot/media/20...
Given the countless injuries and deaths then why has a risk / benefit analysis not been done after each and every serious report to CARM?
Are there different rules for Pfizer?
Given the vaccine does not prevent or stop transmission and nobody can tell me the differences of Covid symptons with or without the vaccine then it appears the benefit of this gene therapy are modest if any
Why following countless adverse events has a risk / benefit analysis not been done?

Yours sincerely,

Chuck Schooner

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From: OIA Requests


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Kia ora Chuck,  

  

Thank you for your request for official information received on 26 May
2022 for: 

  

"Am I correct in saying that despite all of these reactions a risk /
benefit analysis has never been done?

If a risk benefit analysis has not been done then why not when this was
what happened with the withdrawal of
Reductil? https://www.medsafe.govt.nz/hot/media/20...
Given the countless injuries and deaths then why has a risk / benefit
analysis not been done after each and every serious report to CARM?
Are there different rules for Pfizer?
Why following countless adverse events has a risk / benefit analysis not
been done?" 

  

The Ministry's reference number for your request is: H202207006.  

  

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 27 June 2022, being 20
working days after the day your request was received. 

  

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame. 

  

If you have any queries related to this request, please do not hesitate to
get in touch. 

OIA Services Team

 

[1]Ministry of Health information releases

[2]Unite against COVID-19

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Kia Ora Chuck,  

 

Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health (the Ministry) on 26 May 2022 for:  

 

“Am I correct in saying that despite all of these reactions a risk /
benefit analysis has never been done? 

If a risk benefit analysis has not been done then why not when this was
what happened with the withdrawal of
Reductil? https://www.medsafe.govt.nz/hot/media/20...

Given the countless injuries and deaths then why has a risk / benefit
analysis not been done after each and every serious report to CARM? 

Are there different rules for Pfizer?  

Why following countless adverse events has a risk / benefit analysis not
been done?”
 

The clinical evaluation report which is the benefit risk assessment is
publicly available at:
[1]www.health.govt.nz/about-ministry/information-releases/responses-official-information-act-requests?year=2022.There
have been three deaths possibly related to COVID-19 vaccination that are
awaiting the coroner to confirm. More deaths have been reported due to the
COVID-19 infection, updates are available at:
[2]www.health.govt.nz/covid-19-novel-coronavirus/covid-19-data-and-statistics/covid-19-case-demographics#deaths.The
COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) have
reviewed all significant reports and signals and have confirmed that they
do not consider these to have impacted the benefit risks for covid-19
vaccines.  

 

The vast majority of reported Adverse Events Following Immunisation
(AEFIs) are minor expected events such as headache and sore arm. These
types of events are expected for all vaccines and are not material to the
benefit risk. The COVID-19 vaccine is of value as it continues to lower
the risk of hospitalisation than unvaccinated people. No medicines
regulator has considered that any COVID-19 vaccine has an unfavourable
benefit risk.  

 

I trust this information fulfils your request. Under section 28(3) of the
Act, you have the right to ask the Ombudsman to review any decisions made
under this request. The Ombudsman may be contacted by email at:
[3][email address] or by calling 0800 802 602. 

Please note that this response, with your personal details removed, may be
published on the Ministry website at:
[4]www.health.govt.nz/about-ministry/information-releases/responses-official-information-act-requests.
 

 

Ngâ mihi 

  

OIA Services Team 

  

[5]Ministry of Health information releases 

[6]Unite against COVID-19 

 

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Virginia Crawford left an annotation ()

Absolutely unbelievable response! Complete and utter nonsense!

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