Criteria and process for determining adverse event of special interest (AESI)
Tess McCawe made this Official Information request to Ministry of Health
The request was refused by Ministry of Health.
From: Tess McCawe
Dear Ministry of Health,
You have confirmed by letter to me dated 4th November 2021 that Adverse Event 9128 was reported to MoH as serious and medically significant. You have advised that AE9128 was not categorized because it was not considered to be of special interest. Please send me all documentation relevant to the process and criteria used to determine that AE9128 is not of special interest.
Yours faithfully,
Tess McCawe
From: OIA Requests
Kia ora,
Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.
Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...
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
here: [2]http://www.ombudsman.parliament.nz/
If you have any questions while we're processing your request, please let
us know via [3][email address]
Ngā mihi
OIA Services Team
[4]Ministry of Health information releases
[5]Unite against COVID-19
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From: OIA Requests
Kia ora Tess,
Thank you for your request for official information. The Ministry's
reference number for your request is: H202115491
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: Tess McCawe <[FOI #17452 email]>
Sent: Thursday, 4 November 2021 6:38 pm
To: OIA Requests <[email address]>
Subject: Official Information request - Criteria and process for
determining adverse event of special interest (AESI)
Dear Ministry of Health,
You have confirmed by letter to me dated 4th November 2021 that Adverse
Event 9128 was reported to MoH as serious and medically significant. You
have advised that AE9128 was not categorized because it was not considered
to be of special interest. Please send me all documentation relevant to
the process and criteria used to determine that AE9128 is not of special
interest.
Yours faithfully,
Tess McCawe
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
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[3][FOI #17452 email]
Is [4][Ministry of Health request email] the wrong address for Official Information
requests to Ministry of Health? If so, please contact us using this form:
[5]https://scanmail.trustwave.com/?c=15517&...
Disclaimer: This message and any reply that you make will be published on
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From: OIA Requests
Kia ora Tess,
Please find attached a response to your official information act request.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
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From: Tess McCawe
Dear OIA Requests,
I have not been provided with the information I requested. I asked specifically for the decision making criteria for how MoH changed the information related to the reaction I had to the vaccine which was reported by a health professional who was there as “medically significant “ and “serious”. MoH have changed my record to other categories which were not experienced by me. MoH created a new form with a new number and new information and not provided it. As I lay on the chemist floor, the defibrillator was out and ambulance called because of my heart symptoms. MoH has denied that this happened. The “significant and prolonged shaking” was described as very uncommon but MoH have said it is common. MoH have not provided me with the information requested which is the criteria and process they used to change my medical records.
As MoH’s false records will be used to deny me an exemption, I want to know how they explain changing my records.
Yours sincerely,
Tess McCawe
From: OIA Requests
Kia ora,
Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.
Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...
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
here: [2]http://www.ombudsman.parliament.nz/
If you have any questions while we're processing your request, please let
us know via [3][email address]
Ngā mihi
OIA Services Team
[4]Ministry of Health information releases
[5]Unite against COVID-19
****************************************************************************
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From: OIA Requests
Kia ora Tess,
Thank you for your follow up request for information, received 25 November
2021, for:
“I have not been provided with the information I requested. I asked
specifically for the decision making criteria for how MoH changed the
information related to the reaction I had to the vaccine which was
reported by a health professional who was there as “medically significant
“ and “serious”. MoH have changed my record to other categories which were
not experienced by me. MoH created a new form with a new number and new
information and not provided it. As I lay on the chemist floor, the
defibrillator was out and ambulance called because of my heart symptoms.
MoH has denied that this happened. The “significant and prolonged shaking”
was described as very uncommon but MoH have said it is common. MoH have
not provided me with the information requested which is the criteria and
process they used to change my medical records.
As MoH’s false records will be used to deny me an exemption, I want to
know how they explain changing my records.”
The Ministry would like to provide you with a copy of your reported AEFI
as part of the response to your request. However, this report contains
detailed personal information that you may not wish to be published on
[1]www.fyi.org.nz/. If you are able to provide us with a private email
address, then we will send you this report separately to the response
letter.
We look forward to hearing from you.
Ngâ mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [2][email address]
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From: Tess McCawe
Dear OIA Requests,
I have asked for the process and criteria for MoH determining that AE 9128 (which was reported as serious and medically significant) was changed by MoH to not needing to be classified. You have told me my reaction was not classified. You have refused to provide me with any explanation of the process and criteria used.
You have asked for my email address but not advised who I should send it to. Please provide a name and email address.
Yours sincerely,
Tess McCawe
From: OIA Requests
Kia ora,
Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.
Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...
Please be advised that due dates for requests received from 29 November
2021 onwards take into account the following periods:
Christmas (25 December 2021)
Summer Holidays (25 December to 15 January)
New Year's Day (1 January 2022)
Day after News Year's Day (2 January 2022)
If you'd like to calculate the due date for your request, you can use the
Ombudsman's online calculator here: [2]http://www.ombudsman.parliament.nz/
If you have any questions while we're processing your request, please let
us know via [3][email address]
Ngā mihi
OIA Services Team
[4]Ministry of Health information releases
[5]Unite against COVID-19
****************************************************************************
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From: OIA Requests
Kia ora Tess,
The Ministry is in the process of responding to your request. Part of this
response involves providing you with a copy of your AEFI report.
You can provide us with your email address by either replying to this
email or by sending a new email to [email address] with your
reference number in the subject line (ref: H202115491).
You can expect a response to your request no later than 23 December 2021,
being 20 days after you submitted your request.
We look forward to hearing from you.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
--------------------------------------------------------------------------
From: Tess McCawe <[FOI #17452 email]>
Sent: Thursday, 9 December 2021 15:50
To: OIA Requests <[email address]>
Subject: Re: Your request for official information (ref_H202115491)
Dear OIA Requests,
I have asked for the process and criteria for MoH determining that AE 9128
(which was reported as serious and medically significant) was changed by
MoH to not needing to be classified. You have told me my reaction was not
classified. You have refused to provide me with any explanation of the
process and criteria used.
You have asked for my email address but not advised who I should send it
to. Please provide a name and email address.
Yours sincerely,
Tess McCawe
-----Original Message-----
Kia ora Tess,
Thank you for your follow up request for information, received 25
November
2021, for:
“I have not been provided with the information I requested. I asked
specifically for the decision making criteria for how MoH changed the
information related to the reaction I had to the vaccine which was
reported by a health professional who was there as “medically significant
“ and “serious”. MoH have changed my record to other categories which
were
not experienced by me. MoH created a new form with a new number and new
information and not provided it. As I lay on the chemist floor, the
defibrillator was out and ambulance called because of my heart symptoms.
MoH has denied that this happened. The “significant and prolonged
shaking”
was described as very uncommon but MoH have said it is common. MoH have
not provided me with the information requested which is the criteria and
process they used to change my medical records.
As MoH’s false records will be used to deny me an exemption, I want to
know how they explain changing my records.”
The Ministry would like to provide you with a copy of your reported AEFI
as part of the response to your request. However, this report contains
detailed personal information that you may not wish to be published on
[http://scanmail.trustwave.com/?c=15517&a...
If you are able to provide us with a private email
address, then we will send you this report separately to the response
letter.
We look forward to hearing from you.
Ngâ mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [2][email address]
References
Visible links
1.
[2]http://scanmail.trustwave.com/?c=15517&a...
2. [3]mailto:[email address]
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #17452 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[4]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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victor left an annotation ()
Tess , if you could continue to provide updates on this important discussion on aspects which happen outside of visibility such as email, into this record.
Agencies and agents are steadfastly preventing process mapping and from being discovered but slowly the pieces are being put together.
No positive reason why this is being done it can only be due to forms of 'incompetence', negligence, malfeasance and other insidious type of behaviours under instruction.
Thank you for persisting and continuing to update.
From: Tess McCawe
Dear OIA Requests,
I want to ensure there is no misunderstanding about my request. I have not requested any personal information, hence want my reply to be in this public space. I have asked for the decision making criteria and process used to determine that AE 9128 ( reported as “serious” and “medically significant” did not require classification ( as previously advised) and was not of special interest. The only document I consent to being made public is the original AE9128 that I already have a copy of. The decision making criteria and process used for all adverse event reports should be public information.
Yours sincerely,
Tess McCawe
From: OIA Requests
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Kia ora Tess,
Please find attached a response to your official information act request.
Information in Appendix 3 has been redacted to protect your personal
information from being published publicly on FYI.org. If you would like to
receive an unredacted version of this document, please email the Ministry
from your personal email address. Contact details for the Ministry can be
found here: [1]https://www.health.govt.nz/about-ministr...
[2]Contact us | Ministry of Health NZ
General enquiries. For general enquiries: email the Ministry at [email
protected]; or phone: 0800 855 066. COVID-19 queries. For COVID-19 health
advice and information, contact the Healthline team (for free) on 0800 358
5453 or +64 9 358 5453 for international SIMS. For other COVID-19-related
queries, email [email protected].
www.health.govt.nz
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [3][email address]
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From: Tess McCawe
Dear OIA Requests,
In Appendix 3 you have provided me with the evidence that form AE9128 was edited after the pharmacist sent it to CARM. I have the orignial form so I know that the paragraph under the heading “Medical History” was created later without my knowledge or permssion. My OIA request to you relates to process so I do not need to know what this person wrote and you do not have my permission for that paragraph to be shared with anyone.
In order to respond to my OIA request (which is for details of the process used to change AE9128), please provide answers to the following specific questions. (1) What was the date and time that the text placed under the paragraph headed “Medical History” was created?
The Ombudsman has provided guidance that public sector employees can be named when performing their duties, so (2) please state the name of the person who created the paragraph “Medical History” in the form AE9128. (3) Please state this person's medical qualifications and (4) the name of their employer. If they are a contractor, please (5) provide the details of their contract. (6) Please state all information sources used by this individual when they wrote the "Medical History" paragraph. Most importantly, (7) please state the specific legislation which allowed this individual to access my personal information without my knowledge or permission and / or create new information without my input or consent.
Yours sincerely,
Tess McCawe
From: OIA Requests
Kia ora Tess,
Thank you for your follow up request for official information. The
Ministry's reference number for your request is: H202117767.
Please be advised that due dates for requests received from 29 November
2021 onwards take into account the following periods:
Christmas (25 December 2021)
Summer Holidays (25 December to 15 January)
New Year's Day (1 January 2022)
Day after News Year's Day (2 January 2022)
Your request has been logged and you can expect a reply no later than 01
February 2022 as required under the Official Information Act 1982.
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: [1][email address]
-----Original Message-----
From: Tess McCawe <[FOI #17452 email]>
Sent: Tuesday, 14 December 2021 7:17 pm
To: OIA Requests <[email address]>
Subject: Re: Response to your official information act request
(ref_H202116818)
Dear OIA Requests,
In Appendix 3 you have provided me with the evidence that form AE9128 was
edited after the pharmacist sent it to CARM. I have the orignial form so
I know that the paragraph under the heading “Medical History” was created
later without my knowledge or permssion. My OIA request to you relates to
process so I do not need to know what this person wrote and you do not
have my permission for that paragraph to be shared with anyone.
In order to respond to my OIA request (which is for details of the process
used to change AE9128), please provide answers to the following specific
questions. (1) What was the date and time that the text placed under the
paragraph headed “Medical History” was created?
The Ombudsman has provided guidance that public sector employees can be
named when performing their duties, so (2) please state the name of the
person who created the paragraph “Medical History” in the form AE9128.
(3) Please state this person's medical qualifications and (4) the name of
their employer. If they are a contractor, please (5) provide the details
of their contract. (6) Please state all information sources used by this
individual when they wrote the "Medical History" paragraph. Most
importantly, (7) please state the specific legislation which allowed this
individual to access my personal information without my knowledge or
permission and / or create new information without my input or consent.
Yours sincerely,
Tess McCawe
-----Original Message-----
Kia ora Tess,
Please find attached a response to your official information act request.
Information in Appendix 3 has been redacted to protect your personal
information from being published publicly on
[2]http://scanmail.trustwave.com/?c=15517&a...
If you would like to receive an unredacted version of this document,
please email the Ministry from your personal email address. Contact
details for the Ministry can be found
here: [1][3]https://www.health.govt.nz/about-ministr...
[2]Contact us | Ministry of Health NZ
General enquiries. For general enquiries: email the Ministry at [email
protected]; or phone: 0800 855 066. COVID-19 queries. For COVID-19 health
advice and information, contact the Healthline team (for free) on 0800 358
5453 or +64 9 358 5453 for international SIMS. For other COVID-19-related
queries, email [email protected].
[4]www.health.govt.nz
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [3][email address]
References
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[8][FOI #17452 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[9]https://scanmail.trustwave.com/?c=15517&...
If you find this service useful as an Official Information officer, please
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From: OIA Requests
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Kia ora Tess,
Please find attached a response to your official information act request.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
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From: Tess McCawe
Dear OIA Requests,
I have been advised by Medsafe that "the vaccinator" created a paragraph on AE9128 after it was submitted (I have a coy of the original). MoH has advised that they do not know anything about this. As MoH say they are not "the vaccinator" please advise who is so I can contact them
Yours sincerely,
Tess McCawe
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
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. This
means we may take some time in responding to your request. The Ministry
regularly updates information about the COVID-19 situation and publishes
OIA responses considered to be of public interest:
[2]https://www.health.govt.nz/about-ministr...
Please also refer to the Unite Against Covid-19 website for copies of
papers, minutes, and key advice for the decisions the Government has made
relating to COVID-19.
Sometimes we may need to clarify aspects of a request. You can expect to
hear from us soon if that is the case here.
Ngā mihi,
OIA Services
Government Services
Office of the Director-General
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E: [3][email address]
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victor left an annotation ()
Tess the following might be of relevance to you.
- MOH contract CARM through medsafe
- MOH and Medsafe refused to disclose CARM funding and funders in OIA
- MOH and Medsafe refused to disclose access into CARM and access rights to the data input to CARM, editing data inside CARM and editing data prior to release
- Michael Tatley is a name follow up as long term minder of CARM and related
From: OIA Requests
Kia ora Tess,
Thank you for your email. Your vaccinator is the person who administered
the vaccine to you. Please contact the vaccination centre, general
practice or health professional that you received your vaccine from for
this information.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
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From: Tess McCawe <[FOI #17452 email]>
Sent: Thursday, 27 January 2022 13:24
To: OIA Requests <[email address]>
Subject: Re: Response to your official information act request
(ref_H202117767)
Dear OIA Requests,
I have been advised by Medsafe that "the vaccinator" created a paragraph
on AE9128 after it was submitted (I have a coy of the original). MoH has
advised that they do not know anything about this. As MoH say they are not
"the vaccinator" please advise who is so I can contact them
Yours sincerely,
Tess McCawe
-----Original Message-----
Kia ora Tess,
Please find attached a response to your official information act
request.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
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1. [2]mailto:[email address]
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From: Tess McCawe
Dear OIA Requests,
I have been given false information by Medsafe. They said my vaccinator created a paragraph called ‘medical history’ associated with my name. My vaccinator gave me copy of the form AE9128 a few days after I was taken to hospital. The vaccinator did not write a paragraph called ‘medical history’. I repeat my OIA question. Who entered the paragraph called ‘medical history’ on AE9128?
Yours sincerely,
Tess McCawe
From: OIA Requests
Kia ora Tess,
Thank you for your email. The Ministry has nothing further to add. Please
contact your vaccinator directly if you have further questions as
recommended in the Ministry's response.
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.
Ngā mihi
OIA Services Team
[2]Ministry of Health information releases
[3]Unite against COVID-19
--------------------------------------------------------------------------
From: Tess McCawe <[FOI #17452 email]>
Sent: Tuesday, 1 February 2022 16:02
To: OIA Requests <[email address]>
Subject: Re: Response to your official information act request
(ref_H202117767)
Dear OIA Requests,
I have been given false information by Medsafe. They said my vaccinator
created a paragraph called ‘medical history’ associated with my name. My
vaccinator gave me copy of the form AE9128 a few days after I was taken to
hospital. The vaccinator did not write a paragraph called ‘medical
history’. I repeat my OIA question. Who entered the paragraph called
‘medical history’ on AE9128?
Yours sincerely,
Tess McCawe
-----Original Message-----
Kia ora Tess,
Thank you for your email. Your vaccinator is the person who administered
the vaccine to you. Please contact the vaccination centre, general
practice or health professional that you received your vaccine from for
this information.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]
--------------------------------------------------------------------------
From: Tess McCawe <[FOI #17452 email]>
Sent: Thursday, 27 January 2022 13:24
To: OIA Requests <[email address]>
Subject: Re: Response to your official information act request
(ref_H202117767)
Dear OIA Requests,
I have been advised by Medsafe that "the vaccinator" created a paragraph
on AE9128 after it was submitted (I have a coy of the original). MoH has
advised that they do not know anything about this. As MoH say they are
not
"the vaccinator" please advise who is so I can contact them
Yours sincerely,
Tess McCawe
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #17452 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[4]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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distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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Tess McCawe left an annotation ()
MoH have refused to provide the process by which AE9128 (adverse event form) was amended after the vaccinator had provided it. The vaccinator gave me a copy of what they provided MoH. MoH have refused to explain why AE9128 (which was reported as “serious” and “medically significant “) was not considered important enough to require categorisation as an adverse event.
R Bailey left an annotation ()
Are you following up with the ombudsman? Seems pretty dodgy...
Things to do with this request
- Add an annotation (to help the requester or others)
- Download a zip file of all correspondence
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Requests for personal information and vexatious requests are not considered valid requests for Official Information (read more).
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victor left an annotation ()
https://www.globalvaccinedatanetwork.org...
Work is under way at the Department of General Practice and Primary Health Care within the University of Auckland to gather baseline data on medical events that have potential to be associated with COVID-19 vaccines.
Defining these potential Adverse Events of Special Interest (AESI) and calculating the rate at which they have occurred in New Zealand in the past are prerequisites for monitoring the safety of COVID-19 vaccines.
If these adverse events occur after a vaccine is introduced to the population, New Zealand will have a frame of reference with which to compare the rates of these events to assess if there is a safety concern or not.
The Brighton Collaboration has already defined 22 AESI
and Assoc. Prof. Helen Petousis-Harris and her team are currently gathering data to calculate the background rates of these events, with funding provided by the New Zealand
- Petousis-Harris is co-director of the GVDN and is also on the Brighton Collaboration Science Advisory board.
- Brighton is owned and controlled by BMGF and CEPI including others
- Brighton Collaboration defines and decides what is and is not AESI and then the SAFE (Auckland Uni Petousis-Harris) programme data is utilised to dismiss using unpublished formulas and calculations behind alleged rates of expected natural rates of death.
It is a closed circuit exercise in definition control, event identification control and statistical manipulation
Real lives are impacted and then dismissed behind private dictates delivered through the local implementers.
Link to this