CV-ISMB Memos & Associated Information
Chris McCashin made this Official Information request to Ministry of Health
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From: Chris McCashin
Dear Ministry of Health,
MOH has recently dropped a number of Memo's completed by CV-ISMB on 2nd August. I have reviewed the Memo's and I have the following queries, follow ups.
7 May 2021 - Memo
This memo mentions there were three general meetings prior to this date (last meeting 29 April) and an ad-hoc meeting (22 April) to look at blood clotting/bleeding effects from some of the Covid-19 vaccines reported overseas.
Ad hoc meeting to discuss thrombosis with thrombocytopenia (TTS).
Please provide all of the memo's prior to 7 May 2021 including all of the ad-hoc meeting memos completed by the CV-ISMB.
The memo also notes "it would be beneficial to provide information on this clotting/bleeding syndrome for the public, and in that case what communication would be needed"
Please provide all of the ways, mediums, advertising, warnings from vaccinators that were provided to the public notifying them of potential clotting/bleeding? As at todays date, what has been provided to public to warn them of this side effect?
The Memo Mentioned anaphylaxis is currently 8/260,000. Members mentioned these numbers might end up being spuriously high and should be assessed against Brighton Collaboration
Please provide total number of anaphylaxis cases following vaccination in two data sets.
Total Anaphylaxis following vaccine
Total Anaphylaxis reported against Brighton Collaboration
Reporting against Brighton Collaboration will dilute the numbers will it not? Why with a new treatment with no vaccine data would all of the reports be recorded? Unless not to mislead the public?
At the time there were three potential safety signals under investigation. This was May 2021 - why weren't people warned of these "noted" safety signals - just because they weren't confirmed surely the public have a right to know by vaccinator, informed consent that CV-ISMB are already monitoring safety signals? Please note myocarditis numbers using 2019 as a baseline show an over 900% increase based on recorded AEFI's.
8 July 2021 - Memo - as alluded to above - PLEASE PROVIDE ALL MEMOS
Menstrual Irregularities - Given the menstruation cycle is directly related to fertility surely this is a red flag and woman should have been provided a warning about potential menstrual irregularities - what monitoring, memos, warnings, addition to product label were added to vaccine notifying people of potential menstrual irregularities?
This memo mentions Medsafe presented an update on Myocarditis - please provide the minutes / memo associated with what Medsafe presented to CV-ISMB - who, when, what was involved when Medsafe presented to CV-ISMB associated with Myocarditis - please provide the slides from this presentation.
This memo mentions all reports of death up until 24th June have been presented to CV-ISMB with a number of deaths in the frail and elderly. The CV-ISMB commented that there is a need to be careful attributing death to "natural causes" in the frail elderly, as
they can pass away from mild external stress, such as vaccination.
This acknowledges a "causal" link between vaccination and death - it mentions that vaccinating the elderly was due to be considered by the Covid-19 Vaccine Technical Advisory was considering this - please provide any and all information, memos, notes, studies that this group looked at when considering whether or not to continue vaccinating the elderly? I require the meeting notes and memo associated with this meeting.
12 August 2021 - Memo
Please provide the "expert opinion" completed by Ralph Stewart cardiologist
This memo mentions the benefits continue to outweigh the risks - please provide the benefit / risk assessment that was used to support the statement from the board?
17 September 2021 - Memo
Please provide the "expert opinion" completed by Dr Laura Young
It appears the death was put down to another drug - again the benefits continue to outweigh the risks - please provide an updated benefit / risk assessment that supports the statement by the board?
4 October 2021 - Memo
This memo mentions under reporting - so the CV-ISMB knows that under reporting relates to vaccine injuries - please provide what the CV-ISMB has to support how under reported vaccine injuries are - what studies show the rate of vaccine injury under reporting?
12. Please provide the communications that went out to Clinicians, Cardiologists and Pathologists as per point 12 of this memo
11 October 2021 - Memo
10. Please provide the papers, memos, reporting completed by Medsafe / CV-ISMB regarding Myocarditis and the publishable deliverables mentioned by this Memo.
11. Vaccination in Pregnancy - Please provide all of the data associated with pregancies, congenital abnormalities and the ongoing work associated? Is it not a bit late to review abnormalities when they could have been avoided without vaccine?
13 December 2021 - Memo
4. Only 2 of 3 referred to Coroner - why was the third case not referred to Coroner? Previous OIA requests say Medsafe / Carm do not investigate deaths - this mentions the case was reported to CARM - why not the Coroner?
9. Please provide the memo of the call with UK Medicines on Friday 9 December 2021 discussing fatal cases of myocarditis in UK? Surely people dying globally requires the vaccine to be stopped? There was no doubt at this stage that people are dying all over the world?
10. Please provide the update by Medsafe to the board including slides of myocarditis in New Zealand.
The communication again mentions benefits outweigh the risks - please provide the risk / benefit analysis that was used to support this statement?
11. ii - Please provide any and all communications made to public, vaccinators etc warning of Myocarditis - as at this date please confirm verbal & written information vaccinators are required to convey to someone receiving the vaccine to ensure they have informed consent?
Recent social media shows Pharmacists are not verbally warning of risks
12. Board did not raise benefit / risk balance, please provide the benefit risk balance being relied on?
15. Please provide Appendix 1 of this memo
25 February 2022 - Memo
6. Please provide the interim report completed by the CV-ISMB with the boards findings.
9. As alluded to above, not all memos have been provided - please provide all of these
9. Eighteen safety signals have been considered with 28 Recommendations - please provide all of the 28 Recommendations
9. Only one safety signal has been confirmed - this was added to the product label - please provide exactly what was added to the product label? Are the general public warned of what is on the product label? Please provide the current product label
10. Please provide international and NZ data presented that the vaccine is "very safe vaccine" as per this statement - any and all Post Marketing studies
11. As alluded to above - please provide the interim report
25 February 2022 - Memo
5. Please provide the recommendation from the WHO for the appointment of these people to the oversight committee? Why are the WHO providing recommendations to NZ oversight committees?
6. Appears memos are missing from 26 January and 9 February - as alluded to above I want all of the memos - please provide these
9. Please provide the memos presented to the board for booster doses for 5 - 11 year olds?
17. Please provide all "Extraordinary Meeting Memos" - personal information can be redacted
18. Please provide what "written information" was requested from the Pathologist - Please provide the terms of service for the pathologist ie what additional information are they providing to the CV-ISMB and the cost associated.
8 March 2022 - Memo
4. Please provide the study used to evaluate the effect of the Pfizer vaccine on thrombotic events
5. Coroner said death did not need to be investigated by them - please provide the communications to the CV-ISMB from the coroner with justification as to why coroner did not want to investigate
16. Again, benefits outweigh the risks - please provide the risk benefit analysis that the CV-ISMB relied on
17. Please provide the study of thrombotic events as per section 17 - 20.
24. Please provide the minutes as Appendix 2.
8 March 2022 - Memo
Please link me to where all the CV-ISMB meeting minutes are at
18 March 2022 - Memo
9. Please provide Medsafes "regular" updates on Myocarditis, Pericarditis in NZ - please provide all slides, data associated
10. Please provide all work associated with Post Partum congenital abnormalities, documents associated / work completed by Medsafe?
Again - isn't this a bit late - pregnant woman are warned away from mayonnaise yet they were recommended this gene therapy that the Ministry of Health is still unable to produce or quantify any of the benefits associated with this therapy.
Yours faithfully,
Chris
From: OIA Requests
Kia ora Chris,
Thank you for your request for official information. The Ministry's
reference number for your request is: H2022010003.
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U[3]nite against COVID-19
------------------- Original Message -------------------
From: Chris McCashin <[FYI request #20204 email]>;
Received: Thu Aug 11 2022 12:49:34 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - CV-ISMB Memos & Associated
Information
Dear Ministry of Health,
MOH has recently dropped a number of Memo's completed by CV-ISMB on 2nd
August. I have reviewed the Memo's and I have the following queries,
follow ups.
7 May 2021 - Memo
This memo mentions there were three general meetings prior to this date
(last meeting 29 April) and an ad-hoc meeting (22 April) to look at blood
clotting/bleeding effects from some of the Covid-19 vaccines reported
overseas.
Ad hoc meeting to discuss thrombosis with thrombocytopenia (TTS).
Please provide all of the memo's prior to 7 May 2021 including all of the
ad-hoc meeting memos completed by the CV-ISMB.
The memo also notes "it would be beneficial to provide information on this
clotting/bleeding syndrome for the public, and in that case what
communication would be needed"
Please provide all of the ways, mediums, advertising, warnings from
vaccinators that were provided to the public notifying them of potential
clotting/bleeding? As at todays date, what has been provided to public to
warn them of this side effect?
The Memo Mentioned anaphylaxis is currently 8/260,000. Members mentioned
these numbers might end up being spuriously high and should be assessed
against Brighton Collaboration
Please provide total number of anaphylaxis cases following vaccination in
two data sets.
Total Anaphylaxis following vaccine
Total Anaphylaxis reported against Brighton Collaboration
Reporting against Brighton Collaboration will dilute the numbers will it
not? Why with a new treatment with no vaccine data would all of the
reports be recorded? Unless not to mislead the public?
At the time there were three potential safety signals under
investigation. This was May 2021 - why weren't people warned of these
"noted" safety signals - just because they weren't confirmed surely the
public have a right to know by vaccinator, informed consent that CV-ISMB
are already monitoring safety signals? Please note myocarditis numbers
using 2019 as a baseline show an over 900% increase based on recorded
AEFI's.
8 July 2021 - Memo - as alluded to above - PLEASE PROVIDE ALL MEMOS
Menstrual Irregularities - Given the menstruation cycle is directly
related to fertility surely this is a red flag and woman should have been
provided a warning about potential menstrual irregularities - what
monitoring, memos, warnings, addition to product label were added to
vaccine notifying people of potential menstrual irregularities?
This memo mentions Medsafe presented an update on Myocarditis - please
provide the minutes / memo associated with what Medsafe presented to
CV-ISMB - who, when, what was involved when Medsafe presented to CV-ISMB
associated with Myocarditis - please provide the slides from this
presentation.
This memo mentions all reports of death up until 24th June have been
presented to CV-ISMB with a number of deaths in the frail and elderly.
The CV-ISMB commented that there is a need to be careful attributing death
to "natural causes" in the frail elderly, as
they can pass away from mild external stress, such as vaccination.
This acknowledges a "causal" link between vaccination and death - it
mentions that vaccinating the elderly was due to be considered by the
Covid-19 Vaccine Technical Advisory was considering this - please provide
any and all information, memos, notes, studies that this group looked at
when considering whether or not to continue vaccinating the elderly? I
require the meeting notes and memo associated with this meeting.
12 August 2021 - Memo
Please provide the "expert opinion" completed by Ralph Stewart
cardiologist
This memo mentions the benefits continue to outweigh the risks - please
provide the benefit / risk assessment that was used to support the
statement from the board?
17 September 2021 - Memo
Please provide the "expert opinion" completed by Dr Laura Young
It appears the death was put down to another drug - again the benefits
continue to outweigh the risks - please provide an updated benefit / risk
assessment that supports the statement by the board?
4 October 2021 - Memo
This memo mentions under reporting - so the CV-ISMB knows that under
reporting relates to vaccine injuries - please provide what the CV-ISMB
has to support how under reported vaccine injuries are - what studies show
the rate of vaccine injury under reporting?
12. Please provide the communications that went out to Clinicians,
Cardiologists and Pathologists as per point 12 of this memo
11 October 2021 - Memo
10. Please provide the papers, memos, reporting completed by Medsafe /
CV-ISMB regarding Myocarditis and the publishable deliverables mentioned
by this Memo.
11. Vaccination in Pregnancy - Please provide all of the data associated
with pregancies, congenital abnormalities and the ongoing work associated?
Is it not a bit late to review abnormalities when they could have been
avoided without vaccine?
13 December 2021 - Memo
4. Only 2 of 3 referred to Coroner - why was the third case not referred
to Coroner? Previous OIA requests say Medsafe / Carm do not investigate
deaths - this mentions the case was reported to CARM - why not the
Coroner?
9. Please provide the memo of the call with UK Medicines on Friday 9
December 2021 discussing fatal cases of myocarditis in UK? Surely people
dying globally requires the vaccine to be stopped? There was no doubt at
this stage that people are dying all over the world?
10. Please provide the update by Medsafe to the board including slides of
myocarditis in New Zealand.
The communication again mentions benefits outweigh the risks - please
provide the risk / benefit analysis that was used to support this
statement?
11. ii - Please provide any and all communications made to public,
vaccinators etc warning of Myocarditis - as at this date please confirm
verbal & written information vaccinators are required to convey to someone
receiving the vaccine to ensure they have informed consent?
Recent social media shows Pharmacists are not verbally warning of risks
12. Board did not raise benefit / risk balance, please provide the
benefit risk balance being relied on?
15. Please provide Appendix 1 of this memo
25 February 2022 - Memo
6. Please provide the interim report completed by the CV-ISMB with the
boards findings.
9. As alluded to above, not all memos have been provided - please provide
all of these
9. Eighteen safety signals have been considered with 28 Recommendations -
please provide all of the 28 Recommendations
9. Only one safety signal has been confirmed - this was added to the
product label - please provide exactly what was added to the product
label? Are the general public warned of what is on the product label?
Please provide the current product label
10. Please provide international and NZ data presented that the vaccine
is "very safe vaccine" as per this statement - any and all Post Marketing
studies
11. As alluded to above - please provide the interim report
25 February 2022 - Memo
5. Please provide the recommendation from the WHO for the appointment of
these people to the oversight committee? Why are the WHO providing
recommendations to NZ oversight committees?
6. Appears memos are missing from 26 January and 9 February - as alluded
to above I want all of the memos - please provide these
9. Please provide the memos presented to the board for booster doses for
5 - 11 year olds?
17. Please provide all "Extraordinary Meeting Memos" - personal
information can be redacted
18. Please provide what "written information" was requested from the
Pathologist - Please provide the terms of service for the pathologist ie
what additional information are they providing to the CV-ISMB and the cost
associated.
8 March 2022 - Memo
4. Please provide the study used to evaluate the effect of the Pfizer
vaccine on thrombotic events
5. Coroner said death did not need to be investigated by them - please
provide the communications to the CV-ISMB from the coroner with
justification as to why coroner did not want to investigate
16. Again, benefits outweigh the risks - please provide the risk benefit
analysis that the CV-ISMB relied on
17. Please provide the study of thrombotic events as per section 17 - 20.
24. Please provide the minutes as Appendix 2.
8 March 2022 - Memo
Please link me to where all the CV-ISMB meeting minutes are at
18 March 2022 - Memo
9. Please provide Medsafes "regular" updates on Myocarditis, Pericarditis
in NZ - please provide all slides, data associated
10. Please provide all work associated with Post Partum congenital
abnormalities, documents associated / work completed by Medsafe?
Again - isn't this a bit late - pregnant woman are warned away from
mayonnaise yet they were recommended this gene therapy that the Ministry
of Health is still unable to produce or quantify any of the benefits
associated with this therapy.
Yours faithfully,
Chris
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From: Chris McCashin
Dear OIA Requests,
A follow up on this - please respond at the earliest convenience as this is now overdue
Yours sincerely,
Chris McCashin
From: OIA Requests
Kia ora Chris,
Thank you for your request for official information, received on 11 August
2022 requesting:
“MOH has recently dropped a number of Memo's completed by CV-ISMB on 2nd
August. I have reviewed the Memo's and I have the following queries,
follow ups.
7 May 2021 - Memo
This memo mentions there were three general meetings prior to this date
(last meeting 29 April) and an ad-hoc meeting (22 April) to look at
blood clotting/bleeding effects from some of the Covid-19 vaccines
reported overseas.
Ad hoc meeting to discuss thrombosis with thrombocytopenia (TTS).
Please provide all of the memo's prior to 7 May 2021 including all of
the ad-hoc meeting memos completed by the CV-ISMB.
The memo also notes "it would be beneficial to provide information on
this clotting/bleeding syndrome for the public, and in that case what
communication would be needed"
Please provide all of the ways, mediums, advertising, warnings from
vaccinators that were provided to the public notifying them of potential
clotting/bleeding? As at todays date, what has been provided to public
to warn them of this side effect?
The Memo Mentioned anaphylaxis is currently 8/260,000. Members
mentioned these numbers might end up being spuriously high and should be
assessed against Brighton Collaboration
Please provide total number of anaphylaxis cases following vaccination
in two data sets.
Total Anaphylaxis following vaccine
Total Anaphylaxis reported against Brighton Collaboration
Reporting against Brighton Collaboration will dilute the numbers will it
not? Why with a new treatment with no vaccine data would all of the
reports be recorded? Unless not to mislead the public?
At the time there were three potential safety signals under
investigation. This was May 2021 - why weren't people warned of these
"noted" safety signals - just because they weren't confirmed surely the
public have a right to know by vaccinator, informed consent that CV-ISMB
are already monitoring safety signals? Please note myocarditis numbers
using 2019 as a baseline show an over 900% increase based on recorded
AEFI's.
8 July 2021 - Memo - as alluded to above - PLEASE PROVIDE ALL MEMOS
Menstrual Irregularities - Given the menstruation cycle is directly
related to fertility surely this is a red flag and woman should have
been provided a warning about potential menstrual irregularities - what
monitoring, memos, warnings, addition to product label were added to
vaccine notifying people of potential menstrual irregularities?
This memo mentions Medsafe presented an update on Myocarditis - please
provide the minutes / memo associated with what Medsafe presented to
CV-ISMB - who, when, what was involved when Medsafe presented to CV-ISMB
associated with Myocarditis - please provide the slides from this
presentation.
This memo mentions all reports of death up until 24th June have been
presented to CV-ISMB with a number of deaths in the frail and elderly.
The CV-ISMB commented that there is a need to be careful attributing
death to "natural causes" in the frail elderly, as
they can pass away from mild external stress, such as vaccination.
This acknowledges a "causal" link between vaccination and death - it
mentions that vaccinating the elderly was due to be considered by the
Covid-19 Vaccine Technical Advisory was considering this - please
provide any and all information, memos, notes, studies that this group
looked at when considering whether or not to continue vaccinating the
elderly? I require the meeting notes and memo associated with this
meeting.
12 August 2021 - Memo
Please provide the "expert opinion" completed by Ralph Stewart
cardiologist
This memo mentions the benefits continue to outweigh the risks - please
provide the benefit / risk assessment that was used to support the
statement from the board?
17 September 2021 - MemoPlease provide the "expert opinion" completed by
Dr Laura Young
It appears the death was put down to another drug - again the benefits
continue to outweigh the risks - please provide an updated benefit /
risk assessment that supports the statement by the board?
4 October 2021 - Memo
This memo mentions under reporting - so the CV-ISMB knows that under
reporting relates to vaccine injuries - please provide what the CV-ISMB
has to support how under reported vaccine injuries are - what studies
show the rate of vaccine injury under reporting?
12. Please provide the communications that went out to Clinicians,
Cardiologists and Pathologists as per point 12 of this memo
11 October 2021 - Memo
10. Please provide the papers, memos, reporting completed by Medsafe /
CV-ISMB regarding Myocarditis and the publishable deliverables mentioned
by this Memo.
11. Vaccination in Pregnancy - Please provide all of the data
associated with pregancies, congenital abnormalities and the ongoing
work associated? Is it not a bit late to review abnormalities when they
could have been avoided without vaccine?
13 December 2021 - Memo4. Only 2 of 3 referred to Coroner - why was the
third case not referred to Coroner? Previous OIA requests say Medsafe /
Carm do not investigate deaths - this mentions the case was reported to
CARM - why not the Coroner?
9. Please provide the memo of the call with UK Medicines on Friday 9
December 2021 discussing fatal cases of myocarditis in UK? Surely people
dying globally requires the vaccine to be stopped? There was no doubt at
this stage that people are dying all over the world?
10. Please provide the update by Medsafe to the board including slides
of myocarditis in New Zealand.
The communication again mentions benefits outweigh the risks - please
provide the risk / benefit analysis that was used to support this
statement?
11. ii - Please provide any and all communications made to public,
vaccinators etc warning of Myocarditis - as at this date please confirm
verbal & written information vaccinators are required to convey to
someone receiving the vaccine to ensure they have informed consent?
Recent social media shows Pharmacists are not verbally warning of risks
12. Board did not raise benefit / risk balance, please provide the
benefit risk balance being relied on?
15. Please provide Appendix 1 of this memo
25 February 2022 - Memo
6. Please provide the interim report completed by the CV-ISMB with the
boards findings.
9. As alluded to above, not all memos have been provided - please
provide all of these
9. Eighteen safety signals have been considered with 28 Recommendations
- please provide all of the 28 Recommendations
9. Only one safety signal has been confirmed - this was added to the
product label - please provide exactly what was added to the product
label? Are the general public warned of what is on the product label?
Please provide the current product label
10. Please provide international and NZ data presented that the vaccine
is "very safe vaccine" as per this statement - any and all Post
Marketing studies
11. As alluded to above - please provide the interim report
25 February 2022 - Memo
5. Please provide the recommendation from the WHO for the appointment
of these people to the oversight committee? Why are the WHO providing
recommendations to NZ oversight committees?
6. Appears memos are missing from 26 January and 9 February - as
alluded to above I want all of the memos - please provide these
9. Please provide the memos presented to the board for booster doses
for 5 - 11 year olds?
17. Please provide all "Extraordinary Meeting Memos" - personal
information can be redacted
18. Please provide what "written information" was requested from the
Pathologist - Please provide the terms of service for the pathologist ie
what additional information are they providing to the CV-ISMB and the
cost associated.
8 March 2022 - Memo
4. Please provide the study used to evaluate the effect of the Pfizer
vaccine on thrombotic events
5. Coroner said death did not need to be investigated by them - please
provide the communications to the CV-ISMB from the coroner with
justification as to why coroner did not want to investigate
16. Again, benefits outweigh the risks - please provide the risk
benefit analysis that the CV-ISMB relied on
17. Please provide the study of thrombotic events as per section 17 -
20.
24. Please provide the minutes as Appendix 2.
8 March 2022 - Memo
Please link me to where all the CV-ISMB meeting minutes are at
18 March 2022 - Memo
9. Please provide Medsafes "regular" updates on Myocarditis,
Pericarditis in NZ - please provide all slides, data associated
10. Please provide all work associated with Post Partum congenital
abnormalities, documents associated / work completed by Medsafe?.”
The Ministry of Health has decided to extend the period of time available
to respond to your request under section 15A of the Official Information
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You can now expect a response to your request on, or before, 6 October
2022.
You have the right, under section 28 of the Act, to ask the Ombudsman to
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request.
Ngâ mihi
OIA Services Team
M[1]inistry of Health information releases
U[2]nite against COVID-19
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References
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hide quoted sections
From: OIA Requests
Kia ora Chris
Partial response to your request for official information
Thank you for your request under the Official Information Act 1982 (the
Act) on 11 August 2022. You stated:
MOH has recently dropped a number of Memo's completed by CV-ISMB on 2nd
August. I have reviewed the Memo's and I have the following queries,
follow ups.
A response to each part of your request is below:
7 May 2021 - Memo
This memo mentions there were three general meetings prior to this date
(last meeting 29 April) and an ad-hoc meeting (22 April) to look at blood
clotting/bleeding effects from some of the Covid-19 vaccines reported
overseas.
Ad hoc meeting to discuss thrombosis with thrombocytopenia (TTS).
Please provide all of the memo's prior to 7 May 2021 including all of the
ad-hoc meeting memos completed by the CV-ISMB.
The memo also notes "it would be beneficial to provide information on this
clotting/bleeding syndrome for the public, and in that case what
communication would be needed"
Please provide all of the ways, mediums, advertising, warnings from
vaccinators that were provided to the public notifying them of potential
clotting/bleeding? As at todays date, what has been provided to public to
warn them of this side effect?
There were no COVID-19 Vaccine Independent Safety Monitoring Board
(CV-ISMB) memorandums completed before 7 May 2021.
Please note, Thrombosis with Thrombocytopenia Syndrome (TTS) is not a side
effect of Comirnaty, but rather the Janssen and AstraZeneca COVID-19
vaccines.
There are various informative publications on the possible side effects of
COVID-19 vaccines. I have included examples below that you may be
interested in:
o [1]www.medsafe.govt.nz/Consumers/cmi/c/comirnaty.pdf
o [2]www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-side-effects-and-reactions
o [3]www.medsafe.govt.nz/Consumers/educational-material/Thrombosis-with-Thrombocytopenia-Syndrome.pdf
o [4]www.medsafe.govt.nz/safety/DHCPLetters/Distinguishing-between-Thrombosis-and-TTS.pdf
Medsafe issued a statement in April 2021 explaining that TTS was not
linked to the Comirnaty COVID-19 vaccine:
[5]www.medsafe.govt.nz/safety/Alerts/COVID-19-vaccine-blood-clots.asp.
The Memo Mentioned anaphylaxis is currently 8/260,000. Members mentioned
these numbers might end up being spuriously high and should be assessed
against Brighton Collaboration
Please provide total number of anaphylaxis cases following
vaccination in two data sets.
Total Anaphylaxis following vaccine
Total Anaphylaxis reported against Brighton Collaboration
Reporting against Brighton Collaboration will dilute the numbers will it
not? Why with a new treatment with no vaccine data would all of the
reports be recorded? Unless not to mislead the public?
The use of the Brighton criteria helps to correctly attribute whether a
reported case is anaphylaxis, for example, some cases of allergic reaction
and anxiety have been reported to the Centre for Adverse Reactions
Monitoring (CARM) as anaphylaxis.
Brighton criteria are recommended to be filled out when filling out
anaphylaxis report; Anaphylaxis reporting rates available at Medsafe
safety report website:
[6]www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp
At the time there were three potential safety signals under
investigation. This was May 2021 - why weren't people warned of these
"noted" safety signals - just because they weren't confirmed surely the
public have a right to know by vaccinator, informed consent that CV-ISMB
are already monitoring safety signals? Please note myocarditis numbers
using 2019 as a baseline show an over 900% increase based on recorded
AEFI's.
Information on safety signals can be found in the Medsafe safety report:
[7]www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp
8 July 2021 - Memo - as alluded to above - PLEASE PROVIDE ALL MEMOS
Menstrual Irregularities - Given the menstruation cycle is directly
related to fertility surely this is a red flag and woman should have been
provided a warning about potential menstrual irregularities - what
monitoring, memos, warnings, addition to product label were added to
vaccine notifying people of potential menstrual irregularities?
A safety communication was issued by Medsafe on 17 November 2021, titled
“Menstrual disorders and unexpected vaginal bleeding – Cominarty (Pfizer
COVID-19 Vaccine)”. This can be found here:
[8]www.medsafe.govt.nz/safety/SafetyCommunications.asp
This memo mentions Medsafe presented an update on Myocarditis - please
provide the minutes / memo associated with what Medsafe presented to
CV-ISMB - who, when, what was involved when Medsafe presented to CV-ISMB
associated with Myocarditis - please provide the slides from this
presentation.
The minutes of the CV-ISMB meetings are published on the Ministry website
here:
[9]www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-information-health-professionals/covid-19-vaccine-strategy-planning-insights/covid-19-who-were-working.
Please refer to the 24 June meeting notes.
This memo mentions all reports of death up until 24th June have been
presented to CV-ISMB with a number of deaths in the frail and elderly.
The CV-ISMB commented that there is a need to be careful attributing death
to "natural causes" in the frail elderly, as
they can pass away from mild external stress, such as vaccination.
This acknowledges a "causal" link between vaccination and death - it
mentions that vaccinating the elderly was due to be considered by the
Covid-19 Vaccine Technical Advisory was considering this - please provide
any and all information, memos, notes, studies that this group looked at
when considering whether or not to continue vaccinating the elderly? I
require the meeting notes and memo associated with this meeting.
This information can be found in a CV-TAG memo which can be found here:
[10]www.health.govt.nz/system/files/documents/pages/cv_tag_second_boosters_update.pdf
17 September 2021 - Memo
Please provide the "expert opinion" completed by Dr Laura Young
It appears the death was put down to another drug - again the benefits
continue to outweigh the risks - please provide an updated benefit / risk
assessment that supports the statement by the board?
This information can be found in CV-ISMB minutes which can be found here:
[11]www.health.govt.nz/system/files/documents/pages/h202200492-documents-redacted.pdf .
We note that throughout your request you have asked for benefit and risk
assessment supporting statements by the CV-ISMB. You can find information
around benefit and risk assessment here:
[12]www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Medsafe-Evaluation-Process.asp
The Board applies these principles when considering the safety data for
COVID-19 vaccines.
4 October 2021 - Memo
This memo mentions under reporting - so the CV-ISMB knows that under
reporting relates to vaccine injuries - please provide what the CV-ISMB
has to support how under reported vaccine injuries are - what studies show
the rate of vaccine injury under reporting?
This is addressed in the 15 September 2021 CV-ISMB minutes which can be
found here:
[13]www.health.govt.nz/system/files/documents/pages/h202200492-documents-redacted.pdf
11 October 2021 - Memo
Please provide the papers, memos, reporting completed by Medsafe / CV-ISMB
regarding Myocarditis and the publishable deliverables mentioned by this
Memo.
Information related to the ongoing follow-up study of reported cases of
myocarditis and pericarditis in New Zealand after the Pfizer COVID-19
vaccine is available here:
[14]www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-pfizer-vaccine-side-effects-and-reactions/covid-19-vaccine-myocarditis-and-pericarditis-study
13 December 2021 - Memo
Only 2 of 3 referred to Coroner - why was the third case not referred to
Coroner? Previous OIA requests say Medsafe / Carm do not investigate
deaths - this mentions the case was reported to CARM - why not the
Coroner?
The Ministry does not refer deaths to the coroner. Further information on
the Coroner can be found here:
[15]https://coronialservices.justice.govt.nz...
Please provide any and all communications made to public, vaccinators etc
warning of Myocarditis - as at this date please confirm verbal & written
information vaccinators are required to convey to someone receiving the
vaccine to ensure they have informed consent?
Recent social media shows Pharmacists are not verbally warning of risks
This information is publicly available at:
o [16]www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-information-health-professionals/covid-19-vaccine-operating-and-planning-guidelines
o [17]www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-resources
o [18]https://covid19.govt.nz/covid-19-vaccine...
o [19]https://covid.immune.org.nz/
15. Please provide Appendix 1 of this memo
Our decision regarding this Appendix was communicated to you in your
previous response H202207158. The appendix is withheld in full under
section 9(2)(ba)(ii) to protect information that is subject to an
obligation of confidence and making it available would likely damage the
public interest.
25 February 2022 - Memo
Please provide the interim report completed by the CV-ISMB with the boards
findings.
The interim report is publicly available here:
[20]www.health.govt.nz/system/files/documents/pages/cv-ismb-interim-report-updated-july-2022.pdf
As alluded to above, not all memos have been provided - please provide all
of these
All CV-ISMB memorandums have been released to you in your previous OIA
response H202207158.
Eighteen safety signals have been considered with 28 Recommendations -
please provide all of the 28 Recommendations
These are provided in the interim report which can be found here:
[21]www.health.govt.nz/system/files/documents/pages/cv-ismb-interim-report-updated-july-2022.pdf.
Only one safety signal has been confirmed - this was added to the product
label - please provide exactly what was added to the product label? Are
the general public warned of what is on the product label? Please provide
the current product label
This is available in the data sheet here:
[22]https://www.medsafe.govt.nz/profs/Datash...
In addition to the data sheet, which is available to the general public,
there is also a consumer medicine information sheet for Comirnaty:
[23]www.medsafe.govt.nz/Consumers/cmi/c/comirnaty.pdf.
Information regarding data sheets are available on the Medsafe website:
[24]www.medsafe.govt.nz/Medicines/infoSearch.asp.
Please provide international and NZ data presented that the vaccine is
"very safe vaccine" as per this statement - any and all Post Marketing
studies
As alluded to above - please provide the interim report
Please refer to the interim report:
[25]www.health.govt.nz/system/files/documents/pages/cv-ismb-interim-report-updated-july-2022.pdf.
25 February 2022 - Memo
Please provide the recommendation from the WHO for the appointment of
these people to the oversight committee? Why are the WHO providing
recommendations to NZ oversight committees?
Please see the World Health Organisation (WHO) COVID-19 Safety
Surveillance Manuel here:
[26]https://apps.who.int/iris/handle/10665/3...
Appears memos are missing from 26 January and 9 February - as alluded to
above I want all of the memos - please provide these
Please provide all "Extraordinary Meeting Memos" - personal information
can be redacted
All CV-ISMB memorandums have been released to you in your previous OIA
response H202207158.
The remaining parts of your request are quoted below, and will be
responded to in due course:
12 August 2021 – Memo
Please provide the "expert opinion" completed by Ralph Stewart
cardiologist
This memo mentions the benefits continue to outweigh the risks - please
provide the benefit / risk assessment that was used to support the
statement from the board?
Please provide the communications that went out to Clinicians,
Cardiologists and Pathologists as per point 12 of this memo
Vaccination in Pregnancy - Please provide all of the data associated with
pregancies, congenital abnormalities and the ongoing work associated? Is
it not a bit late to review abnormalities when they could have been
avoided without vaccine?
Please provide the memo of the call with UK Medicines on Friday 9 December
2021 discussing fatal cases of myocarditis in UK? Surely people dying
globally requires the vaccine to be stopped? There was no doubt at this
stage that people are dying all over the world?
Please provide the update by Medsafe to the board including slides of
myocarditis in New Zealand. The communication again mentions benefits
outweigh the risks - please provide the risk / benefit analysis that was
used to support this statement?
Board did not raise benefit / risk balance, please provide the benefit
risk balance being relied on?
Please provide the memos presented to the board for booster doses for 5 -
11 year olds?
Please provide what "written information" was requested from the
Pathologist - Please provide the terms of service for the pathologist ie
what additional information are they providing to the CV-ISMB and the cost
associated.
8 March 2022 - Memo
Please provide the study used to evaluate the effect of the Pfizer vaccine
on thrombotic events
Coroner said death did not need to be investigated by them - please
provide the communications to the CV-ISMB from the coroner with
justification as to why coroner did not want to investigate
Again, benefits outweigh the risks - please provide the risk benefit
analysis that the CV-ISMB relied on
Please provide the study of thrombotic events as per section 17 - 20.
Please provide the minutes as Appendix 2.
8 March 2022 – Memo
Please link me to where all the CV-ISMB meeting minutes are at
18 March 2022 - Memo
Please provide Medsafes "regular" updates on Myocarditis, Pericarditis in
NZ - please provide all slides, data associated
10. Please provide all work associated with Post Partum congenital
abnormalities, documents associated / work completed by Medsafe?
Again - isn't this a bit late - pregnant woman are warned away from
mayonnaise yet they were recommended this gene therapy that the Ministry
of Health is still unable to produce or quantify any of the benefits
associated with this therapy.
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: [27][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[28]inistry of Health information releases
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4. http://www.medsafe.govt.nz/safety/DHCPLe...
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6. http://www.medsafe.govt.nz/COVID-19/vacc...
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9. http://www.health.govt.nz/covid-19-novel...
10. http://www.health.govt.nz/system/files/d...
11. http://www.health.govt.nz/system/files/d...
12. http://www.medsafe.govt.nz/Consumers/Saf...
13. http://www.health.govt.nz/system/files/d...
14. https://www.health.govt.nz/covid-19-nove...
15. https://coronialservices.justice.govt.nz...
16. http://www.health.govt.nz/covid-19-novel...
17. http://www.health.govt.nz/covid-19-novel...
18. https://covid19.govt.nz/covid-19-vaccines/
19. https://covid.immune.org.nz/
20. http://www.health.govt.nz/system/files/d...
21. http://www.health.govt.nz/system/files/d...
22. https://www.medsafe.govt.nz/profs/Datash...
23. http://www.medsafe.govt.nz/Consumers/cmi...
24. http://www.medsafe.govt.nz/Medicines/inf...
25. http://www.health.govt.nz/system/files/d...
26. https://apps.who.int/iris/handle/10665/3...
27. mailto:[email address]
28. https://www.health.govt.nz/about-ministr...
29. https://covid19.govt.nz/
hide quoted sections
From: Chris McCashin
Dear OIA Requests,
Again this response seems to generate more questions than answers - for further follow ups
1. You state there were no Covid memorandums prior to 7 May 2021. So please provide me the scope of works with the CV-ISMB, how much they were paid by that date, deliverables associated with CV-ISMB - what did they do if they didn't produce one memo in the first five months of them being paid?
2. Medsafes own data confirms that TTS has occurred from the Pfizer vaccine - how can you say this isn't a side effect from the Pfizer vaccine when there are over 60 side effects registered on your own data that this is a side effect?
3. Thousands of dollars in compensation and treatment has been paid out by ACC for vaccine side effects. Please provide all of the side effects that ACC has paid out on - are there more side effects that ACC have been paid out on listed as possible side effects
4. The statement was issued yet since that date TTS has been registered with CARM - if our own data registers TTS as a side effect why won't you acknowledge this - has ACC paid out any compensation for TTS?
5. Please provide data as requested on the anaphalaxis - how many cases of anaphalaxis were not recorded when measuring against the Brighton Collaboration
6. Were people prior to vaccination warned of all the safety signals?
7. A safety communication was issued - are these safety communications relayed to people prior to vaccination? If not, why not?
8. This memo mentions the benefits clearly outweigh the risks - what documents, evidence were relied on that the benefits of a vaccine that does not stop you getting or transmitting a virus with a 99% recovery rate outweigh the risks for a heart condition that can ruin ones life (and has done including death in NZ)
9. Please provide all the benefit / risk assessments based on the ever evolving data. Please provide all of the documents used to assess efficacy, if it is better than a placebo (comparison against placebo groups), alternative treatments considered, number of people with condition, history of disease
The link you sent me through outlines the criteria when considering the benefits risks - please provide all of the reports purporting this information and provide to me
10. I have read the minutes you don't need to link me through to stuff you have sent - what is the average "under reporting" rate of vaccine injuries for this medication and previous medications
11. This means nothing - you are studying people after you have injured them - a 400% increase in Myocarditis and likely numerous delayed deaths through cardiac arythmia in children is going to occur going forward in New Zealand and is already happening overseas
12. Whilst the information is publically available are vaccinators warning of Myocarditis so that New Zealanders get informed consent?
13. Please provide appendix one
14. I have read the safety signals - however are people warned of the safety signals per informed consent process
15. The datasheet is not available - please provide links that work
I trust Ministry of Health have seen Pfizer executives are now testifying under oath that the vaccine was never tested regarding transmitting the virus
Please provide all of the information / studies that Ministry of Health relied on to say the vaccine would stop transmission which was part of the original messaging
Thanks
Yours sincerely,
Chris McCashin
From: OIA Requests
Kia ora Chris,
Thank you for your follow up request for official information. The
reference number for your request is: H2022014805.
As required under the Official Information Act 1982, Manatū Hauora 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/
If you have any queries related to this request, please do not hesitate to
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From: OIA Requests
Kia ora Chris
Please find attached a response to your request for official information.
Ngā mihi
OIA Services Team
Manatū Hauora | Ministry of Health
M[1]inistry of Health information releases
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From: Government Services
Kia ora Chris
Please find attached our response to your official information request
dated . If you have any questions about the response you can contact us at
this [1]address, for all other matters please use our contact form
at: [2]https://www.acc.co.nz/contact/ alternatively give us a call on 0800
101 996.
If you are having trouble viewing the PDF, please ensure you have the
latest version of Adobe Acrobat Reader. To download this freeware please
click [3]here.
Ngâ mihi
Sara Freitag (she/her)
Acting Manager | OIA Services
' 027 973 7330
* PO Box 242, Wellington 6011
ACC cares about the environment – please don’t print this email unless it
is really necessary. Thank you.
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Tçnâ koe Chris
Please see the attached response to your request for official information.
Ngâ mihi
Ministerial Services
Government Partnership and Risk
Email: [1][email address]
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From: Chris McCashin
Dear hnzOIA,
Complaint to Ombudsman
Please provide information in full and documents not blacked out
Given this so called treatment was forced on New Zealanders the data is not looking good
It also appears you are taking off cases of myocarditis?
“CARM removed 38 cases”
All of the information provided points to serious issues with this treatment and CARM, CV-ISMB, CV-TAG all trying to water down death and serious injury from this poison. The complaint is going to Ombudsman and further follow ups are required.
One case of mercury poisoning from a beauty product and the stock is seized and, tested and investigated. Deaths and serious injury from this poison and we have three expert groups all trying to dismiss, water down, hide, obfuscate, manipulate data, dismiss consideration and fob people off?!
This is a crime. Stop trying to cover things up - admit what has gone on and let’s work out how who needs to be held accountable for all of these suspect deaths.
Yours sincerely,
Chris McCashin
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