Chris McCashin
[FYI request #20204 email]
Tēnā koe Chris,
Your Official Information Act request, reference H2022010003:
Thank you for your email of 11 August 2022 requesting information relating to COVID 19 Vaccine
Independent Safety Monitoring Board (CV-ISMB) memos. 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 fol owing queries, fol ow ups.
On 6 October 2022 Te Whatu Ora (Health New Zealand) partial y responded to your request. The
remaining parts of your response are quoted and responded to below:
12 August 2021 - Memo
Please provide the "expert opinion" completed by Ralph Stewart cardiologist
Professor Ralph Stewart verbally provided his opinion to the Board, rather than in the form of a memo. An
abbreviation of this can be found in the minutes of the meeting, which has been provided to you as
Document 2 attached to this letter.
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?
As explained in the first release of information to you, the Board applies these principles when considering
the safety data for COVID-19 vaccines:
www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Medsafe-Evaluation-Process.asp
There is no specific document outlining benefit/risk assessment. The principles are embedded throughout
the Board’s analysis, which is captured both within the memo and the minutes of the meeting and have
been provided to you as Document 2.
4 October 2021 - Memo
Please provide the communications that went out to Clinicians, Cardiologists and Pathologists as
per point 12 of this memo
Two letters have been identified in scope of this part of your request. These are itemised in Appendix 1 and
copies of the documents are enclosed. These are being released to you in ful .
11 October 2021 - Memo
Vaccination in Pregnancy - Please provide all of the data associated with pregnancies, congenital
abnormalities and the ongoing work associated? Is it not a bit late to review abnormalities when
they could have been avoided without vaccine?
Two documents have been identified as being within the scope of this part of your request. These are
itemised in Appendix 1 and copies of the documents are enclosed. Where information is withheld under
section 9 of the Act, I have considered the countervailing public interest in release in making this decision
and consider that it does not outweigh the need to withhold at this time.
Medsafe has also published the following communication regarding vaccination in pregnancy:
www.medsafe.govt.nz/safety/Alerts/covid-19-vaccination-in-pregnancy.asp.
13 December 2021 - Memo
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?
This information is being withheld in ful under section 6(b)(i) of the Act, as its release would prejudice
information entrusted to the Government of New Zealand from another Government or agency.
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?
This information can be found in the CV-ISMB minutes which have been provided to you as
Document 8. Please see the comments above regarding benefit and risk analysis.
25 February 2022 - Memo
Please provide the memos presented to the board for booster doses for 5 - 11 year olds?
Children aged 5 to 11 are not eligible to receive a booster dose of Comirnaty. As such, there are no
memorandums related to this. Therefore, this part of your request is refused under section 18(e) of the Act
as the information requested does not exist.
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.
This part of your request has been refused under section 18(e) of the Act, as the information requested
does not exist. No written information has been requested from the pathologist.
8 March 2022 - Memo
Please provide the study used to evaluate the effect of the Pfizer vaccine on thrombotic events
Information in response to this part of your request has been withheld under section 9(2)(f)(iv) of the Act to
maintain the constitutional conventions that protect the confidentiality of advice tendered by Ministers
and officials.
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
This part of your request has been withheld under section 9(2)(ba)(i) of the Act to protect information that
is subject to an obligation of confidence and making it available would likely prejudice the supply of similar
information, or information from the same source.
Again, benefits outweigh the risks - please provide the risk benefit analysis that the CV-ISMB relied
on
As signalled above, the Board applies these principles when evaluating the safety data of COVID-19
vaccinations, which is embedded throughout the minutes of each meeting:
www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Medsafe-Evaluation-Process.asp
The minutes from this meeting have been provided to you as Document 11.
Please provide the study of thrombotic events as per section 17 - 20.
This part of your request has been withheld under section 9(2)(f)(iv) of the Act to maintain the
constitutional conventions that protect the confidentiality of advice tendered by Ministers and
officials.
Please provide the minutes as Appendix 2.
The minutes from this meeting have been provided to you as Document 11.
Please link me to where all the CV-ISMB meeting minutes are at
The CV-ISMB minutes that have been made publicly available can be found here:
www.health.govt.nz/system/files/documents/pages/h202200492-documents-redacted.pdf.
18 March 2022 - Memo
Please provide Medsafes "regular" updates on Myocarditis, Pericarditis in NZ - please provide
all slides, data associated
Manatū Hauora has identified 6 documents within the scope of this part of your request. These are
itemised in Appendix 1 and copies of the documents are enclosed.
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 stil unable to produce or quantify
any of the benefits associated with this therapy.
The information you have requested can be found in Documents 5 and 12 which have been provided
to you.
I trust the information provided is of assistance. You are advised of your right to also raise any
concerns with the Office of the Ombudsman. Information about how to do this is available at:
www.ombudsman.parliament.nz or by phoning 0800 802 602.
Nāku iti noa, nā
Rachel Mackay
Acting Interim Director, Prevention
National Public Health Service
Te Whatu Ora - Health New Zealand
TeWhatuOra.govt.nz
PO Box 793
Wel ington 6140
Appendix 1: List of documents for release
#
Date
Document details
Decision on release
1
July 2021
Presentation – Overview of Comirnaty Some information withheld
under the fol owing sections of
the Act:
• Section 9(2)(a) to protect
the privacy of natural
persons; and
• Section 9(2)(g)(ii) to
protect Ministers,
members of
organisations, officers,
and employees from
improper pressure or
harassment.
2
9 August 2021
CV-ISMB Minutes
Some information withheld
under the fol owing sections of
the Act:
• 9(2)(a);
• 9(2)(g)(ii);
• 9(2)(g)(i) to maintain the
effective conduct of
public affairs through the
free and frank expression
of opinions by or
between or to Ministers
and officers and
employees of any public
service agency; and
• 18(c)(ii) as releasing the
information would
constitute a contempt of
court.
3
August 2021
Presentation - Comirnaty and
Some information withheld
myo/pericarditis
under the fol owing sections of
the Act:
4
9 September 2021
Presentation – Comirnaty and
•
myo/pericarditis
Section 9(2)(a); and
• Section 9(2)(g)(ii)
5
22 October 2021
Memo – Pregnancy-related AEFI reports Some information withheld
in New Zealand following
under the fol owing sections of
administration of Comirnaty
the Act:
• Section 9(2)(a);
• Section 9(2)(b)(ii) where
its release would likely
unreasonably prejudice
the commercial position
of the person who
supplied the information;
and
• Section 9(2)(g)(ii)
#
Date
Document details
Decision on release
6
27 October 2021
Presentation – Updated case reports
Some information withheld
myocarditis/pericarditis/myopericarditis under the fol owing sections of
the Act:
• Section 9(2)(a); and
• Section 9(2)(g)(ii)
7
December 2021
Presentation – Myo(peri)carditis
Some information withheld
overview.
under the following sections of
the Act:
• Section 9(2)(a);
• Section 9(2)(ba)(i) to
protect information that
is subject to an obligation
of confidence and
making it available would
likely prejudice the
supply of similar
information, or
information from the
same source; and
• Section 9(2)(g)(ii)
8
8 December 2021
CV-ISMB Minutes
Some information withheld
under the fol owing sections of
the Act:
• Section 9(2)(a);
• Section 9(2)(g)(i);
• Section 9(2)(g)(ii); and
• Section 18(c)(ii)
9
14 January 2022
Letter for pathologists
Released in full.
10
9 February 2022
Presentation – Update on reported
Some information withheld
cases of
under section 9(2)(g)(ii) of the
myocarditis/pericarditis/myopericarditis Act.
11
2 March 2022
CV-ISMB Minutes
Some information withheld
under the fol owing sections of
the Act:
• Section 9(2)(g)(ii); and
• Section 18(c)(ii).
12
23 March 2022
Memo – The safety of COVID-19
Some information withheld
vaccination during pregnancy
under the fol owing sections of
the Act:
• Section 9(2)(a);
• Section 9(2)(g)(ii);
• 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.
#
Date
Document details
Decision on release
13
28 February 2022
Letter for coronial investigation
Released in full.
14
September 2022
Presentation – Comirnaty and
mechanisms for adverse reactions
