133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
3 December 2021
Athina Andonatou
By email: [FYI request #17529 email]
Ref: H202115966
Dear Athina
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health (the Ministry) on 15 November 2021. Please find a response to each part of your request
below.
Given that the COVID-19 Independent Safety Monitoring Board are the ones responsible
for determining whether deaths that occurred after receiving the comirnaty injection are
attributed to the vaccine, independence is crucial. Yet how independent can they be when
their wages are being paid by the government? Does that not create a conflict of interest?
Just like a tobacco company funding the research that says smoking was not a cause for
cancer, we now know different.
Please note the cause of death is investigated and determined by Coroners, an independent
judicial officer, and not the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB).
For further information about the coronial process please see here:
https://coronialservices.justice.govt.nz/coronial-services/.
The CV-ISMB have declared their conflicts of interest. They are paid for their time however they
have other employment and are not dependant on the ISMB remuneration.
Given the 94 deaths registered with CARM as of 23 Oct 2021 it is of grave concern that
only one of the deaths is being attributed to the injection being unrolled.
1) I'd like any correspondence the COVID-19 Independent Safety Monitoring Board have
used to assess whether the death or adverse effect was related the receiving of the
injection, without any identifying information of the person that correspondence relates to.
This part of your request is withheld under section 9(2)(a) of the Act to protect the privacy
of natural persons, including deceased natural persons.
2) Correspondence on how it was determined that 42 deaths could not be assessed due to
insufficient information, without any identifying information of the person that
correspondence relates to.
As there was no information to assess, the Ministry cannot provide you with the requested
correspondence.
3) Correspondence relating to the 10 cases that are still under investigation, without any
identifying information of the person that correspondence relates too.
As mentioned above, the coroner investigates and determines cause of death, as such the
Ministry does not hold correspondence relating to this part of your request.
4) Please provide me with the protocol the COVID-19 Independent Safety Monitoring Board
use when determining cause of the deaths reported in the CARM register
Please find attached to this letter a diagram for the process for assessment of reports of death
from COVID-19 to the Centre for Adverse Reactions Monitoring (CARM) at the New Zealand
Pharmacovigilance Centre. CARM undertakes pharmacovigilance under contract to the Ministry.
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:
[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:
www.health.govt.nz/about-ministry/information-releases. Yours sincerely
Chris James
Group Manager
Medsafe
Page 2 of 2
Process for Assessment of Report of Death
Centre for Adverse Reactions Monitoring (CARM) and the COVID-19 Vaccination and
Immunisation Programme (CVIP) agree that this is the process that all deaths
reported to CARM for the COVID-19 vaccines must undergo for adequate
assessment into a potential causal relationship of death1 and associated adverse
events to COVID-19 vaccination event.
Report of death following vaccination
Member of public reports
Medical practicioner
Act 1982
reports
Verify vaccination event against CIR
INFORMATION
Contact reporter for
Contact medical practitioner
contact details of GP (2
(2 attempts minimum)
attempts minimum)
Is the death unexpected/unexplained?
Can’t verify
address
With coroner?
Case not referred to
No NHI match
the Coroner
Failed follow up
with reporter
Ministry will obtain
Death
Hospital
the preliminary
register
notes
post-mortem OR
pathway
follow up
any other post-
mortem
RELEASED UNDER THE OFFICIAL
investigation as
Report
needed
unvalidated.
ISMB for input
1 A death is an outcome and
not an adverse reaction
Close case.
