133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
9 August 2022
Chris McCashin
By email: [FYI request #18841 email]
Ref:
H2022005652
Dear Chris
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Hauora
(Ministry of Health) on 27 June 2022 as a follow up to information you received under reference:
H202205723. Specifically, you requested:
“Is the below excerpt from the Medsafe reports "misinformation"?
Is this Pfizer report "misinformation"?
https://scanmail.trustwave.com/?c=15517&d=wfe44rQgIGnbDd6Tna0zRhPfs6O6SZqkTk7z
r1EFlg&u=https%3a%2f%2fphmpt%2eorg%2fwp-
content%2fuploads%2f2021%2f11%2f5%2e3%2e6-postmarketing-experience%2epdf.
Summary of reported deaths
Up to and including 30 April 2022, a total of 160 deaths were reported to CARM after the
administration of the Comirnaty vaccine. Following medical assessments by CARM and
Medsafe it has been determined that:
99 of these deaths are unlikely related to the COVID-19 vaccine
48 deaths could not be assessed due to insufficient information
10 cases are still under investigation.
3 deaths were likely due to vaccine induced myocarditis (awaiting Coroner’s determination)
The above also states that there were 48 deaths that could not be assessed due to
insufficient information. Are you able to provide how these deaths are recorded? Please
provide the policy documents associated with recording deaths that could not be assessed
due to insufficient information.
How are these deaths categorised?
Cause of death unknown?
Unexplained?
Sudden Adult Death Syndrome?
What dataset will they be categorised in?
Depending on what dataset they are categorised in are you able to provide that dataset
from 2000-2022”
The link you attached to your request refers to the publication of a report, Cumulative Analysis
of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through
28-Feb-2021, in the United States. Manatū Hauora received several requests about this
document and has published a comprehensive response that explains its genesis and relevance
to New Zealand. It is publicly available at: www.health.govt.nz/system/files/documents/
information-
release/h202117570_response_0.pdf.
The Centre for Adverse Reactions Monitoring (CARM) and Medsafe investigate reports of
significant events, including those with a fatal outcome. In the first stage of the process, the report
is verified to check that there is an identifiable individual who has had a COVID-19 vaccination
and the reporter can be contacted. Any report that doesn’t meet these criteria is invalid and is not
further investigated. Sometimes the initial report doesn’t contain enough information for
assessment so CARM or Medsafe will seek further information from the reporter. For any report,
the reporter may be the person who experienced the event, their friend or relative, or the general
practitioner (GP) or other healthcare professional who treated them. Regardless of who reported
the significant event, the relevant healthcare professionals will be contacted for more information.
If the person died and their GP or doctor reported the death to the coroner, CARM will also
contact the coroner or the pathologist.
The investigation process can take some time and may not always be successful if there is no
response to requests for information or there is no further information to share. This results in a
death being categorised as
could not be assessed due to insufficient information.
Please note, that the cause of death is investigated and determined by the coroner, not by CARM
or Medsafe.
There are no Manatū Hauora or Medsafe ‘policy documents’ associated with recording deaths
that could not be assessed due to insufficient information. Therefore, this part of your request is
refused under section 18(e) of the Act as the document requested does not exist. However,
information about the follow up process for reports of adverse events with the COVID-19
vaccines, including fatal reports is publicly available on the Medsafe website here:
www.medsafe.govt.nz/COVID-19/q-and-a-vaccine-safety.asp.
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 Manatu
Hauorā website at: www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests.
Yours Sincerely
Chris James
Group Manager
Medsafe
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