133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
27 July 2023
Chris McCashin
By email: [FYI request #23525 email]
Ref:
H2023029281
Tēnā koe Chris,
Response to your request for official information Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Haoura
(the Ministry of Health) on 18 July 2023. Each part of your request is responded to below:
I note that the Covid-19 Vaccine Safety reports ended on 30 November 2022. Are you able
to direct me to the reports for 2023 and / or where I find that data
Medsafe will continue to publish safety information for COVID-19 vaccines on our website in line
with the information published for all other medicines and vaccines approved for use in New
Zealand. However, this will no longer be in the previous format of safety reports for COVID-19
Vaccines. Therefore, your request for the 2023 safety reports is refused under
section 18(g)(i) of the Act as the information is not held by Manatū Hauora or any other agency
subject to the Act.
Due to the reduced number of COVID-19 vaccines being administered and therefore reduced
numbers of adverse events following immunisation (AEFI) being reported, AEFI data from 30
November 2022 that would have previously been published in the COVID-19 safety reports is
currently withheld under the following grounds of the Act:
•
Section 9(2)(a) to protect the privacy of natural persons;
•
Section 9(2)(ba) protect information which is subject to an obligation of confidence,
where the making available of the information— would be likely to prejudice the supply
of similar information, and it is in the public interest that such information should
continue to be supplied; and
•
Section 9(2)(c) to avoid prejudice to measures protecting the health or safety of
members of the public.
Where information is withheld under section 9 of the Act I have considered the countervailing
public interest in releasing information and consider that it does not outweigh the need to withhold
at this time.
The final report dated 30 November 2022 noted that there were 184 deaths reported to
CARM. Are you able to provide for all of those 184 deaths.
As noted in the safety report, by chance, some people will experience new illnesses or die from a
pre-existing condition shortly after vaccination, especially if they are elderly. Out of these 184
deaths, medical assessments by CARM and Medsafe determined at the time of the report’s
release that:
•
163 of these deaths are unlikely related to the COVID-19 vaccine
•
15 deaths could not be assessed due to insufficient information
•
2 cases were still under investigation
•
2 deaths were determined by the Coroner to be due to myocarditis following first dose
Covid-19 (Pfizer) vaccination
•
1 death was likely due to vaccine induced myocarditis (awaiting Coroner’s
determination)
•
for 1 death a link to the vaccine could not be excluded, myocarditis was found at the
time of death (awaiting Coroner’s determination).
More information on how Medsafe conducts its review processes is publicly available here:
www.medsafe.govt.nz/COVID-19/safety-report-46.asp. I trust the above response fulfils this part of your request. However, please note if you were
seeking copies of individual AEFI reports, this information would be withheld to protect the
privacy of natural persons.
If you wish to discuss any aspect of your request with us, including this decision, please feel free
to contact the OIA Services Team on: [email address].
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
Manatū Hauora website at:
www.health.govt.nz/about-ministry/information-releases/responses-
official-information-act-requests. Nāku noa, nā
Derek Fitzgerald
Acting Group Manager
Medsafe
Page 2 of 2