133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
17 June 2025
Spencer Jones
By email: [FYI request #31200 email]
Ref:
H2025067986
Tēnā koe Spencer
Partial transfer of your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health - Manatū Hauora (the Ministry) on 3 June 2025. A full copy of your request is amended
to this letter.
Information relating to the following part of your request is held by Health New Zealand – Te
Whatu Ora:
5. CVTAG and CV-ISMB Discussions
• Minutes, reports, or correspondence from CVTAG and the COVID-19 Vaccine
Independent Safety Monitoring Board (CV-ISMB) discussing myocarditis risks from 2020
to 2024, beyond those provided in OIA H202115672.
• Data or studies relied upon by CV-ISMB to conclude no link between menstrual
disorders and Comirnaty in 2021 (OIA H202218890), and any reassessments following
the U.S. NIH study (published 2022) confirming a link.
For this reason, the Ministry is transferring this part of your request to their agency under
section 14(b)(i) of the Act. You can expect a response from Health New Zealand in due course:
[email address]
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.
Nāku noa, na
Jan Torres
Manager, OIA Services
Government and Executive Services | Te Pou Whakatere Kāwanatanga
COPY OF OIA REQUEST
From: SPENCER JONES <[FYI request #31200 email]>
Sent on: Tuesday, June 3, 2025 6:28:16 AM
To: OIA/LGOIMA requests at Ministry of Health <[Ministry of Health request email]>
Subject: Official Information request - COVID-19 Vaccine Safety, Myocarditis, and
Transparency
Dear Ministry of Health,
Under the Of icial Information Act 1982, I request the following information held by the Ministry
of Health (MoH), Medsafe, or Health New Zealand (Te Whatu Ora) regarding COVID-19 vaccine
safety, myocarditis cases, and transparency processes. To facilitate a timely response, I have
prioritised specific data and documents relevant to public interest in vaccine safety.
This request is submit ed following a comprehensive review of prior OIA responses on
FYI.org.nz regarding COVID-19 vaccine safety, myocarditis reporting, and Medsafe
transparency. It is structured to address public concerns about delayed disclosures and missing
case breakdowns, and seeks specific documents referenced in earlier replies.
The request is supported by ongoing public interest and is intended to ensure accountable,
science-based policy transparency for the New Zealand public.
1. Myocarditis Case Data (2020–2024)
• Total number of myocarditis cases reported in New Zealand annually from 2020 to 2024, as
recorded in Medsafe’s Adverse Events Following Immunization (AEFI) system or other
databases (e.g., National Minimum Dataset).
• For 2021–2022, a detailed breakdown of the 405 myocarditis cases reported in Medsafe’s
AEFI reports (OIA H202201773), including:
• • Number of cases at ributed to COVID-19 infection vs. COVID-19 vaccination.
• • Vaccination status of each case (e.g., Pfizer/Comirnaty, other vaccines, unvaccinated, or
unknown).
• • Age and gender demographics of cases.
• For cases not attributed to vaccination, the methodology or criteria used to determine causality
(e.g., diagnostic tests, temporal association).
2. Vaccine Safety Monitoring Processes
• A description of Medsafe’s statistical methods for analyzing adverse event reports, including
whether Empirical Bayesian (EB) data mining, Proportional Reporting Ratio (PRR), or other
quantitative methods are used, as compared to U.S. CDC/FDA practices.
• Copies of any EB, PRR, or equivalent statistical analyses of COVID-19 vaccine adverse
events (redacted for proprietary information if necessary) conducted from 2020 to 2024.
• A list of international studies or data sources (e.g., U.S. VAERS, WHO VigiBase) relied upon
by Medsafe or the COVID-19 Vaccine Technical Advisory Group (CVTAG) to assess
myocarditis risks, with specific report titles or links where available.
3. Pfizer Safety Data
• Confirmation of whether Medsafe reviewed Pfizer’s “5.3.6 Cumulative Analysis of Post-
Authorization Adverse Event Reports” (through February 28, 2021) prior to approving the Pfizer-
BioNTech vaccine.
• A list of key safety reports or evidence provided by Pfizer to Medsafe for provisional and
extended approvals (2021–2023), as referenced in OIA H202117908, including document titles
and dates (redacted summaries if full disclosure is restricted).
• Details of any requests made by Medsafe to Pfizer for real-time safety data updates post-
global rollout (December 2020–December 2021).
4. Transparency and OIA Handling
• Copies of MoH or Medsafe guidelines for handling OIA requests related to COVID-19 vaccine
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safety, specifically criteria for applying Section 9(2) exemptions (e.g., commercial sensitivity,
privacy).
• Total number of OIA requests related to COVID-19 vaccine safety received from 2020 to 2024,
with a breakdown by outcome (e.g., fully granted, partially granted, refused, delayed beyond 20
working days).
• Explanation of why specific myocarditis data (e.g., vaccination status for 132 cases in OIA
H202201773) was not provided in prior responses, and confirmation of whether such data is
now available.
5. CVTAG and CV-ISMB Discussions
• Minutes, reports, or correspondence from CVTAG and the COVID-19 Vaccine Independent
Safety Monitoring Board (CV-ISMB) discussing myocarditis risks from 2020 to 2024, beyond
those provided in OIA H202115672.
• Data or studies relied upon by CV-ISMB to conclude no link between menstrual disorders and
Comirnaty in 2021 (OIA H202218890), and any reassessments following the U.S. NIH study
(published 2022) confirming a link.
Additional Notes
• If information is withheld under OIA exemptions, please provide the specific section,
justification, and a summary of withheld documents (e.g., titles, dates, page counts) to ensure
transparency.
• If data is unavailable, please clarify whether it was not collected, is incomplete, or is held by
another entity (e.g., Health NZ), and indicate where such data might be accessed.
• Please provide electronic copies of documents or links to publicly available sources where
applicable.
• For clarification, I can be contacted via fyi.org.nz’s messaging system, maintaining anonymity
as a public requester.
Given the public interest in vaccine safety transparency, I request a response within the
statutory 20 working days. I understand the MoH may face high request volumes and am wil ing
to refine the scope if needed to facilitate timely processing.
Yours faithfully,
SPENCER JONES
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