Dear Ministry of Health,

Under the Official 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 submitted 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 attributed 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 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 willing to refine the scope if needed to facilitate timely processing.
Yours faithfully,

SPENCER JONES

Dear OIA Requests,

📝 Public Response to Ministry of Health (FYI.org.nz — OIA H2025067986)

Kia ora Ministry of Health,

I acknowledge receipt of your 4 June 2025 letter regarding my Official Information Act request (Ref: H2025067986), which seeks data and documentation related to myocarditis cases, COVID-19 vaccine safety processes, Medsafe’s pharmacovigilance methods, and transparency in prior OIA responses.

However, I must formally express concern that your current response fails to substantively engage with the content of the request, instead relying on a procedural acknowledgment and a vague notice of partial transfer to Health New Zealand (Te Whatu Ora) — without confirming what data has been transferred or why.

⸻

⚠️ Summary of Procedural and Substantive Concerns:

1. No Acknowledgement of Key Issues or Prior OIA Failures

Despite explicit references to earlier OIA responses (e.g. H202201773, H202117908), you have not confirmed:
• Whether the Ministry or Te Whatu Ora now holds the missing vaccination status for 132 myocarditis cases from 2021–2022;
• Whether causality attribution data (COVID-19 infection vs vaccination) for the 405 myocarditis cases exists and can be released;
• Whether annual myocarditis totals from 2020 to 2024 are available.

This silence is particularly troubling given the sharp increase in myocarditis cases and public interest in safety transparency.

2. No Engagement with Medsafe or Pfizer Safety Evaluation Questions

You have not stated:
• Whether Medsafe reviewed Pfizer’s 5.3.6 Cumulative Analysis of Post-Authorization Adverse Events Reports prior to vaccine approval;
• Whether statistical signal detection tools such as Empirical Bayesian methods or Proportional Reporting Ratios were used to evaluate myocarditis reports;
• Whether any safety signal reviews were conducted by CVTAG or CV-ISMB since 2022, particularly regarding myocarditis or menstrual irregularities.

These are not complex or high-burden questions — they are binary yes/no issues with profound public interest implications.

3. Lack of Transparency on Partial Transfer

You mention that parts of the request have been transferred to Health New Zealand, but fail to:
• Identify which sections were transferred;
• Confirm the date of transfer and the point of contact at Te Whatu Ora;
• Clarify which agency (MoH or Te Whatu Ora) retains responsibility for coordination and final response.

Without this information, your actions risk fragmenting accountability, delaying scrutiny, and confusing the requester’s right of access under the Act.

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🧾 Next Steps Sought (Prior to Ombudsman Referral)

To resolve this efficiently, I now respectfully request the following by no later than 2 July 2025:
1. Confirmation of whether the following data is held, and by whom:
• Vaccination status breakdown of the 405 myocarditis cases in 2021–2022 (as per H202201773);
• Attribution analysis (infection vs vaccination) of said cases;
• Aggregated annual myocarditis case numbers from 2020–2024;
• All internal Medsafe or CVTAG documents relating to myocarditis, menstrual cycle disruption, or vaccine risk-benefit assessment updates;
• Whether Pfizer’s 5.3.6 safety report was reviewed, and what other post-marketing surveillance documents were assessed.
2. Clarification of transfer details:
• Which sections of the request were transferred to Health New Zealand;
• On what date the transfer occurred;
• When a response from Te Whatu Ora can reasonably be expected.
3. Notice of any anticipated use of section 9 exemptions:
• If you intend to withhold any data under ss 9(2)(a), (b), (ba), or (f), please indicate this now with reference to your obligations under s 10 (refusal to confirm or deny) and s 19(a)(ii) (requirement to state grounds for withholding).

⸻

📣 Public Interest Justification

This request directly concerns public health policy, the transparency of pharmacovigilance processes, and the accuracy of safety information provided to New Zealanders during the COVID-19 vaccination campaign. Delays, generalities, or administrative fragmentation erode public confidence — particularly when myocarditis remains a known risk of mRNA vaccination, acknowledged by Medsafe, CDC, EMA, and others.

⸻

⚖️ Notice of Intended Complaint

If a complete, clear, and good faith response is not received by 2 July 2025, I will be lodging a formal complaint with the Office of the Ombudsman. Grounds will include:
• Failure to confirm whether known data is held;
• Failure to identify which information has been transferred and by what statutory authority;
• Failure to engage with known data gaps from prior OIA requests;
• Evasion of transparency duties on matters of critical public interest.

Kind regard’s
Spencer Jones