This request was submitted in response to multiple credible media reports (Stuff NZ, NZ Herald, STAT News) from 29–30 November 2025, referencing an internal U.S. FDA memo linking at least 10 child deaths to COVID-19 mRNA vaccines.

The article quotes FDA sources acknowledging that fatalities occurred in close temporal proximity to vaccination in children, and that current surveillance systems may lack sufficient granularity to definitively rule out vaccine-related causality in rare or catastrophic outcomes.

Given the continued inclusion of mRNA COVID-19 vaccines in New Zealand’s childhood immunisation schedule and the recent extension of Medsafe’s provisional approval for Comirnaty, this OIA seeks to determine whether:
• Medsafe or the Ministry of Health has reviewed this new U.S. information;
• Any internal risk assessments or policy adjustments have occurred as a result;
• Any communications with the FDA, WHO, CV-ISMB, or Pfizer have addressed these concerns;
• There are gaps in pharmacovigilance or adverse event detection that could be mitigated in New Zealand.

This request is made in the public interest, especially in light of previous OIA refusals under sections 18(e) and 9(2)(g)(i), which have shielded safety review details from public scrutiny.

A follow-up request will be filed if this is declined or partially withheld.

Public Annotation – Context & Significance of This Refusal

Request: Impact of U.S. FDA memo on COVID-19 vaccine safety monitoring

Status: Refused (s18(g)) – 16 December 2025
Requester: Spencer Jones

This Official Information Act request sought confirmation of whether the Ministry of Health or Medsafe had undertaken any internal consideration, assessment, or correspondence in response to widely reported claims attributed to a U.S. FDA internal memo concerning paediatric COVID-19 vaccine safety (reported late November 2025).

The Ministry has refused the request in full under section 18(g)(i), stating that:
• no relevant information is held, and
• there are no grounds to believe it is held by another agency subject to the Act.

The response also states that the Ministry “has not and does not intend to review COVID-19 vaccines or the programme based on media stories.”

No documents were released, and no partial confirmation was provided.

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Why this response matters

This refusal is not notable because of the subject matter alone, but because it reflects a recurring transparency pattern visible across multiple recent OIA requests I have submitted or followed on FYI.org.nz, including those relating to:
• ACC dispute-resolution legal spend and internal metadata governance
• Fluoride supply chain and risk accountability
• Vaccine safety monitoring and pharmacovigilance oversight

Across these different policy areas, a similar response pattern appears:
• Requests framed around verification, internal process, or governance
• Agency replies stating that no information is held,
• Accompanied by general policy statements, but
• Without clear confirmation of whether any internal evaluation or consideration occurred.

In this case, the Ministry did not explicitly answer the confirmation question asked in part 4 of the request (whether any formal evaluation occurred), instead relying on a general statement about not reviewing “media stories.”

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What this request did not seek

This request did not:
• assert the accuracy of the FDA-related claims,
• ask the Ministry to change policy,
• seek medical advice or conclusions, or
• ask for opinions on vaccine safety.

It asked a narrow governance question: whether internal assessment or correspondence existed, and if not, confirmation of that fact.

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Why this fits a broader transparency issue

As with other recent OIA work:
• ACC has confirmed multi-million-dollar legal expenditure without corresponding internal metadata structures;
• Councils release fluoride Safety Data Sheets but defer upstream risk and supply-chain accountability;
• Central agencies increasingly rely on “information not held” responses without clarifying search scope or internal consideration.

Individually, each refusal may be lawful.
Collectively, they raise questions about how internal risk awareness, evaluation, and accountability are documented — or not documented — across public agencies.

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Next steps

I am considering referral of this decision to the Office of the Ombudsman to review whether the response adequately addressed the confirmation sought under the Act.

This annotation is provided for public awareness and transparency only, and will be updated if further information or review outcomes occur.

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All information above is drawn directly from the Ministry of Health’s response dated 16 December 2025 and the publicly available FYI.org.nz request thread.

Subject: Complaint under s28(3) Official Information Act – Ministry of Health refusal (Ref: H2025076512)

To: complaints@ombudsman.parliament.nz
From: Spencer Jones

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Complaint under section 28(3) of the Official Information Act 1982

Agency: Ministry of Health – Manatū Hauora
OIA reference: H2025076512
Decision date: 16 December 2025

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1. Introduction
I am writing to request an investigation and review under section 28(3) of the Official Information Act 1982 into the Ministry of Health’s refusal of my OIA request dated 3 December 2025.

The Ministry refused the request in full under section 18(g)(i), asserting that the information requested is not held and that there are no grounds to believe it is held by another agency.

While I accept that agencies may lawfully refuse requests where information is genuinely not held, I consider that the Ministry’s response did not adequately address the confirmation sought under the Act, and that the refusal raises issues of process, interpretation, and compliance with statutory duties, particularly sections 13, 18, and 18(e)/(g).

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2. Summary of the request
My request sought confirmation of whether any internal consideration, assessment, correspondence, or review had occurred within the Ministry of Health or Medsafe following widely reported claims in late November 2025 regarding a U.S. FDA internal memo and paediatric COVID-19 vaccine safety.

The request was deliberately narrow and structured to avoid policy debate. It specifically included a fallback confirmation request (point 4), asking that if no documents existed, the Ministry:
• explicitly confirm this under section 18(e), and
• confirm whether the Ministry or Medsafe had formally evaluated the claims referred to in the media coverage.

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3. The Ministry’s response
The Ministry refused the request under section 18(g)(i) and added the statement:

“The Ministry of Health has not and does not intend to review COVID-19 vaccines or the programme based on media stories.”

No documents were released, and no partial information was provided.

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4. Grounds for complaint
This complaint is not about the substance of vaccine policy. It concerns whether the Ministry properly discharged its obligations under the OIA.

(a) Failure to adequately address the confirmation sought
My request explicitly asked for confirmation of whether any formal evaluation had occurred if no documents were held.

The Ministry’s response relied on a general policy statement about not reviewing “media stories,” but did not clearly confirm whether:
• any internal awareness, triage, or consideration occurred, even at a preliminary level; or
• no such consideration occurred at all.

Ombudsman guidance makes clear that agencies must answer the request actually made, including confirmation where requested, and not substitute broader policy statements in place of statutory confirmation.

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(b) Conflation of “media reporting” with the subject of the request
The request did not ask the Ministry to respond to media stories as such. It asked whether claims reported in the media triggered any internal consideration or correspondence.

By framing the refusal around not responding to “media stories,” the Ministry appears to have recharacterised the request, rather than addressing whether internal evaluation occurred.

This distinction matters for OIA purposes.

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(c) Unclear search scope and adequacy
The response does not indicate:
• what systems or repositories were searched,
• whether Medsafe records were included,
• whether internal correspondence, briefing logs, or pharmacovigilance monitoring records were checked.

While agencies are not required to detail searches in every response, the absence of any explanation here makes it difficult to assess whether reasonable steps were taken before relying on section 18(g)(i).

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(d) Pattern of reliance on “information not held” responses
This request sits within a wider pattern observable across recent FYI.org.nz OIA requests (including my own and others’) where agencies rely on section 18(g) while simultaneously making general statements about policy position, without confirming internal evaluative processes.

I raise this not as an allegation of bad faith, but because it suggests a systemic issue of OIA interpretation, suitable for Ombudsman guidance.

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5. What I am asking the Ombudsman to review
I respectfully request that the Ombudsman consider whether:
1. The Ministry adequately addressed the confirmation sought under point 4 of the request.
2. The reliance on section 18(g)(i) was appropriate in circumstances where a confirmation (rather than documents) was sought.
3. The Ministry properly interpreted and applied its duty to assist under section 13.
4. The response sufficiently distinguished between:
• declining to engage with media commentary, and
• confirming whether internal consideration or evaluation occurred.

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6. Outcome sought
I am not seeking disclosure of sensitive material or policy advice.

If the Ombudsman finds the complaint justified, I would welcome:
• a recommendation that the Ministry reconsider the request, or
• guidance clarifying the scope of confirmation obligations under sections 18(e) and 18(g).

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7. Attachments
I attach:
• My original OIA request (3 December 2025)
• The Ministry of Health response dated 16 December 2025

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Thank you for considering this complaint. I am happy to provide any further information if required.

Ngā mihi nui,

Spencer Jones
[contact details]

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Why this complaint is strong
• It does not argue facts, only process.
• It aligns with Ombudsman case law on confirmation, duty to assist, and recharacterisation of requests.
• It avoids emotive language or policy advocacy.
• It fits squarely within the Ombudsman’s mandate.

Public Annotation – Impact of U.S. FDA memo on COVID-19 vaccine safety monitoring (NZ)

This Official Information Act request sought to determine whether **New Zealand health authorities** undertook any **internal risk assessment, policy review, correspondence, or evaluation** in response to media reporting in late November 2025 about a U.S. FDA internal memo concerning paediatric COVID-19 vaccine safety.

The request asked whether, following that reporting, **any internal consideration occurred** within New Zealand agencies responsible for medicines regulation or health policy, and if no documents existed, sought **explicit confirmation** of that position.

In its response, **Ministry of Health** (including **Medsafe**) advised that:

* The Ministry **does not hold documents** evidencing any internal risk assessment, policy review, or correspondence arising from the reported U.S. FDA memo.
* The Ministry stated that it **has not and does not intend to review COVID-19 vaccines or the vaccination programme on the basis of media reporting**.
* Accordingly, the request was refused under section 18(g) of the Official Information Act on the basis that the information sought is **not held**.

No documents were released, and no partial disclosures were identified.

For the public record, this response establishes that **media-reported international regulatory developments did not trigger a documented internal review or assessment** within the Ministry of Health or Medsafe during the period requested. It also clarifies that New Zealand authorities distinguish between **formal regulatory signals** and **media coverage** when determining whether to initiate internal evaluation.

The requester subsequently sought Ombudsman review. The **Office of the Ombudsman** determined that the Ministry’s response had provided the confirmation sought (namely, that no such evaluation occurred) and that there was **no further OIA matter requiring investigation**.

This request is therefore complete and closed.