Statutory Authority, Due Process, and Rule Changes for COVID-19 Vaccine Safety Oversight

Statutory Authority, Due Process, and Rule Changes for COVID-19 Vaccine Safety Oversight
From:
InLandsAirWater Counsel
Ann Kifo – Attorney acting under instruction
Private Trust Correspondence
PO Box 265
Queenstown
To:
Official Information Act Team
Te Whatu Ora – Health New Zealand
[email protected]
Dated today
This request is made under the Official Information Act 1982.

I seek official information relating to the statutory authority, due process requirements, and any changes to rules or procedures governing how Te Whatu Ora (and predecessor entities) identified, assessed, escalated, or declined to act on COVID-19 vaccine safety signals, including clustered or anomalous adverse outcomes.

This request concerns process and governance only. It does not seek personal clinical records.

1. Statutory Authority

Kindly identifyy the specific statutory provisions relied upon between 2021–2024 that authorised:
– Any deviation from standard medicines safety monitoring or escalation processes;
– Any discretion to downgrade, defer, or not escalate adverse outcome signals.

If no statute expressly authorised such deviation, please confirm this.

2. Due Process Obligations

Kindly provide documents setting out:
– The minimum due process steps required when adverse outcome signals emerged;
– Whether those steps were mandatory or discretionary;
– How compliance with those steps was verified, audited, or assured.

3. Rule Changes, Waivers, or Modifications

Kindly provide copies of any policy instruments, directives, guidance, exemptions, or internal instructions issued between 2020–2024 that altered normal vaccine safety monitoring, escalation, or disclosure processes.

For each, please identify the author, approving authority, date in force, and the legal advice or statutory basis relied upon.

4. Signal Detection and Escalation Thresholds

Kindly confirm whether defined thresholds or triggers existed requiring escalation when:
– Statistically unusual adverse outcomes occurred;
– Concentrated outcomes were associated with a single vaccinator, clinic, or short time period.

If such thresholds existed, please provide the documents defining them and how compliance was ensured.

If no such thresholds existed, please explain how this was consistent with statutory safety obligations.

5. Consideration of Non-Clinical Factors

Kindly provide documents showing whether programme continuity, public confidence, messaging, or reputational risk were considered when deciding whether to escalate, investigate, or disclose safety concerns.

Please identify the statutory authority permitting such considerations.

6. Accountability and Oversight

Kindly identify:
– The role(s) responsible for ensuring statutory compliance;
– Any internal reviews, audits, or concerns raised regarding failures to follow required process or due diligence.

If any information is withheld, please specify the exact statutory withholding ground relied upon, explain how the public interest test was applied, and release all reasonably severable material.

If this request is likely to exceed time limits, please advise which parts may be refined to enable compliance.

By:Ann Kifo

8/01/26
Attorney acting under instruction
InLandsAirWater Counsel