Official Information Act request — records concerning handling of OIA request H2026082615

Subject: Official Information Act request — records concerning handling of OIA request H2026082615

 

I request the following information under the Official Information Act 1982, relating to the Ministry of Health / Medsafe handling of OIA request H2026082615, responded to by Chris James on 10 June 2026.

The response concerned my request for records identifying COVID-19 vaccine safety signals investigated by Medsafe, CARM, or the COVID-19 Vaccine Independent Safety Monitoring Board, including trigger sources, assessment notes, escalation records, meeting minutes/advice papers, outcome decisions, advice to decision-makers, and SOP/policy/process documents underlying Medsafe’s published safety-signal process. The response refused parts of the request under sections 18(d) and 18(g)(i) of the Act.  

Please provide:

All internal correspondence, emails, Teams messages, file notes, memos, or records relating to the processing, scoping, interpretation, consultation, review, approval, or sign-off of OIA request H2026082615.

All records identifying searches undertaken for information within scope of H2026082615, including:

search terms used;

repositories, drives, mailboxes, systems, databases, or folders searched;

staff, teams, or business units asked to search;

dates searches were undertaken;

records of search results, including nil-result searches.

All records explaining or supporting the decision to refuse part of the request under section 18(d), including records identifying:

what publicly available material was relied on;

how the Ministry assessed that the publicly available material answered the request;

whether the publicly available CV-ISMB Final Report was checked against the specific requested categories, including trigger sources, assessment notes, escalation records, meeting minutes/advice papers, outcome decisions, and advice to Ministers, CV TAG, or programme decision-makers.

All records explaining or supporting the decision to refuse points 3 and 7 under section 18(g)(i), including records showing:

how the Ministry determined that it did not hold escalation records;

how the Ministry determined that it did not hold any SOP, policy, or process document underlying Medsafe’s Figure 3 “process for investigating a potential COVID-19 vaccine safety signal”;

whether Medsafe, CARM, the Ministry, the CV-ISMB Secretariat, or any relevant pharmacovigilance staff were consulted before reaching that conclusion;

whether transfer under section 14 of the Act was considered.

All drafts of the response letter, including tracked changes, comments, legal or managerial review comments, and approval/sign-off records.

All records identifying the documents attached to the response, including any cover notes, attachment lists, release schedules, document descriptions, or records explaining why those documents were selected as responsive.

All records relating to the statement that “knowing which safety signals have been investigated does not provide useful information to anyone wanting to know the safety profile of a medicine.” Please include any internal discussion, review, or rationale for including that statement in the response.  

All records relating to the Ministry’s interpretation of my original request, including any consideration of whether the request sought:

a list of investigated signals;

underlying signal-assessment records;

process/escalation records;

decision records;

advice to Ministers, CV TAG, or programme decision-makers.

For clarity, this request is not seeking a duplicate copy of the final response letter or the attachments already provided, except where those documents contain annotations, drafts, metadata, release schedules, or internal comments relevant to the handling of H2026082615.

Please provide the information in electronic form. If any information is withheld, please identify the withholding ground relied on and provide sufficient contextual information to understand the nature of the withheld material.

Tracy Lynch
[email protected]