Dear Health New Zealand,

I am writing to request the following information under the Official Information Act 1982:

The gold standard safety reports associated with each vaccine currently included in the New Zealand childhood immunisation schedule. This should include, but not be limited to:

Results from randomized controlled trials (RCTs) conducted during the pre-licensure phase, including Phase 1, 2, and 3 studies.

Data from post-authorization surveillance, including both passive and active surveillance systems.

Results from any real-world evidence (RWE) studies conducted on these vaccines in New Zealand or internationally.

Information on any international collaborative studies that have been used to assess the safety of these vaccines.

Reports from regulatory bodies (such as Medsafe or international equivalents) that were used in the approval process for these vaccines.

Any additional safety studies or reports that Te Whatu Ora considers to be part of the gold standard for vaccine safety assessment for the childhood immunisation schedule vaccines.

Dates these vaccines were approved

Yours faithfully,
Chris