20 November 2025
Attention: John Armstrong
By email:
[FYI request #32476 email]
Tēnā koe John
Official information request for information relating to the grant of provisional consent to the
Comirnaty vaccine under s 23 of the Medicines Act 1981
Our Ref: OIA-2526057
I refer to your official information request dated 4 October 2025 for:
1. Legal advice and internal correspondence between Crown Law and the Ministry of Health,
and the Department of the PM and cabinet (DPMC), and Medsafe, concerning the grant of
provisional consent to Comirnaty (Pfizer/BioNTech Covid-19 vaccine) under s23 of the
Medicines Act 1981, including:
2. Any advice or opinion regarding the requirement in s23 (pre-amendment) that consent be
limited to “the treatment of a limited number of patients.”
3. Any assessment of whether the provisional consent for Comirnaty was intra vires or ultra
vires s23. Any briefings to DPMC, Medsafe and Ministry of Health.
4. Crown Law reports relating to the urgent passage of the Medicines Amendment Act 2021
(enacted 19 May 2021), including:
a. The legal advice justifying the removal of the “limited number of patients” wording.
b. Any advice about the need for retrospective validation of provisional consents already
granted (including Comirnaty).
c. Any advice on alternative options that were considered but not adopted.
d. Communications with external regulators (e.g., Australia’s TGA or international
regulators) regarding whether provisional consent in New Zealand was consistent with
the scope of s23 at the time.
5. Any risk assessments prepared between November 2020 and June 2021 regarding the
legality, legal risk, or judicial review exposure of provisional consents under s23.
On 28 October 2025, we wrote to notify you of an extension of time to respond to your request to
21 November 2025. The reason for the extension was because your request is for a large quantity
of information and meeting the original time limit would unreasonably interfere with our
operations.
Leve l 2 Justice Centre, 19 Aitken Street, Wellington 6011 | PO Box 2858 or DX SP20208, Wellington 6140, New Zealand | +64 4 472 1719 | crownlaw.govt.nz
8882803
2
Decision
You have asked for copies of any legal advice provided to various agencies, and any internal Crown
Law correspondence, relating to the grant of provisional consent to the sale or supply or use of the
Comirnaty Covid-19 vaccine. We have identified all Crown Law electronic files that might contain
information relevant to your request. We have then reviewed each of those files to determine
whether any documents within the scope of your request are held by Crown Law. Some of the files
we reviewed contain a significant number of documents. Where this is the case, we undertook
searches using key words appropriate to the information you have requested.
We have identified 80 documents that were either reviewed and commented on or drafted by
Crown Law within the scope of your request. We have also identified 915 emails referring to
provisional consent under section 23 of the Medicines Act that are relevant to your request.
The information referred to above contains privileged material and is subject to legal professional
privilege. We have therefore decided to withhold this information under section 9(2)(h) of the
Official Information Act 1982 to maintain legal professional privilege. In withholding this
information, we consider that the interest in maintaining legal professional privilege is not
outweighed by other considerations which render it desirable, in the public interest, to make that
information available.
Right to review
You have the right to seek an investigation and review by the Ombudsman of this decision.
Information about how to make a complaint is available at
www.ombudsman.parliament.nz or
freephone 0800 802 602.
If you wish to discuss this decision with us, please feel free to contact
[Crown Law Office request email].
Nāku noa, nā
Crown Law
Mark Bryant
Team Manager and Crown Counsel
8882803
