Kia ora, 

 

Thank you for your request for official information received on 4 October
2025 requesting: 

 

1/ Legal advice and internal correspondence between the Ministry of Health
and the Department of the PM and cabinet (DPMC), and Medsafe, and Crown
Law 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 Crown
law.

 

4/ Ministry of Health 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.

 

The Ministry of Health has decided to extend the period of time available
to respond to your request under section 15A of the Official Information
Act 1982 (the Act) as the consultations necessary to make
a decision on the request are such that a proper response to the request cannot reasonably be made within the original time limit.

You can now expect a response to your request on, or before, 17 November
2025.

 

You have the right, under section 28 of the Act, to ask the Ombudsman to
review my decision to extend the time available to respond to your
request. 

 

Ngâ mihi 

  

OIA Services Team

Ministry of Health  | Manatû Hauora 

M[1]inistry of Health information releases 

 

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References

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