133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
M Bell
By email:
[FYI request #15177 email] Ref:
H202104534
Dear M Bell
Response to your request for official information Thank you for your request under the Official Information Act 1982 (the Act) on 15 April 2021 for
information relating to provisional consent. You specifically requested:
“1. What the Urgent clinical need is or is related to
2. A copy of all data, information, statistics and scientific proof which you used to decide
provisional consent was required to meet the urgent clinical need described in question 1”
The urgent clinical need is related to the global COVID-19 pandemic, and the potential need if
an outbreak occurs in New Zealand.
Any information relating to provisional consent is withheld in full under section 9(2)(b)(ii) of the
Act where its release would likely unreasonably prejudice the commercial position of the person
who supplied the information.
For more information regarding the vaccine approval process please refer to the following link:
www.medsafe.govt.nz/COVID-19/vaccine-approval-process.asp. Under section 28(3) of the Act you have the right to ask the Ombudsman to review any
decisions made under this request. The Ombudsman may be contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests. Yours sincerely
Chris James
Group Manager
Medsafe