133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
11/02/2021
Virginia Crawford
By email:
[FYI request #14492 email]
Ref:
H202100619
Dear Virginia Crawford
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 1 February 2021
for follow up information relating to your previous request for regarding COVID vaccines.
You asked the following:
“These vaccines are all still being trialed [sic] and some of these trials will not be completed
until 2023.
Does this mean that Medsafe will recommend that these vaccines be used "under
emergency", as is happening in most of the world? Surely they cannot be fully licensed in
New Zealand while they are still being trialed [sic]?
It is not unusual for companies to apply for medicines to be approved before the completion of all
clinical trials. Medsafe’s evaluation and approval process for COVID-19 vaccines is described
here:
www.medsafe.govt.nz/COVID-19/vaccine-approval-process.asp
One vaccine (Comirnaty) has been provisionally approved for use in New Zealand to address an
urgent clinical need. Available online are:
• Minutes of the Medicines Advisory Committee that considered the application by Pfizer
New Zealand Ltd
: www.medsafe.govt.nz/committees/maac/Recommendation109-
2February2021.htm
• Gazette notice authorising the sale, supply and use of the vaccine:
www.medsafe.govt.nz/COVID-19/Comirnaty-Gazette.pdf
• Data sheet for health professionals:
www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf
• Consumer information:
www.medsafe.govt.nz/Consumers/CMI/c/comirnaty.pdf
I trust this information fulfils your request. 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
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