133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
14 June 2021
Virginia Crawford
By email:
[FYI request #15493 email] Ref:
H202106063
Dear Virginia Crawford
Response to your request for official information Thank you for your request under the Official Information Act 1982 (the Act) on 18 May for:
“I note that the Australian version of the Cominarty vaccine insert, states the following:
"This vaccine has provisional approval in Australia to prevent COVID-19 disease caused
by SARS-CoV-2 virus in adults and adolescents from 16 years of age and older. This
approval has been granted on the basis of short term safety and efficacy data. Evidence
of longer term efficacy and safety from ongoing clinical trials and vaccination in the
community continues to be gathered and assessed."
This essential information (or the appropriate New Zealand version of it) has NOT been
included in either of the two information leaflets (Data Sheets or CMI's) available in New
Zealand.
Without this information, persons vaccinated or to be vaccinated in New Zealand, do NOT
have proper INFORMED CONSENT.
Please explain discrepancy”
The provisional status of Pfizer vaccine in New Zealand is publicly available on the Ministry of
Health’s websit
e www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-
coronavirus/covid-19-vaccines/covid-19-vaccine-safety-and-approval/covid-19-assessing-and-
approving-vaccines. Information regarding the approval process can be found on the Medsafe
website
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
Nick Allan
Manager OIA Services
Office of the Director-General
Page 2 of 2
