133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
17 January 2022
Paul Roberts
By email:
[FYI request #17848 email]
Ref:
H202117154
Tēnā koe Paul
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health (the Ministry) on 6 December 2021 for:
“…please provide the date the Ministry/Medsafe received such documentation from
Pfizer showing the Cumulative Analysis of Post-authorization Adverse Event Reports,
the same or similar to what was released in the above referenced document?”
The Ministry and Medsafe have received several requests for information related to the
Cumulative Analysis Report and its publication in the United States. A comprehensive response
that explains its genesis and relevance in New Zealand, and addresses your questions has
been published at:
www.health.govt.nz/system/files/documents/information-
release/h202117570_response_0.pdf
As the published response notes, the Cumulative Analysis Report was created to meet a
specific legal process in the United States. As it has no relevance to New Zealand’s statutory
processes, it was not provided by Pfizer. However, as the response also notes as a part of the
provisional consent for the Comirnaty COVID-19 vaccine granted in New Zealand under the
Medicines Act 1981, Pfizer has provided the same data, albeit in a form that meets the
company’s legal obligations in New Zealand. Therefore, your request is refused in part under
section 18(e) of the Act because the information requested does not exist, and in part under
section 18(d) because a response to the matters you have raised is publicly available.
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.
Nāku noa, nā
Jan Torres
Acting Manager OIA Services
Office of the Director-General
