133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
30 January 2024
Erika Whittome
By email:  [FYI request #25124 email]
Ref:
H2023033891
Tēnā koe Erika
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 | Manatū Hauora (the Ministry) on 11 December 2023.
On 29 January 2024, parts 1, 6, and 7 of your request were transferred to Health New Zealand -
Te Whatu Ora; however, upon further review, the Ministry is reconsidering the information
requested under questions 6 and 7. You wil  be advised in due course should a re-transfer be
required for these parts. We apologise for any inconvenience. Please find a response to each
remaining part of your request below:
The provisional approval in the Gazette for the Comirnaty medicine had 8 conditions here
https://www.medsafe.govt.nz/COVID-19/Comirnaty-Gazette-Oct-2021.pdf
Would you kindly share the evidence of these 8 conditions being approved?
2. Provide independent batch certification, such as UK National Institute for Biological
Standards and Control (NIBSC) certification, EU Official Control Authority Batch Release
(OCABR) certification, Australian TGA batch release assessment, or any other certification
agreed with Medsafe, on request for all batches distributed in New Zealand.
Certificates for last three deliveries are attached to this letter as Document 1. This is released to
you with some information withheld under section 9(2)(ba)(i ) of the Act, to protect information
that is subject to an obligation of confidence and making it available would likely damage the
public interest. Where information is withheld under section 9 of the Act, I have considered the
countervailing public interest in releasing information and consider that it does not outweigh the
need to withhold at this time.
3. Provide any reports on the duration of efficacy and the requirement for booster doses
within five working days of these being produced.
Data sheets were updated to include the need for booster vaccines. Please find the data sheet
for the Pfizer COVID-19 Comirnaty vaccine here:
www.medsafe.govt.nz/profs/datasheet/c/comirnatyinj.pdf
4. Provide any reports on efficacy including asymptomatic infection in the vaccinated group,
vaccine failure, immunogenicity, efficacy in population subgroups and results from post-
marketing studies, within five working days of these being produced.

The information you have requested is publicly available in the Pfizer COVID-19 Comirnaty
vaccine data sheets here: www.medsafe.govt.nz/profs/datasheet/c/comirnatyinj.pdf.

5. Provide the final Clinical Study Reports for Study C4591001 and Study BNT162-01 within
five working days of these being produced.

Due to the changes in disease landscape, evolving variants and introduction of booster doses,
the initially planned follow up period is no longer considered clinically relevant for C4591001
(Phase I/II/I I in adults and children 12 years and older), C4591007 (Phase I/I /II  paediatric), and
BNT162-01 (Phase I/I  in adults). This requirement was removed by Medsafe.

8. Perform the required pharmacovigilance activities and interventions detailed in the
agreed RMP and any agreed updates to the RMP. An RMP should be submitted at the
request of Medsafe or whenever the risk management system is modified, especially as the
result of new information being received that may lead to a significant change to the
benefit/risk profile or as the result of an important milestone being reached.

The published risk management plan (RMP) summary has been updated on Medsafe’s website
here: www.medsafe.govt.nz/searchResults.asp?q=RMP+summary.

I trust this information fulfils your request.  If you wish to discuss any aspect of your request with
us, including this decision, please feel free to contact the OIA Services Team
on: [email address].

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
Manatū Hauora website at: www.health.govt.nz/about-ministry/information-releases/responses-
official-information-act-requests.

Nāku noa, nā

Derek Fitzgerald
Acting Group Manager
Medsafe

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ACT
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RELEASED

Document Outline