133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
27 November 2025
Erika Whittome
By email: [FYI request #32518 email]
Ref:
H2025075229
Tēnā koe Erika
Response to your request for official information Thank you for your follow up request under the Official Information Act 1982 (the Act) to the
Ministry of Health – Manatū Hauora (the Ministry) on 8 November 2025 for:
“You have supplied a summary report
www.pfizer.com/sites/default/files/plsr-
studies/C4591015%20Plain%20Language%20Study%20Results%20Summary%20%28PL
SRS%29%20Phase%202-4.pdf
I have requested the actual report that the NZ govt received, not a summary version .
Kindly supply the requested information.”
The Ministry recognises the public interest in this matter and must balance this with our other
considerations under the Act. As such, the summary information is made available to help inform
the public.
When a sponsor (Pfizer) submits information of this nature, it is done so with the expectation that
regulators (Medsafe) will use it solely for assessment purposes. The material is proprietary
information. Releasing it would breach contractual confidentiality obligations, would likely harm
Pfizer’s commercial interests, and could discourage Pfizer or other companies from supplying
complete data to Medsafe in future regulatory submissions. For these reasons, the requested
study report received by the Ministry, titled ‘
A Study of RNA Vaccine (BNT162b2) Against
COVID-19 in Healthy Pregnant Participants [A Phase 2/3, Placebo-Controlled, Randomized,
Observer-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a SARS-CoV-2
RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years
of Age and Older]’ is withheld in full under the following sections of the Act:
• Section 9(2)(a), to protect the privacy of natural persons; and,
• Section 9(2)(ba)(i), to protect information that is subject to an obligation of confidence
and making it available would likely prejudice the supply of similar information, or
information from the same source.
I have considered the countervailing public interest in release in making this decision and do not
consider it outweighs the need to withhold at this time.
Although the full primary paper has not yet been published, further information regarding the trial
including results can be found on the Clinical Trials website at:
www.clinicaltrials.gov/study/NCT04754594. The information on this site is made available with
the company’s permission.
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
Ministry website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests. Nāku noa, nā
Chris James
Group Manager
Medsafe
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