133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
6 November 2025
Erika Whittome
By email: [email address]
Ref:
H2025073810
Tēnā koe Erika
Response to your request for official information
Thank you for your requests under the Official Information Act 1982 (the Act) to the Ministry of
Health – Manatū Hauora (the Ministry) on 8 October 2025 for information regarding COVID-19
vaccine safety. You requested:
“This study C4591015 on pregnant women is listed in the Medsafe Risk Management
Report https://www.medsafe.govt.nz/COVID-19/Comirnaty-RMP.pdf
To assess safety and immunogenicity in pregnant women.
In addition, exploratory objectives include:
(a) To describe the immune response in infants born to breastfeeding
women vaccinated with prophylactic COVID-19 mRNA vaccine during
pregnancy.
(b) To describe the safety of maternal immunisation in infants born to
breastfeeding women who received COVID-19 mRNA vaccine during
pregnancy.
1. Please would you share the results of the study C4591015 and the MoH's (or other
agency's) review of this study as captured in meeting minutes, memos or any other
correspondence? Specifically, I refer to all the information the MoH holds on C4591015
since the study's completion in 2022 and the study's results on pregnant women and
breastfed infants.
2.Please share the meeting minutes (I assume from 2021) for when the Pfizer report dated
April 2021 on BNT162b2 PREGNANCY AND LACTATION CUMULATIVE REVIEW was
examined and reviewed by the Ministry of Health. A copy of this report is here:
phmpt.org/wp-content/uploads/2023/04/125742_S2_M1_pllr-cumulative-review.pdf
The MoH encouraged vaccination for pregnant woman, so I assume this report was
reviewed prior to the encouragement messaging from the MoH for pregnant women to
receive BNT162b2 injections.”
Clinical results of the study you have requested above (C4591015) are available publicly here,
the results section begins on page 10
: www.pfizer.com/sites/default/files/plsr-
studies/C4591015%20Plain%20Language%20Study%20Results%20Summary%20%28PLSRS%
29%20Phase%202-4.pdf.
In terms of Ministry review of the study, the Ministry has not specifically reviewed this study in
isolation and therefore does not hold documents within the scope of your request. 18(g)(i) of the
Act applies as the information requested is not held by the Ministry and there are no grounds for
believing it is held by another agency subject to the Act.
In relation to part two of your request, there was no meeting held in relation to this report hence
no meeting minutes created; therefore section 18(e) of the Act applies as the information
requested does not exist. Medsafe is a regulator, not a research body and therefore, have not
conducted clinical studies on vaccines or medicines.
As you have been previously advised in response H2023031808, the report you refer to titled
PREGNANCY AND LACTATION CUMULATIVE REVIEW, BNT162b2, Cumulative Review from
Pharmacovigilance Database, was produced for the Food and Drug Administration (FDA) only
and was not received by Medsafe from Pfizer.
As per the conditions imposed on the provisional approval for Comirnaty vaccines, the
manufacturer has been providing Medsafe with information on the safety of this medicine,
including use in pregnancy and lactation.
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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