133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
10 May 2023
T +64 4 496 2000
W www.medsafe.govt.nz
Erika Whittome
By email: [FYI request #22655 email]
Ref:
H2023024581
Tēnā koe Erika
Response to your request for official information Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Haoura
(the Ministry of Health) on 2 May 2023 for information regarding a report on pregnancy and
lactation. You asked:
“There is a report from the Comirnaty manufacturer, Pfizer called PREGNANCY AND
LACTATION CUMULATIVE REVIEW, BNT162b2, Cumulative Review from
Pharmacovigilance Database, approved on 21 Apr 2021 (FDA-CBER-2021-5683-0779745).
125742_S2_M1_pllr-cumulative-review.pdf (phmpt.org)
Please confirm whether Pfizer or any other entity has provided information consistent with
the information and data contained in the above report to any New Zealand health or
government agency. If so please confirm which agency and on what date.
Please also confirm whether information, data or reports have been received from Pfizer or
any other entity on the effects of any of the Pfizer Covid 19 vaccines on male fertility. If so
please confirm to which agency and on what date.’’
As per the conditions imposed on the provisional approval for Comirnaty vaccines, the
manufacturer has been providing Medsafe with safety reports. Effects of medicines on pregnancy
and lactation is a topic of interest in these reviews. Male fertility is not a topic of interest as it has
not been identified as a safety signal. All reports received by the company including if there were
any on these topics are summarised in these reviews.
I trust this information fulfils your request. 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
Chris James
Group Manager
Medsafe
