133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
10 August 2021
Paul Jones
By email: [FYI request #16106 email]
Ref:
H202108644
Dear 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 16 July for information regarding the Pfizer Comirnaty vaccine.
Information in response to each part of your request is as follows.
1) Has Pfizer provided Genotoxicity studies?
2) Please provide the Genotoxicity study document.
Pfizer has not provided genotoxicity studies, therefore
the Ministry is unable to provide you with
any study documents. As such, this part of your request is refused under section 18(g)(i) of the
Act, 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.
3) Has Pfizer provided Reproductive Toxicology Studies?
4) Please provide the Reproductive Toxicology study document.
Pfizer has provided Reproductive Toxicology Studies. These are itemised in Appendix 1 to this
letter, and copies of the documents are enclosed.
5) Has the Ministry/Medsafe requested Genotoxicty study data from Pfizer?
Medsafe has not requested genotoxicity study data on the basis that it is not required according
to international guidelines. Other information provided by Pfizer sufficiently justifies the lack of
genotoxic potential of this vaccine and its ingredients.
6) Has the Ministry/Medsafe requested Reproductive Toxicology study data from Pfizer?
Reproductive Toxicology study data is included in the documentation provided in response to
questions three and four. This Reproductive Toxicology study data was not specifically
requested. Rather, it was included in the original dossier. Please note, this information is withheld
under section 9(2)(b)(ii) of the Act as it is commercially sensitive.
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. Yours sincerely
Chris James
Group Manager
Medsafe
Page 2 of 3
Appendix 1: List of documents for release
#
Date
Title
Decision on release
1
22 December
Study No. 20256434 - A
Some information withheld under
2020
Combined Fertility and
section 9(2)(a) to protect the privacy of
Developmental Study (Including
natural persons and 9(2)(b)(ii) where
Teratogenicity and Postnatal
its release would likely unreasonably
Investigations) of BNT162b1,
prejudice the commercial position of
BNT162b2 and BNT162b3 by
the person who supplied the
Intramuscular Administration in
information.
the Wistar Rat.
An excerpt of this document has been
provided, all pages deemed
commercially sensitive under the Act
have not been included.
2
15 December
Summary of Results from Study
Released in full.
2020
No. 20256434.
Page 3 of 3
