133 Molesworth Street
PO Box 5013
New Zealand T
+64 4 496 2000 W
9 September 2021
By email: [FYI request #16339 email]
Dear El Zorro
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 12 August for:
“I'm looking for a Ministry assessment of the pharmacokinetic and toxicity profile of the
spike protein. The links you referred me to did not match with the summarized finding of
Pfizer's animal study. And the EMA link doesn't exist anymore.
Can you please confirm you are in possession of Pfizer's study:
"SARS-CoV-2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Summary state- ment of the
pharmacokinetic study 2020."
And if so please release any evaluation regarding it.”
The Ministry has no record of sending you information regarding Pfizer's animal study or an EMA
link. It is possible this information was released to you through a request made under a different
Medsafe is unable to confirm that it is in possession of the referenced study as no specific study
number has been provided. However, Medsafe does hold pharmacokinetic study data for
Comirnaty COVID-19 vaccine provided by Pfizer.
The document New Medicine Application Evaluation Report – Non-Clinical
is attached as
Appendix 1. This is being released with information withheld. Information has been withheld
under section 6(b)(ii) of the Act as its release would prejudice information entrusted to the
Government of New Zealand on a basis of confidence by any international organisation, section
9(2)(b)(ii) of the Act where its release would likely unreasonably prejudice the commercial
position of the person who supplied the information, and section 9(2)(g)(ii) of the Act to maintain
the effective conduct of public affairs through the protection of such Ministers, members of
organisations, officers, and employees from improper pressure or harassment.
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-
Chris James Group Manager
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