133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
11 December 2023
Nikita Mahendra
By email: [FYI request #24493 email]
Ref:
H2023033006
Tēnā koe Nikita
Response to your request for official information Thank you for your request under the Official Information Act 1982 (the Act) to Manatū Hauora
(the Ministry of Health) on 15 November 2023 as a follow up to the information regarding the
Comirnaty (Pfizer) COVID-19 vaccine provided to you under OIA H2023032536. Each part of
your request is responded to below:
1. Which agency performs the tests in NZ
The Comirnaty (Pfizer) COVID-19 vaccine is not tested in New Zealand. The manufacturing and
testing steps for the Comirnaty vaccine can be found on Medsafe’s website at:
www.medsafe.govt.nz/regulatory/DbSearch.asp.
2. What is the acceptable level of DNA alllowed in these injections?
Medsafe assesses medicine applications against internationally established criteria, such as
guidelines published by the EMA (European authority), the FDA (USA), Health Canada, the TGA
(Australia) and the International Conference on Harmonisation (ICH).
Information relating to this part of your request is withheld under section 9(2)(ba)(i) of the Act, 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 consider that it
does not outweigh the need to withhold at this time.
There is a large amount of information publicly available about the vaccine, including on the
Medsafe website here:
www.medsafe.govt.nz/COVID-19/medicine-approval-process.asp.
3. Who are these scientific community or experts that you refer to in your response.
While the Act allows New Zealanders to ask for information from Ministers and government
agencies, there is no requirement for agencies to create new information, compile information
they do not hold or provide or prove an opinion. Your question appears designed to engage in a
debate about the COVID-19 vaccine, rather than a request for official information. The Act does
not support requests where an opinion, comment, argument, or hypothetical statement is put to
the Ministry for response, couched as a request for information.
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
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
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