133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
3 March 2025
Anna
By email: [FYI request #29635 email]
Ref:
H2024059033
Tēnā koe Anna
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 – Manatū Hauora (the Ministry) on 21 December 2024. You requested:
“Timeframe: This request covers the period from 2021 to the present.
Pursuant to the Official Information Act 1982, I request the following information regarding
discussions, documentation, or correspondence within the Ministry of Health, or any other
relevant government department or state body, relating to the Pfizer mRNA COVID-19
vaccine between 2021 and the present:
DNA Contamination: Any documents, emails, or meeting minutes discussing the presence,
risks, or implications of DNA contamination in the Pfizer mRNA vaccine.
SV40: Any documents, emails, or meeting minutes discussing the presence or implications
of SV40 sequences in the Pfizer mRNA vaccine.
Frameshift Mutations: Any documents, emails, or meeting minutes discussing frameshift
mutations or related concerns in relation to the Pfizer mRNA vaccine.
IgG4 Conversion: Any documents, emails, or meeting minutes discussing the conversion of
IgGs to a relatively high proportion of IgG4 in vaccinated individuals, its implications, or
related research.
Nucleocapsid Antibody Inhibition: Any documents, emails, or meeting minutes discussing
the inhibition of nucleocapsid antibody production in vaccinated individuals, its implications,
or related research.
Additional Information:
Scope and Keywords: I request searches of emails, meeting minutes, internal memos, or
reports containing the listed keywords: “DNA contamination,” “SV40,” “frameshift
mutations,” “IgG4,” and “nucleocapsid antibody”.”
Please note, al medicines undergo significant evaluation by Medsafe before being approved for
use in New Zealand and must meet both New Zealand and international standards for safety,
effectiveness and quality. Due to this, Medsafe would not routinely test every individual medicine
prior to its release to the market in New Zealand. Suppliers of medicines to New Zealand market

are responsible for testing them according to approved specifications.
Medsafe is aware of claims that mRNA vaccines contain ‘excessive levels of DNA’
encapsulated in lipid nanoparticles, and the claim that this presents a safety risk. These seem to
arise following a pre-print publication by Kevin McKernan et al. Preprint publications have not yet
undergone a thorough review and critical analysis by scientific peers.
This claim has been rejected by the scientific community at large. In response to the publication
preprint and associated claims, experts have noted that to date, claims that COVID-19 mRNA
vaccines can alter DNA in people lack a biologically plausible mechanism to explain how this
would happen. Further, they note that neither the preprint by McKernan et al. nor the other
studies cited in the article provided evidence for the claim that COVID-19 mRNA vaccines contain
significant DNA contamination or that the vaccines can alter DNA in people.
Regarding Comirnaty, release testing according to registered specifications is conducted on
every batch of Comirnaty prior to release. The amount of residual DNA is controlled with an
appropriately chosen and qualified specification limit for DNA, tested via qPCR; only batches that
meet this specification are released.
Therefore, Medsafe does not hold any information discussing the removal or altering or
contamination of DNA from the Comirnaty vaccine. Therefore, this part of your request is refused
under section 18(g)(i) of the Act.
Please also note, the reports provided to Medsafe from the vaccine suppliers are withheld in full
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
releasing information and consider that it does not outweigh the need to withhold at this time.
You may also be interested in information regarding Pfizer COVID-19 vaccine DNA
contamination which is published on the Ministry's website here:
•
www.health.govt.nz/information-releases/information-regarding-pfizer-covid-19-vaccine-
dna-contamination.
•
www.health.govt.nz/information-releases/covid-19-vaccine-and-dna-contamination.
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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