133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
12 March 2025
Erika Whittome
By email: [FYI request #29775 email]
Ref:
H2025061333
Tēnā koe Erika
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 13 February 2025 for:
“Your responses have not supplied the requested info under the Act.
the link says RNA "can be genetic material". The request for info is a "yes" or "no" question.
I would like to narrow down the scope of this question: Is the mRNA in this particular
product genetic material?
When I look at the safety data sheet of other medicines, eg Panadol, the excretion is
shared and published on the safety data sheet. Kindly share the grounds for this product
information being withheld under section 9(2)(b)(ii) before I consider a complaint to the
Ombudsman.
This is a generic article not pertaining to this particular product. The link with no substantial
answer for this product. Again, when I look at the safety data sheet of other medicines, eg
Panadol, the excretion and half-life is published.”
The European Commission’s definition of genetic material is
‘Any material of plant, animal,
microbial or other origin that carries genetic information and that passes it from one generation to
the next’. mRNA vaccines do not meet this definition: https://ec.europa.e u/health/
scientific_committees/opinions_layman/electromagnetic-
fields2015/en/glossary/ghi/genetic-material.htm#:~:text=English%20%5Ben%5D-
,Genetic%20material,%2C%20development%2C%20behaviour%2C%20etc.
Medsafe is aware of claims that mRNA contain excessive DNA, which could result in integration
of residual DNA into the human genome. The scientific consensus is that there is no evidence to
support this. The Australian Therapeutic Goods Administration has published information that
addresses this claim: www.tga.gov.au/news/media-releases/addressing-misinformation-about-
excessive-dna-mrna-vaccines.
Datasheet section 5.2 Pharmacokinetic Properties is not required for vaccines. Other non-clinical
data relating to Comirnaty is withheld under 9(2)(b)(ii) of the Act in this case as its release would
likely unreasonably prejudice the commercial position of the person/third party who supplied the
information. To assist with your request, you may wish to refer to the following response provided
by the Ministry in response to a similar request: www.health.govt.nz/system/files/2021-10/
h202106950_-_response.pdf. In particular, please refer to pages 111 to 115.
I trust this information fulfils your request. 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
m
ade 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.
Nāku noa, nā
Chris James
Group Manager
Medsafe
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