Official Information Act Request
Requester’s details
Date: 14 August 2023
Name: Chris McCashin
Email: [FYI request #23558 email]
Reference number: ENQ-46512-V1G5K2
Tēnā koe Chris
I refer to your request, which was transferred to the Environmental Protection Authority
(EPA) on 7 August 2023. You have asked for:
Covid-19 Vaccine Approval. Please provide the following:
- Pfizer application to ERMA per the HSNO Act
- Approval / reporting documents
The information you have requested concerns the BioNTech/Pfizer SAR-CoV-2 vaccine
BNT162b2 (COMIRNATYTM).
The Environmental Risk Management Authority (ERMA) was the predecessor of the EPA.
The EPA is now responsible for regulating new organisms under the Hazardous Substances
and New Organisms Act 1996 (HSNO Act). If a vaccine contains a new organism or a
genetically modified organism, it must be approved by the EPA for release into the
environment.
The Determination request, the EPA Staff Assessment, and the Decision document for
BNT162b2, may all be found at the following link, under the ‘Application Documents’
heading:
HSNO application register | EPA
Further information describing the characteristics of the BioNTech/Pfizer vaccine, and the
regulatory role of the EPA is available here:
The spike protein and the Pfizer vaccine | EPA
I hope this information is helpful. You have the right to seek an investigation and review by
the Ombudsman of this decision. You can contact the Ombudsman on 0800 802 602, or by
email at [email address]
If you have any further queries, please do not hesitate to contact us via
[email address]
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We may publish your request and our response on our website,
www.epa.govt.nz. We make
OIA responses available so others can read more about the work we do and the questions
we are asked. Any information that might identify you wil be removed to protect your privacy.
Nāku noa nā
Dr Christopher Hill
General Manager, Hazardous Substances and New Organisms
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Document Outline
