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Our role in approving COVID-19 vaccines

Our role in vaccine approving the vaccines used in Aotearoa New Zealand is limited.

If a vaccine contains a new organism or a genetically modified organism (GMO), it must be approved by us.

Determining if the vaccine contains a new organism

  • We can determine whether a vaccine contains a new organism or a GMO, but only if a manufacturer or importer of the vaccine asks us or if they are directed to do so by the Ministry for Primary Industries (MPI).
  • If a vaccine contains a new organism, including a GMO, then the manufacturer or the importer must get an approval from us before it can be used in New Zealand. We assess the risks versus benefits of releasing a new organism vaccine into New Zealand’s environment. 

We do not assess its chemical properties

  • Human medicines are exempt from the hazardous substances part of the Hazardous Substances and New Organisms Act 1996 – which we administer – so we do not assess a vaccine’s chemical properties.
  • We rely upon the information provided to us by manufacturers and do not conduct a chemical analysis of the product.

A manufacturer or importer may still be subject to standard import and compliance requirements from MPI.

Pfizer-BioNTech vaccine Plus

The Pfizer-BioNTech COVID-19 vaccine BNT162b2 has been engineered using technologies that can also be used to create genetically modified organisms.

Pfizer applied to us to formally determine whether its COVID-19 vaccine is considered a new organism in New Zealand.

Decision-making committee decided it is not a new organism

In February 2021, an EPA decision-making committee examined the characteristics of the Pfizer vaccine, including what it does, how it is made, and whether it could be considered a new organism.

The committee found that, because the vaccine is unable to replicate itself, it does not meet the definition of a new organism. This means it is not subject to regulation as a GMO.

Cleared for importation

On approval for its use as a medicine by Medsafe, and receiving permission under the Biosecurity Act 1993 from the Ministry for Primary Industries, the vaccine was cleared to come into New Zealand.

COVID-19: Vaccine effectiveness and protection (Ministry of Health)

Get behind the science

Read about the vaccine and its regulatory journey through the EPA.

The spike protein and the Pfizer vaccine

Application to obtain a determination of whether an organism is a new organism

Determination on Pfizer vaccine
Agreements for other vaccines Plus

The New Zealand Government agreed in advance to buy from four different suppliers of COVID-19 vaccines.

Read the purchasing agreements with four vaccine suppliers (Ministry of Health website)

Pfizer is the only manufacturer to apply for a determination of whether their vaccine is considered a new organism

Comirnaty (Pfizer/BioNTech COVID-19 vaccine)

Medsafe gave the Pfizer vaccine a provisional approval for use in New Zealand on 3 February 2021.

Janssen vaccine

Medsafe gave the Janssen vaccine a provisional approval on 7 July 2021.

AstraZeneca vaccine

Medsafe gave the AstraZeneca vaccine a provisional approval on 22 July 2021.

The AstraZeneca is a two-dose vaccine. It can be taken by anyone over 18 years of age wanting a different option than Pfizer or if they cannot get the Pfizer vaccine.

What you need to know about the AstraZeneca vaccine (Ministry of Health)

Novavax

The application is still being evaluated by Medsafe.

Read the approval status of COVID vaccines applications (Medsafe website)
Roles of other agencies in importing vaccines Plus

 

Medsafe

The Medicines and Medical Devices Safety Authority (Medsafe) is responsible for regulating therapeutic products in New Zealand. Medsafe’s role is to assess the risks or benefits of any vaccine and see if it’s safe for use in humans.

Ministry for Primary Industries

MPI monitors the importation of any vaccine under both the Hazardous Substances and New Organism Act 1996 (HSNO Act), and the Biosecurity Act.

MPI is responsible for compliance regarding the EPA’s decision-making on new organisms under the HSNO Act. Border inspectors ensure that imports do not contain any new organisms not approved for importation by the EPA.

MPI is responsible for issuing import permits under the Biosecurity Act 1993 for shipments of organisms or items that contain biological materials that are potentially hazardous to New Zealand’s primary industries.
Responses to COVID-19 requests under the Official Information Act 1982 Plus

This page has our responses to Official Information Act 1982 (OIA) requests. They explain why a vaccine isn’t a hazardous substance or new organism, and our role in approving the COVID-19 vaccine.

Information about whether a COVID-19 vaccine is a new organism – 23 September 2021 (PDF, 332KB)

COVID-19 vaccines – 20 October 2021 (PDF, 218KB)

COVID-19 vaccines – 28 October 2021 (PDF, 137KB)

COVID-19 vaccines – 2 December 2021 (PDF, 152KB) 

Ingredients in a COVID-19 vaccine - 22 December 2021 (PDF, 367KB)

Read about Official Information Act requests and accessing our information
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