A manufacturer or importer is required to have approval from us if a vaccine contains a new organism or genetically modified organisms (GMOs).
If a manufacturer considers that its vaccine does not contain a new organism or genetically modified organism, it may decide not to seek our approval. This could be based on similarities to previous new organism determinations we’ve made.
However, a manufacturer or importer may still be subject to standard import and compliance requirements from the Ministry for Primary Industries (MPI).
If a manufacturer applies to the us to test or release a vaccine containing a new organism or genetically modified organism, our Chief Executive has the discretion to consider such applications under a rapid approval pathway.
Under the rapid approval pathway, there is no public consultation. The final decision is published on our website.
If the application does not qualify to go through the rapid approval pathway, it would go through a full assessment pathway, including public notification, and potentially a public hearing.
Pfizer applied to us to formally determine whether its COVID-19 vaccine is considered a new organism in New Zealand.
The Pfizer-BioNTech COVID-19 vaccine BNT162b2 has been engineered using technologies that can also be used to create genetically modified organisms.
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.
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.
The Government has selected Pfizer as the country’s main vaccine provider, as its vaccine has been shown to be approximately 95% effective against symptomatic COVID-19, seven days after receiving the second dose.
COVID-19: Vaccine effectiveness and protection (Ministry of Health)
Get behind the science
Read about the vaccine and its regulatory journey through the EPA.
Agreements for other vaccines
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.
Medsafe gave the Janssen vaccine a provisional approval on 7 July 2021.
Medsafe gave the AstraZeneca vaccine a provisional approval on 22 July 2021.
The application is still being evaluated by Medsafe.
Read the approval status of COVID vaccines applications (Medsafe website)
Roles of different agencies in importing vaccines
Environmental Protection Authority
As New Zealand’s national regulator of new organisms, we play an important role in the introduction of vaccines (and other medicines) that are or that may contain new organisms into this country.
If requested to do so, we can determine if any vaccine or other medicine is, or contains, a new organism. If a vaccine contains a new organism, then an approval to release the vaccine into the environment must be obtained from us before it may be used in New Zealand. We assess the risks versus benefits of releasing a new organism vaccine into New Zealand’s environment. GMOs are also new organisms under the Hazardous Substances and New Organism Act 1996 (HSNO Act).
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.