COVID-19: Assessing and approving the vaccines

Find out how COVID-19 vaccines have been assessed and approved in New Zealand. Safety, efficacy and quality of vaccines are reviewed before being approved.

Last updated: 29 October 2021

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How the COVID-19 vaccines are assessed

Medsafe is New Zealand’s medicines safety authority. It evaluates applications for all new medicines, including vaccines, to make sure they meet international standards and local requirements.

COVID-19 vaccines are being held to the same standards and requirements as all vaccines before they get full approval.

Medsafe will only recommend a medicine is approved to use in New Zealand if it meets these standards. If approval is granted, it will either be full approval under section 20 of the Medicines Act 1981, or provisional approval under section 23.

What Medsafe assess

Medsafe focuses on three key areas when assessing a vaccine:

  • safety
  • efficacy
  • quality.

Its assessment includes looking at:

  • manufacturing and quality control information
  • pre-clinical data
  • results from clinical trials.

Streamlining the approval process

We’re moving quickly to make sure New Zealand gets the best protection against COVID-19, but this doesn’t mean cutting any corners.

Medsafe has made changes to its vaccine assessment and approval process so it’s more efficient. Medsafe has been:

  • assessing large volumes of in-depth data from pharmaceutical companies as it becomes available. Usually pharmaceutical companies send all the data once all the studies have been completed
  • talking to and getting responses from pharmaceutical companies as soon as it can. For example, Medsafe asked Pfizer to respond to its questions within a week – usually companies have up to four months to respond.

What is provisional approval

Provisional approval was included in the Medicines Act so people in New Zealand can get early access to medicines if it’s to meet an urgent clinical need.

It allows a vaccine to be used with conditions in place. This restricts how the vaccine is used by health professionals depending on the supporting data available at the time.

We expect most vaccines will be given provisional approval because data to support the longer-term safety and efficacy of COVID-19 vaccines is not yet available.

Provisional approval of the Pfizer vaccine

The Pfizer vaccine (Comirnaty) has been provisionally approved (with conditions) for use in New Zealand.

This means it’s been formally approved after a thorough assessment, but Pfizer must give Medsafe ongoing data and reporting to show that it meets international standards.

The approval process

The process Medsafe went through to assess whether the Pfizer vaccine could be approved to use in New Zealand.

  1. Medsafe started getting clinical data from Pfizer in November 2020.
  2. Medsafe streamlined its assessment and approval process. Pfizer gave data as it became available — rather than sending all the data once the studies had been completed.
  3. Medsafe assessed all available data to support the safety, efficacy and quality of the vaccine. This included assessing manufacturing and quality control information and results from large clinical trials.
  4. Following this assessment, Medsafe asked the Medicines Assessment Advisory Committee (MAAC) for a final recommendation regarding approval.
  5. MAAC reviewed Medsafe’s assessment. It agreed that the Pfizer vaccine should be given provisional approval (with conditions). Conditions include Pfizer giving Medsafe ongoing data and information, such as additional clinical trial and manufacturing data.
  6. Pfizer agreed to these conditions. Medsafe formally made the decision to provisionally approve the vaccine in New Zealand on 3 February 2021 and the provisional approval was renewed on 28 October 2021.
  7. Medsafe will continue to monitor the safety and efficacy of the vaccine as it’s used. It will assess ongoing data and reporting, such as large clinical trials across the world and reporting by healthcare professionals and people who have received the vaccine.

Medsafe – COVID-19 vaccine evaluation and approval process
Medsafe – COVID-19 vaccine safety monitoring process

Provisional approval of other vaccines

Medsafe has granted provisional approval of the Janssen (Johnson & Johnson) COVID-19 vaccine and the AstraZeneca COVID-19 vaccine for individuals aged 18 and over.

Provisional approval does not mean that we have committed to using either of these vaccines in New Zealand. Medsafe’s provisional approval is the first step, with further consideration required by Cabinet on options for the use of these vaccines.

If the vaccines contain new organisms

If any of the COVID-19 vaccines arriving into New Zealand contain a new organism, the Environmental Protection Authority (EPA) will be involved. They’ll need to approve the import, development and field testing or release under the Hazardous Substances and New Organisms Act 1996 (HSNO Act).

EPA have a rapid approval pathway for any vaccines that are, or contain, new organisms which includes genetically modified organisms. They can look at applications at pace where needed and are working with Medsafe and Ministry for Primary Industries (MPI) in preparation for the vaccines.

Environmental Protection Agency – New organisms

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