How are COVID-19 vaccines authorised in New Zealand?

All medicines approved for use in New Zealand, including vaccines, go through strict review by Medsafe to make sure they meet local and international safety and efficacy guidelines.

Once Medsafe has reviewed all available data, it makes a recommendation to the NZ Government as to whether a medicine can be granted approval in New Zealand. More comprehensive information on this process is available on the Medsafe website.

Vaccinations against COVID-19 using the mRNA COVID-19 vaccine, Comirnaty™ (from Pfizer/BioNTech)  have begun. Currently, vaccinations are being given to those at highest risk of exposure to SARS-CoV-2 (the virus that causes COVID-19) and their close household contacts. There will be sufficient doses of this vaccine for everyone in New Zealand. See here for the current vaccine roll-out plan.

The exact date when other vaccines will be available in New Zealand is unknown. Their arrival depends on:

  • Data being available to review, particularly in relation to safety and effectiveness 
  • When Medsafe approval is granted
  • When the vaccine can arrive in New Zealand. 
  • To obtain approval for use in New Zealand, each vaccine needs to meet strictly defined safety and efficacy criteria.

The mRNA COVID-19 vaccine by Pfizer/BioNTech was granted provisional approval for use in New Zealand on 3 February 2021. This means that it has been approved for use in a defined group and on the condition that Medsafe continues to receive and review further data about this vaccine’s safety and effectiveness. Click here to find out more.

This approval differs from that granted in other countries, such as the US, UK and in Europe, in which these vaccines were granted ‘emergency-use approval’ based on early data and an urgent need to start vaccinating soon as safely possible. New Zealand has been fortunate to be able to wait, while receiving the most current clinical trial and post-licensure data, to make the decision to approve the use of this vaccine. Once sufficient data has been obtained, it is likely that Medsafe will convert the provisional consent to full consent in due course.

Watch this video from the Ministry of Health with Dr Ashley Bloomfield and MedSafe's Chris James for more on the vaccine approval process in New Zealand. 
 

Last updated: 08 April 2021