How COVID-19 vaccines are approved

COVID-19 vaccines used in New Zealand must comply with international and local standards for quality, safety and effectiveness.

Who decides if a vaccine can be used

In New Zealand, applications for all new medicines (including vaccines) are assessed by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

Medsafe is responsible for regulating all medicines and medical devices in New Zealand. They are part of the Ministry of Health.

Medsafe will only approve a vaccine for use in New Zealand once they are confident it complies with international standards and local requirements for quality, safety and efficacy.

There is no ‘emergency use authorisation’ in New Zealand.

Medsafe's role in the response to COVID-19 (external link)

Who’s supporting Medsafe to make decisions

Because COVID-19 vaccines have been developed quickly and use new technologies, Medsafe is seeking expert advice from the COVID-19 Vaccine Advisory Group. Medsafe can also choose to refer vaccines to the Medicines Assessment Advisory Committee for a final recommendation about approval.

Medicines Assessment Advisory Committee (external link)

What happens when long-term research is not available

As data to support the longer-term safety and effectiveness of COVID-19 vaccines is not yet available, any approvals are likely to be provisional. This means there may be restrictions on how the vaccine can be used and who it can be offered to.

If a vaccine is granted provisional approval, pharmaceutical companies must provide more information (from clinical trials, for example) as it becomes available.

Medsafe’s vaccine evaluation and approval process (external link)

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