Making sure COVID-19 vaccines are safe and effective

Before any vaccine is approved for use in New Zealand, it must meet international standards and local requirements for quality, safety and efficacy.

How COVID-19 vaccines are being developed

There’s never been this level of global collaboration amongst scientists and governments in vaccine development.

Vaccine companies have been sharing their data all over the world, which has sped up the research process. It has also led to a number of innovations, such as the use of the messenger RNA (mRNA) technology.

How COVID-19 vaccines are being tested and assessed

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

So COVID-19 vaccines can be made available as early as possible, Medsafe is streamlining its processes and assessing these vaccine applications ahead of normal applications.

Medsafe is:

  • in regular contact with pharmaceutical companies to prepare for applications
  • supporting pharmaceutical companies to apply in a consistent way
  • allowing 'rolling' applications – which means companies can submit sections as they are ready, rather than waiting until the whole application is complete
  • considering the assessment of an application from suitable overseas reports, if they are available.

How COVID-19 vaccines will be approved for use

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.

Any approvals are likely to be provisional, as data to support the longer-term safety and effectiveness of COVID-19 vaccines is not yet available. 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 would continue to provide Medsafe with more information (from clinical trials, for example) as it becomes available.

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

Who’s supporting Medsafe to make decisions

Because COVID-19 vaccines have been developed very 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 Assessement Advisory Committee (external link)

How the safety of COVID-19 vaccines will be monitored

Medsafe uses a range of methods to gather information on the safety and quality of medicines and vaccines after they have been approved.

Medsafe’s vaccine safety monitoring process (external link)

Where to find trustworthy information about vaccines

The Immunisation Advisory Centre (IMAC)

IMAC is a nationwide organisation based at the School of Population Health at The University of Auckland. It provides independent, factual information based on international and New Zealand scientific research about vaccine-preventable diseases the benefits and risks of immunisation.

The Immunisation Advisory Centre (external link)

Ministry of Health

The Ministry of Health leads New Zealand’s health and disability system, and has overall responsibility for the management and development of that system.

Vaccine information from the Ministry of Health (external link)

World Health Organization (WHO)

WHO is an agency of the United Nations, and is responsible for international public health.

Vaccine information from WHO (external link)

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