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.
The authorisation and availability of COVID-19 vaccines depend on:
- Data being available to review, particularly in relation to safety and effectiveness.
- When Medsafe approval is granted and for which groups
- 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.
For further information as to how we got COVID-19 vaccines so quickly see this Insight.
What does provisional approval mean?
The mRNA COVID-19 vaccine by Pfizer/BioNTech was granted provisional consent for use in New Zealand on 3 February 2021. Having met the initial criteria, this was renewed on 28 October 2021 for a further two years. 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. This approval can be extended to include other groups as clinical trial data are obtained.
This approval differs from that granted in other countries, such as the US, UK and in Europe, in which these vaccines were initially granted ‘emergency-use approval’ based on early data and an urgent need to start vaccinating soon as safely possible. New Zealand was in the fortunate position 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.
Under New Zealand legislation, there is no ability to have different levels of approval for one vaccine or medicine. For example, Medsafe cannot grant full consent for Pfizer vaccine for adults and maintain provisional consent for adolescents 12 to 15 years old (or in future applications such as 5 – 11 year olds). This is one of the reasons why Medsafe has not moved to full approval in New Zealand for this vaccine at this time. By renewing the provisional consent, once satisfied that all criteria have been met, Medsafe can move to full approval at anytime during the two year period. This is a routine process that has been applied previously to other medicines in New Zealand..
For further information about how our first COVID-19 vaccine was granted approval in New Zealand and elsewhere, see this blog.
Approval for use in children
The same stringent approval processes also apply for the use of vaccines in children. Medsafe has approved a Comirnaty for use for those aged 12–15 years following evaluation of clinical trial data showing, as expected, that the vaccine is both safe and effective in 12–15-year-olds and review of safety data from other countries where the vaccine has already been approved in this age group, including the UK and the US.
Further clinical trials are underway or planned for younger age groups, eventually from the age of 6 months. It is anticipated that Pfizer will apply to Medsafe for approval for use of a paediatric formulation of Comirnaty vaccine in children aged 5-11 years in due course based on preliminary clinical trial data.