Provisional approval for Pfizer vaccine extended
Medsafe has now renewed the provisional approval for the Pfizer COVID-19 vaccine for 2 years, until 3 November 2023. Provisional Consent renewal is routine and has been applied previously to other medicines.
Provisional approval means the pharmaceutical company must meet certain conditions, including supplying more data from its clinical trials around the world as they progress.
To date, Pfizer has met all the conditions of the provisional approval granted in February 2021. As a result, this renewal removes a large number of these original conditions. The remaining conditions relate to the ongoing supply of clinical trial data, batch testing information, and ongoing requirements for monitoring the use of the vaccine globally and reporting to Medsafe.
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 the 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.
Medsafe can decide to grant full approval at any point in the next two years if and when Pfizer has submitted an application and provided the information required (including for all age ranges).
In renewing the provisional consent, Medsafe confirms that the benefits of the Pfizer COVID-19 vaccine outweigh the risks.
Please visit the Ministry of Health website for more information.
You can read more about the vaccine approval process on our website.