The renewal of provisional approval is for a period of two years, until 3 November 2023.
Pfizer has met all obligations required to date by the conditions of the provisional approval granted in February this year. This included providing additional data about the clinical trials and vaccine monitoring.
By renewing the provisional approval, we will continue to receive and assess data from Pfizer about the administration of the vaccine around the world.
During the 2-year renewal period, Medsafe may grant full approval at any time, once Pfizer has submitted a relevant application and information.
Medsafe will continue to assess any supporting information against the appropriate standards as additional quality, safety and efficacy data is received and reviewed.
The remaining conditions relate to ongoing supply of clinical trial data, ongoing requirements for monitoring the use of the vaccine globally, specific batch test results for vaccine supplied in New Zealand, and reporting these to Medsafe on request.
Medsafe has a robust process for assessing quality, safety and efficacy data for all vaccines and medicines supplied in New Zealand. The same stringent measures are applied to COVID-19 vaccines and we do not take any shortcuts when it comes to the approval process. Provisional Consent renewal is routine and has been applied previously to other medicines. Provisional approval is limited to defined time period no longer than 2 years.
Medsafe will continue to prioritise the assessment of information for COVID-19 vaccines and will provide further updates when possible.