Revised: 17 January 2022

COVID-19

Approval status of COVID-19 vaccines applications received by Medsafe

A Medsafe approval is one step in the process for accessing a COVID-19 vaccine. Once approved, the New Zealand Government then considers advice and makes decisions on when and for who a particular vaccine will be used as part of the COVID-19 immunisation programme. For more information, please go to the Ministry of Health website www.health.govt.nz or see a description of the Medsafe approval process for COVID-19 vaccines.

Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech): 12 years and older
Concentrate for injection 30 µg/0.3 mL


Status
Provisional approval renewed under 23(4) of the Medicines Act, with conditions on 28 October 2021, valid until 3 November 2023.

Approved indication
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV2, in individuals 12 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

Documents

Risk management plans (RMPs) set out the known safety information for a medicine and measures to monitor the safety of the medicine. RMPs include a summary of the known safety profile and risks, activities to minimise the risks, and plans to gain more information on the medicine.

See also: mRNA Vaccines

Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech): 5 years and older
Solution for injection 30 µg/0.3 mL
Concentrate for injection 10 µg/0.2 mL

Status
Approved under section 23 of the Medicines Act with conditions on 16 December 2021, valid until 3 November 2023.

Approved indications

Solution for injection 30 µg/0.3 mL (grey cap, do not dilute)
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV2, in individuals 12 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

Concentrate for injection 10 µg/0.2 mL (orange cap, must dilute)
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV2, in individuals 5 to 11 years of age.

The use of this vaccine should be in accordance with official recommendations.

Documents

COVID-19 Vaccine Janssen
Suspension for injection 5x1010 VP/0.5 mL


Status
Approved under section 23 of the Medicines Act with conditions on 7 July 2021.

Approved indication
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

Documents

See also: Viral Vector Vaccines

COVID-19 Vaccine AstraZeneca
Solution for injection 5 x 1010 VP/0.5 mL


Status
Approved under section 23 of the Medicines Act with conditions on 22 July 2021.

Approved indication
Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

Documents

See also: Viral Vector Vaccines

Novavax COVID-19 Vaccine
Solution for injection, 5 µg/0.5 mL


Approval pathway
Rolling new medicine application.

Status
Novavax has provided some data to Medsafe for the rolling assessment but still needs to provide further data as it becomes available. Timing for completing the assessment is dependent on when Medsafe receives all the data, the quality of the information provided, and the time taken by Novavax to respond to any requests for further information that may be required.  

Proposed indication
Active immunisation for the prevention of mild, moderate and severe disease caused by SARS-CoV-2 in adults ≥ 18 years of age.

The use of this vaccine should be in accordance with official recommendations.

Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /