Revised: 7 February 2023
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 (Pfizer-BioNTech): 12 years and older
- Comirnaty (Pfizer-BioNTech): 5 years and older
- Comirnaty (Pfizer-BioNTech): 6 months to 4 years
- Comirnaty Original/Omicron BA.1 (Pfizer-BioNTech): 12 years and older
- Comirnaty Original/Omicron BA.4/5 (Pfizer-BioNTech): 12 years and older
- COVID-19 Vaccine Janssen
- Vaxzevria (AstraZeneca)
- Nuvaxovid (Novavax)
- Spikevax (Moderna)
Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech):
12 years and older
Concentrate for injection 30 µg/0.3 mL (purple cap, must dilute)
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
- Gazette notice
- Data Sheet (PDF, 22 pages, 596 KB)
- Consumer Medicine Information (PDF, 4 pages, 82 KB)
- Risk Management Plan update 7 February 2023 (PDF 210 KB, 8 pages)
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 (Pfizer-BioNTech): 5 years and older
Solution for injection 30 µg/0.3 mL (grey cap, do not dilute)
Concentrate for injection 10 µg/0.2 mL (orange cap, must dilute)
Status
Provisional approval granted 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
- Gazette Notice 30 µg/0.3 mL
- Gazette Notice 10 µg/0.2 mL
- Data sheet (12 years of age and older) (PDF, 24 pages, 513 KB)
- Consumer Medicine Information (12 years of age and older) (PDF, 4 pages, 156 KB)
- Data sheet (5 to 11 years of age) (PDF, 26 pages, 550 KB)
- Consumer Medicine Information (5 to 11 years of age) (PDF, 4 pages, 152 KB)
- Dear Healthcare Professional Letter (PDF, 2 pages, 813 KB)
- Risk Management Plan update 7 February 2023 (PDF 210 KB, 8 pages)
Comirnaty (Pfizer-BioNTech): 6 months to 4 years
Solution for injection 3 µg/0.2 mL (maroon cap, must dilute)
Status
Provisional approval granted under section 23 of the Medicines Act with
conditions on 24 November 2022, valid until 3 November 2023.
Approved indication
Active immunisation to prevent coronavirus disease 2019 (COVID-19)
caused by SARS-CoV-2, in infants and children aged 6 months to 4
years.
Documents
- Gazette Notice
- Risk Management Plan update 7 February 2023 (PDF 210 KB, 8 pages)
Comirnaty Original/Omicron BA.1 (Pfizer-BioNTech): 12 years and older Solution for injection 15/15 µg/0.3 mL
Approval pathway
New medicine application
Status
Provisional approval granted under section 23 of the Medicines Act with
conditions on 21 December 2022, valid until 3 November 2023.
Approved indication
A booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2,
in individuals 12 years of age and older who have previously received at least a
primary vaccination course against COVID-19.
The use of this vaccine should be in accordance with official recommendations.
Documents
- Gazette Notice
- Risk Management Plan update 7 February 2023 (PDF 210 KB, 8 pages)
Comirnaty Original/Omicron BA.4/5 (Pfizer-BioNTech): 12 years and older Solution for injection 15/15 µg/0.3 mL
Status
Provisional approval granted under section 23 of the Medicines Act with
conditions on 21 December 2022, valid until 3 November 2023.
Approved indication
A booster dose for active immunisation to prevent COVID-19 caused by SARS-CoV-2,
in individuals 12 years of age and older who have previously received at least a
primary vaccination course against COVID-19.
The use of this vaccine should be in accordance with official recommendations.
Documents
- Gazette Notice
- Risk Management Plan update 7 February 2023 (PDF 210 KB, 8 pages)
COVID-19 Vaccine Janssen
Suspension for injection 5x1010
VP/0.5 mL
Status
Provisional approval renewed under 23(4) of the Medicines Act with conditions
on 6 April 2022, valid until 7 April 2024
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
- Gazette notice
- Data Sheet (PDF, 15 pages, 420 KB)
- Consumer Medicine Information (PDF, 4 pages, 178 KB)
- Risk Management Plan (PDF, 10 pages, 151 KB)
See also: Viral Vector Vaccines
Vaxzevria (AstraZeneca)
Solution for injection 5 x 1010 VP/0.5 mL
Status
Provisional approval renewed under 23(4) of the Medicines Act with conditions
on 28 April 2022, valid until 29 April 2024.
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
- Gazette notice
- Data Sheet (PDF, 15 pages, 160 KB)
- Consumer Medicine Information (PDF, 5 pages, 126 KB)
- Dear Healthcare Professional Letter (PDF, 3 pages, 215 KB)
- Risk Management Plan (PDF 14 pages, 304 KB)
See also: Viral Vector Vaccines
Nuvaxovid (Novavax)
Solution for injection, 5 µg/0.5 mL
Status
Provisional approval granted under section 23 of the Medicines Act with
conditions on 18 August 2022.
Approved indication
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused
by SARS-CoV-2 in individuals 12 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
Documents
- Gazette notice
- Data sheet (PDF 12 pages, 354 KB)
- Consumer Medicine Information (PDF 4 pages, 240 KB)
- Dear Healthcare Professional Letter (PDF 1 page, 222 KB)
- Risk Management Plan (PDF 7 pages, 260 KB)
Spikevax (Moderna)
Suspension for injection 0.2 mg/0.5 mL
Status
Provisional approval granted under section 23 of the Medicines Act with conditions
on 17 June 2022.
Approved indication
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused
by SARS-CoV-2 in individuals 12 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
Documents