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 (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

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

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

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

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

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

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

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

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

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