Revised: 25 August 2021

COVID-19

Approval status of COVID 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 infomation please go to www.health.govt.nz or see a description of the Medsafe approval process for COVID-19 vaccines.

Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech) concentrate for injection 0.5 mg/mL

Approval pathway: rolling new medicine application

Status: Approved under section 23 of the Medicines Act, with conditions on 3 February 2021. Extension of indications to allow use in adolescents aged 12 to 15 years old approved under section 23 of the Medicines Act, with updated conditions on 21 June 2021.

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

Below is a table that outlines the status of the conditions of approval. To view the current conditions, please refer to the Gazette Notice.

Status of condition Number of the condition as stated in the Gazette Notice
Completed 1, 3, 8, 19, 22-24, 30, 31, 39, 43, 44, 50, 53
Under review 5-21, 26-29, 32-38, 40-42, 45-49, 51
Monthly/ongoing 2, 4, 25, 52, 54, 56-58


Completed = information has been received, reviewed and deemed to fulfil the condition.
Under review = information has been received and is currently being reviewed.
Ongoing = information is received at regular intervals, when it becomes available or upon request.

COVID-19 Vaccine Janssen, suspension 5 x 1010 VP/0.5 mL

Approval pathway: rolling new medicine application

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

Documents:

See also: Viral Vector Vaccines

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

Approval pathway: rolling new medicine application

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

Documents:

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

Approval pathway: rolling new medicine application

Status: Application received, some data under evaluation, further data to be provided by sponsor.

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