1

Welcome

2

Apologies

3

Declaration of conflicts of interest

4

Applications for consent to distribute a new medicine under section 20 / 23 / 24 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

4.1

Nuvaxovid (Novavax SARS-CoV-2 rS Vaccine with Matrix-M1 Adjuvant), 10µg/mL, solution for injection
(Biocelect New Zealand Ltd)

This product is a prescription medicine proposed for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The proposed indication for Nuvaxovid 10 micrograms/mL solution for injection is for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older.

Nuvaxovid is a vaccine containing the active ingredient SARS-CoV-2 rS protein, formulated with a Matrix-M1 adjuvant) and works by triggering the immune system to protect against COVID-19.

The application was accepted by Medsafe on 3 March 2021. The application has undergone two rounds of request for information. The application is being considered for provisional consent under section 23 of the Medicines Act 1981 with proposed conditions.

The application is being referred to the Committee for independent advice as to whether the Minister of Health should grant provisional consent for the proposed indications. The Committee is also asked to consider the appropriateness of the conditions proposed for consent.

5

General business

6

Date of next meeting