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

Comirnaty (COVID-19 mRNA vaccine), 0.5 mg/mL (TT50-10853)Pfizer New Zealand Limited

The product is a high risk prescription medicine proposed for prevention of COVID-19 disease caused by SARS-CoV-2 in adults and adolescents from 16 years of age and older.

Comirnaty is a new vaccine employing a novel technology (mRNA) and works by triggering the immune system to protect against COVID-19 disease.

The application was received by Medsafe on 13 November 2020. The application has undergone one round of request for information.  The application is being considered for provisional consent under section 23 of the Medicines Act 1981 with the 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