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) 30 micrograms/0.3 mL solution for injection
Comirnaty (COVID-19 mRNA vaccine) 10 micrograms/0.2 mL concentrate for injection
Pfizer New Zealand Limited

These products are prescription medicines proposed for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. The proposed indication for Comirnaty 30 micrograms/0.3 mL solution for injection is for use in individuals 12 years of age and older. The proposed indication for Comirnaty 10 micrograms/0.2 mL solution for injection is for use in children 5 to 11 years of age.

Comirnaty is a vaccine containing the mRNA-based active ingredient tozinameran (formally known as BNT162b2) and works by triggering the immune system to protect against COVID-19.

The application was formally accepted by Medsafe on 12 November 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