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 Original/ Omicron BA.1 (tozinameran/riltozinameran), suspension for injections, 15 micrograms/15 micrograms/0.3mL, Pfizer New Zealand Limited.

Comirnaty Original/ Omicron BA.1 is a bivalent vaccine containing riltozinameran and tozinameran.

The proposed vaccine indicated for use in individuals 12 years of age and older and who have received a primary vaccination course against Coronavirus disease 2019 (COVID-19).

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

4.2

Comirnaty Original/ Omicron BA.4-5 (tozinameran/famtozinameran), suspension for injection, 15 micrograms/15 micrograms/0.3 mL, Pfizer New Zealand Limited

Comirnaty Original/ Omicron BA.4-5 is a bivalent vaccine containing famtozinameran and tozinameran.

The proposed vaccine is indicated for use in individuals 12 years of age and older who have received a primary vaccination course against COVID-19.

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