Published: 17 July 2022
Committees
SUMMARY OF RECOMMENDATIONS FROM THE 118TH MEETING OF THE MEDICINES ASSESSMENT ADVISORY COMMITTEE HELD BY VIDEOCONFERENCE ON 1 JUNE 2022
4.0 Applications for consent to distribute a new medicine under section 23 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))
4.1. SPIKEVAX, Suspension for injection, 0.2 mg/mL (Adjutor Healthcare (NZ) Ltd
The Committee recommended that the delegate of the Minister of Health should grant provisional consent to the distribution of this medicine under section 23 of the Medicines Act 1981, with the conditions proposed by Medsafe. The Committee agreed to Medsafe’s proposal that the provisional consents should be valid for two years.
4.2 NUVAXOVID, Solution for injection, 10μg/mL (Biocelect New Zealand Ltd)
The Committee recommended that the delegate of the Minister of Health should grant provisional consent to the distribution of this medicine as both a heterologous and homologous booster under section 23 of the Medicines Act 1981, with the conditions proposed by Medsafe. The Committee agreed to Medsafe’s proposal that provisional consent should be valid until 4 November 2022.
4.3 Comirnaty, Suspension for injection, 0.1 mg/mL (Pfizer New Zealand Limited)
Comirnaty, Concentrate for injection, 0.5 mg/mL (Pfizer New Zealand Limited)
The Committee recommended that the delegate of the Minister of Health should grant provisional consent to the distribution of these changed medicines under section 23 of the Medicines Act 1981 with appropriate conditions. The Committee agreed to Medsafe’s proposal that provisional consents be valid until 3 November 2023.
