Published: 23 December 2022
Committees
SUMMARY OF RECOMMENDATIONS FROM THE 122ND MEETING OF THE MEDICINES ASSESSMENT ADVISORY COMMITTEE HELD BY VIDEOCONFERENCE ON 16 DECEMBER 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))
4.1a Comirnaty Original/ Omicron BA.1 (tozinameran/ riltozinameran), suspension for injection, 15 micrograms/ 15 micrograms/ 0.3 mL, Pfizer New Zealand Limited.
The Committee recommended that the delegate of the Minister of Health grant provisional consent to the distribution of Comirnaty Original/Omicron BA.1, 15/15 microgram/0.3 mL for individuals 12 years of age and older under section 23 of the Medicines Act 1981. The Committee agreed with Medsafe’s proposal that the provisional consent be valid until 3 November 2023 and agreed with the conditions for approval proposed by Medsafe.
4.1b Comirnaty Original/ Omicron BA.4-5 (tozinameran/famtozinameran), suspension for injection, 15 micrograms/ 15 micrograms/ 0.3 mL, Pfizer New Zealand Limited.
The Committee unanimously agreed to recommend that the delegate of the Minister of Health grant provisional consent to the distribution of Comirnaty Original/Omicron BA.4-5, 15/15 microgram/0.3 mL for individuals 12 years of age and older under section 23 of the Medicines Act 1981. The Committee agreed with Medsafe’s proposal that the provisional consent be valid until 3 November 2023 and agreed with the conditions for approval proposed by Medsafe.
