Published: 16 December 2021

Committees

SUMMARY OF RECOMMENDATIONS FROM THE 113TH MEETING OF THE MEDICINES ASSESSMENT ADVISORY COMMITTEE HELD IN WELLINGTON ON TUESDAY 14 DECEMBER 2021

4.

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

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

  The Committee recommended that the delegate of the Minister of Health should grant provisional consent to the distribution of these medicines under Section 23 of the Medicines Act 1981 with the conditions proposed by Medsafe. The Committee agreed to Medsafe’s proposal that the provisional consent should be valid until 3 November 2023.
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