Published: 14 December 2021

Committees

SUMMARY OF RECOMMENDATIONS FROM THE 110TH MEETING OF THE MEDICINES ASSESSMENT ADVISORY COMMITTEE HELD IN WELLINGTON ON THURSDAY 13 APRIL 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

COVID-19 Vaccine Janssen, 5 x 1010 virus particles (VP) in 0.5 mL suspension for injection (TT50-10862)
Janssen-Cilag (New Zealand) Limited

The Committee recommended that the Minister of Health should grant provisional consent to the distribution of this medicine under Section 23 of the Medicines Act 1981 with the imposed conditions proposed by Medsafe. The Committee agreed to Medsafe’s recommendation that the provisional consent should have an effect of nine months.

Secretary's note:

New relevant information, regarding the safety of COVID-19 vaccine Janssen, was available immediately subsequent to the MAACs recommendation. To ensure that this new information was considered by MAAC, the GM Medsafe, as the Ministers delegate, referred the application back to the MAAC under section 22(2) of the Act for further consideration.

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