Published: 14 December 2021
Committees
SUMMARY OF RECOMMENDATIONS FROM THE 111TH MEETING OF THE MEDICINES ASSESSMENT ADVISORY COMMITTEE HELD IN WELLINGTON ON TUESDAY 15 JUNE 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)
|
| 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 conditions. The Committee agreed to Medsafe’s proposal that the provisional consent should have an effect of nine months. The Committee recommended that supply and use of the vaccine should be restricted to circumstances where there is no other approved COVID-19 vaccine available or clinically indicated. |
