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 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.