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 0.5 mg/mL (30 μg/0.3 mL dose) concentrate for injection (TT50-10877), Comirnaty 0.1 mg/mL (30 μg/0.3 mL dose) solution for injection (TT50-10853/1), and Comirnaty 0.1 mg/mL (10 μg/0.2 mL dose) concentrate for injection (TT50-10853/1a)

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

4.2

Nuvaxovid 10 µg/mL solution for injection (TT50-10879)

The Committee unanimously agreed that a recommendation regarding approval of the changed medicine should be deferred until additional data to support clinical efficacy is provided by the sponsor.