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Welcome

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Apologies

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Declaration of conflicts of interest

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Applications for consent to distribute a new medicine under section 20 / 23 / 24 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

4.1

 Xevudy (sotrovimab), concentrate injection solution for infusion, 500 mg in 8 mL (62.5mg/mL), GlaxoSmithKline NZ Ltd

Xevudy (sotrovimab) is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death.

Sotrovimab is a neutralising monoclonal antibody which binds to a highly conserved spike protein epitope which is present in SARS-CoV-2.

The application is being referred to the Committee for independent advice as to whether the Minister of Health should grant provisional consent. The Committee is also asked to consider the appropriateness of the conditions and the duration proposed for consent.

4.2

Nuvaxovid adolescent extension; 12 to <18 years of age, injection, 10 μg/mL, Biocelect New Zealand Limited

Nuvaxovid is a vaccine containing the active ingredient SARS-CoV-2 rS protein, formulated with a Matrix-M1 adjuvant. These components together elicit B- and T- cell immune responses, including neutralising antibodies, which protect against COVID-19.

Nuvaxovid is a prescription medicine, proposed for the prevention of COVID-19 as caused by SARS-CoV-2. This application proposes to extend nuvaxovid COVID-19 vaccine indication to include individuals 12 to <18 years of age.

This application is being referred to the Committee for independent advice as to whether the Minister of Health should grant provisional consent for the proposed indications. The Committee is also asked to consider the appropriateness of the conditions and the duration proposed for consent.