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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

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

The product is a prescription medicine proposed for prevention of COVID-19 disease caused by SARS-CoV-2 in adults and adolescents from 18 years of age and older.

COVID-19 Vaccine Janssen is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Spike (S) protein, stabilized in its prefusion conformation.

The application was received by Medsafe on 8 December 2020. The application has undergone two rounds of request for information.  The application is being considered for provisional consent under section 23 of the Medicines Act 1981 with proposed conditions.

The 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 all the particulars and information submitted by the applicant, and weigh the likely therapeutic value of the medicine against the risk, and the appropriateness of the conditions proposed for consent.

The application has previously been considered by the Committee at the 110th meeting on 13 April 2021. It has been referred again under section 22 of the Medicines Act 1981 to the Committee as new  information relating to the safety of COVID-19 Vaccine Janssen has been provided by the applicant, specifically related to the risk of rare clotting adverse events, otherwise referred to as Vaccine-Induced Thrombotic Thrombocytopenia (VITT) or Thrombosis with Thrombocytopenia Syndrome (TTS).

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General business

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Date of next meeting