1

Welcome

2

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

SPIKEVAX, Injection, suspension 0.2mg/mL Moderna COVID-19 mRNA Vaccine (Prescription)

Spikevax has been developed by US company Moderna in response to the global pandemic of SARS-CoV-2 virus that causes COVID-19. The active ingredient is an mRNA drug substance (elasomeran) encoding the pre-fusion stabilised spike glycoprotein (S) of the SARS-CoV-2 virus encapsulated in a lipid nanoparticle. The drug product is presented in a multidose vial that is stored frozen (-25 to -15°C) and does not require dilution prior to use.

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 duration proposed for consent.

4.2

NUVAXOVID, Injection, solution 10µg/mL (COVID-19 Vaccine with Matrix-M Adjuvant) (Prescription)

Nuvaxovid is a vaccine containing the active ingredient SARS-CoV-2 rS protein, formulated with a Matrix-M1 adjuvant) and works by triggering the immune system to protect against COVID-19.

Nuvaxovid is a prescription medicine proposed for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. Two separate but related applications have been made:

1. An application proposes to extend the dosing regimen to include a heterologous booster dose at least 10 weeks after completion of the primary vaccination course with another COVID-19 vaccine. The was initially referred to the MAAC at the 116^th
2. An application proposes to extend the dosing regimen to include a homologous booster dose at least 10 weeks after completion of the primary vaccination course with Nuvaxovid vaccine.

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

4.3

Comirnaty, Injection, suspension 0.1mg/mL (grey cap, do not dilute) 30 mcg/0.3 mL dose (Prescription),
Comirnaty (COVID-19 mRNA vaccine), Injection, concentrate 0.5mg/mL Pfizer-BioNTech (delivers 30 µg/0.3mL dose) (Prescription)

Comirnaty is a vaccine containing the mRNA-based active ingredient tozinameran (formally known as BNT162b2) and works by triggering the immune system to protect against COVID-19.

These product are a prescription medicines for prevention of COVID-19 disease caused by SARS-CoV-2. This application proposes an extension to the dosing regimen to include administration of a booster dose at least six months after completion of the primary vaccination course in individuals aged 12 to 15 years old.

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 extension to dosing regimen. The Committee is also asked to consider the appropriateness of the conditions and duration proposed for consent.

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General business

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Date of next meeting