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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

 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.

The product is a prescription medicine proposed 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 16 to 17 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