1

Welcome

2

Apologies

3

Declaration of conflicts of interest

4

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 (tozinameran) concentrate for injection, 3 micrograms/ 0.2 mL, Pfizer New Zealand Limited (6 months to 4 years of age).

Comirnaty is a vaccine containing the active ingredient tozinameran based on SARS-CoV-2 spike glycoprotein (S) antigens encoded in RNA formulated in lipid nanoparticles.

Comirnaty is a prescription medicine, proposed for the prevention of COVID-19 as caused by SARS-CoV-2. This application proposes a new lower strength formulation to deliver a 3 micrograms dose, indicated for use in infants and children aged 6 months to 4 years old.

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

4.2

Comirnaty (tozinameran) concentrate for injection, 10 micrograms/ 0.2 mL dose, Pfizer New Zealand Limited (booster dose for children 5 to 11 years of age).

Comirnaty is a vaccine containing the active ingredient tozinameran based on SARS-CoV-2 spike glycoprotein (S) antigens encoded in RNA formulated in lipid nanoparticles.

Comirnaty is a prescription medicine, proposed for the prevention of COVID-19 as caused by SARS-CoV-2. This application proposes a change to extend the dosing regimen for Comirnaty COVID-19 vaccine to include a booster dose 6 months after completion of the primary course in children 5 to 11 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 changed medicine. The Committee is also asked to consider the appropriateness of the conditions and the duration proposed for consent.

5

General business

6

Date of next meeting