On Feb. 16, 2022, Moderna announced that the Therapeutic Goods Administration in Australia had granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a 50 ﾵg dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years.

Data submitted to the TGA demonstrated that vaccination of children 6 to under 12 years of age with a 50 ﾵg mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18-25 years old from the Phase 3 Cove study.