Moderna announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA Covid-19 vaccine, Spikevax, in a 50 µg dose, two-dose series, for active immunization to prevent Covid-19 caused by SARS-CoV-2 in children aged 6-11 years.

"The TGA authorization for the use of our Covid-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorization for the use of our vaccine in this age group. We are grateful to the TGA for their diligence and the Government of Australia for its continued confidence in our mRNA platform," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are grateful for the opportunity to provide protection against Covid-19 to this important age group, keeping children safe and able to continue life as normally as possible."

Professor Robert Booy from the Immunisation Coalition commented, "I welcome this decision by the TGA and look forward to the uptake of vaccination in children increasing even more to provide protection of children and maximize school attendance."

Moderna's vaccine has already received regulatory approval for adults and adolescents in Australia. On 9 August 2021, the TGA granted provisional registration to the Moderna Covid-19 Vaccine for active immunization to prevent Covid-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. On 3 September 2021, the provisional registration was extended to individuals 12 years of age and older.