Moderna's COVID vaccine gets Australian regulator nod for use in kids 6-11
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Moderna (NASDAQ:MRNA) said the Therapeutic Goods Administration (TGA) in Australia granted provisional registration for the use of mRNA COVID-19 vaccine Spikevax, in a 50 Âµg dose, two-dose series, for children aged six to 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," said Moderna (MRNA) CEO StÃ©phane Bancel.
The vaccine was investigated in an ongoing phase 2 "KidCOVE" study. The study population was divided into three age groups (6 to under 12 years, 2 to under 6 years, and six months to under 2 years).
The data submitted to the TGA showed that vaccination of children six to under 12 years of age with a 50 Î¼g mRNA-1273 primary series is linked 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.
On Aug. 9, 2021, the TGA granted provisional registration to the vaccine for 18 years of age and older. On Sept. 3, 2021, the provisional registration was extended to individuals 12 years of age and older.
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