Moderna has reported that its Covid-19 vaccine, Spikevax (mRNA-1273), obtained provisional registration from the Therapeutic Goods Administration (TGA) in Australia for active immunisation to prevent Covid-19 in children of the age six to 11 years.
The authorised dosage of the messenger ribonucleic acid (mRNA) vaccine is a 50µg dose to be administered as a two-dose regimen.
Spikevax was analysed in the ongoing, observer-blind, randomised, placebo-controlled, expansion Phase II KidCOVE clinical trial.
It assessed the safety, reactogenicity, tolerability and effectiveness of two 50µg doses of the vaccine administered to healthy children at a gap of 28 days.
The trial population was categorised into three groups based on age: six to under 12 years, two to under six years and six months to below two years.
According to the findings submitted to the TGA, inoculation with 50μg vaccine as part of the initial regimen in subjects aged six to under 12 years was linked to non-inferior anti-SARS-CoV-2 neutralising antibody responses as against people aged 18 to 25 years in the Phase III Cove trial.
Furthermore, a geometric mean ratio (GMR) of 1.5 was observed on comparing the response in children to those in young adults while the seroresponse rate was reported to be 99.3%.
Two 50μg doses of vaccine were found to be well tolerated.
In August last year, the vaccine obtained provisional registration from the TGA for active immunisation to prevent Covid-19 in people aged 18 years and above.
The regulatory authority expanded the registration in September to include people aged 12 years and above.
Moderna CEO Stéphane Bancel said: “The TGA authorisation for the use of our Covid-19 vaccine in children six-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorisation for the use of our vaccine in this age group.
“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.”
The latest move comes after the US Food and Drug Administration (FDA) approved the Biologics License Application for Moderna’s Covid-19 vaccine for usage in individuals aged 18 years and older.