Novavax has received expanded approval for provisional registration from the Australian Therapeutic Goods Agency (TGA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years.
Nuvaxovid is indicated for active immunisation for the prevention of Covid-19 in individuals of this age group.
It is the first protein-based vaccine to be offered in Australia for adolescents aged 12 to 17 years.
The approval is based on findings from the paediatric expansion of the Phase III PREVENT-19 clinical trial of 2,247 adolescents of this age group at 73 sites in the US.
According to the findings, Nuvaxovid met the trial’s primary immunogenicity endpoint and showed overall clinical efficacy of 80% when the Delta variant was dominant in the US.
The vaccine was found to be well-tolerated as per initial safety data from the trial.
In January, the TGA granted provisional registration for vaccine usage in adults aged 18 years and above. It also received approval for heterologous and homologous boosting in June.
Biocelect is the sponsor of Novavax in Australia.
The vaccine is made from the genetic sequence of the SARS-CoV-2 virus’ initial strain and is formulated with the company’s saponin-based Matrix-M adjuvant.
Novavax president and CEO Stanley Erck said: “The provisional registration of Nuvaxovid for adolescents is timely with Australia’s current winter surge of Covid-19 and the return to schools.
“We are committed to reducing the burden of Covid-19 and believe that our vaccine, developed using an innovative approach to traditional technology, may help increase the adolescent vaccination rate.”
During this month, the US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) for Novavax’s Covid-19 vaccine.