TGA (Australia) grants expended approval for Nuvaxovid to prevent COVID 19 caused by severe acute respiratory syndrome in adolescents
Novavax, Inc. announced the Australian Therapeutic Goods Agency (TGA) has granted expanded approval for provisional registration of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to adolescents aged 12 through 17
"Today's provisional registration of Nuvaxovid for adolescents is timely with Australia's current winter surge of COVID-19 and the return to schools," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "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."
The provisional registration was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase III trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid.
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