Variations to expand Australian and New Zealand provisional approval of Nuvaxovid COVID-19 vaccine to adolescents aged 12 through 17 years.- Novavax
Novavax announced the submission of variations to the Australian Therapeutic Goods Agency (TGA) and Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, to expand the provisional approval of its Nuvaxovid (NVX-CoV2373) COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 years.
TGA previously granted provisional registration in individuals 18 years of age and older in January 2022. Medsafe previously granted provisional approval in individuals 18 years of age and older in February 2022. The vaccine is given as a primary vaccination in two doses administered 21 days apart.
The request for provisional authorization is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agencies. This submission includes clinical 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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