Nuvaxovid a COVID-19 vaccine is provisionally registered in Australia as a booster in individuals aged 18 and over.
Novavax, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has granted provisional registration of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over.
The provisional registration was based on data from Novavax' Phase II trial conducted in Australia, from a separate Phase II trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase II trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase III clinical trials. In the COV-BOOST trial, Nuvaxovid induced a robust antibody response when used as a heterologous third booster dose. In the Novavax-sponsored trials, following the booster, local and systemic reactions were generally short-lived with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low.
The TGA granted provisional registration in January 2022 for use of Nuvaxovid in individuals aged 18 and over. Novavax filed for expanded provisional registration in Australia for use in adolescents aged 12 through 17 in May 2022. Novavax' sponsor in Australia is Biocelect Pty. Ltd.
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