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.
"Today's provisional registration for Nuvaxovid as a booster in Australia is an important step in ensuring broad global access to diversified vaccine options," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "As COVID-19 continues to persist and evolve, we are pleased to be able to offer the first protein-based COVID-19 vaccine registered for use as both a primary series and now booster regardless of previous vaccine history."
The provisional registration was based on data from Novavax' Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 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 3 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. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, reflecting the increased immunogenicity seen with a third dose. Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.
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. Authorization in the U.S. The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. and the trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration.
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