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US-based Novavax has announced that New Zealand (NZ)'s Medsafe has granted expanded provisional approval for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent COVID-19 as a heterologous and homologous booster dose in adults aged 18 and older.
Following the expanded provisional approval decision by Medsafe, New Zealand, people may now choose Nuvaxovid as their first and/or second COVID-19 booster dose(s) after completion of their primary series using any of the authorized COVID-19 vaccines.
The request for expanded provisional approval for the booster dose is supported by 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 a booster for adults, Nuvaxovid is also provisionally registered in Australia and approved in Japan, and is actively under review in other markets.
New Zealand previously granted provisional approval for Nuvaxovid in adults aged 18 and older in February 2022. Novavax' sponsor in Australia and New Zealand is Biocelect Pty. Ltd.