Novavax submitted variations to expand Australian and New Zealand provisional approval of Nuvaxovid COVID-19 vaccine in Great Britain

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On May 6, 2022, 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.

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Source: Novavax
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