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TGA approves provisional determination for Biocelect Pty Ltd for COVID-19 vaccine, Nuvaxovid

10 March 2022

The Therapeutic Goods Administration (TGA), part of the Department of Health, has granted a second provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to its COVID-19 vaccine, Nuvaxovid.

Currently, Nuvaxovid is provisionally approved for the active immunisation of adults aged 18 years and older for the prevention of disease caused by SARS-CoV-2.

The new provisional determination means that Biocelect Pty Ltd (on behalf of Novavax Inc.) is now able to apply for provisional registration for the Novavax COVID-19 vaccine for use in adolescents and children as data becomes available. Biocelect Pty Ltd has indicated that they intend to apply for provisional registration of the vaccine for use in individuals 12 years and older in April 2022 and anticipate that an application for use in children 5-11 years old will be submitted to the TGA later in the year.

In making its decision to grant Biocelect Pty Ltd a provisional determination, the TGA considered evidence of a plan to submit comprehensive clinical data in relation to use in children and adolescents as it becomes available.

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