October 29, 2021 -- Novavax completed its rolling submission to the Therapeutic Goods Administration (TGA) for provisional approval of its COVID-19 vaccine candidate in Australia.
The company said it has completed the submission of all modules required by the TGA for the regulatory evaluation of its COVID-19 vaccine. This includes preclinical, clinical, chemistry, manufacturing and controls data.
Novavax recently filed for conditional marketing authorization in the U.K. It expects to complete additional regulatory filings in Europe, Canada, New Zealand, and for the World Health Organization. The company expects to submit data to the U.S. Food and Drug Administration by the end of the year.