Novavax Inc. said it completed its rolling submission for provisional approval of its Covid-19 vaccine candidate in Australia.
Novavax said it completed the submission of all modules required by the Therapeutic Goods Administration for the regulatory evaluation of its Covid-19 vaccine. This includes preclinical, clinical, and chemistry, manufacturing and controls data.
Novavax recently filed for conditional marketing authorization in the U.K. and expects to shortly complete additional regulatory filings in markets including Europe, Canada, New Zealand and for the World Health Organization. In the U.S., Novavax said it expects to submit the complete package to the Food and Drug Administration by the end of the year.
The submission in Australia was facilitated by the company's local partner, Biocelect Pty. Ltd., as sponsor.
Additional booster trials and a Phase 1/2 trial for a combination vaccine using Novavax's seasonal influenza and Covid-19 vaccine are underway in Australia, the company said.
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