By Teddy Cambosa
Biotechnology company Novavax has announced that it has already completed its rolling submission to the Therapeutic Goods Administration (TGA) in Australia for provisional approval of its COVID-19 vaccine candidate.
The company’s application to the TGA marks the first complete application for provisional approval of a protein-based COVID-19 vaccine in Australia.
Novavax recently filed for conditional marketing authorization in the U.K. and expects to shortly complete additional regulatory filings in key markets, including Europe, Canada, New Zealand and the World Health Organization, as well as other markets around the world. In the U.S., Novavax expects to submit the complete package to the FDA by the end of the year.
“This submission brings Novavax significantly closer to delivering doses of the first protein-based COVID-19 vaccine to Australia and, along with this week’s filing for conditional marketing authorization in the U.K., brings us one step closer to our goal of ensuring broad global access to our vaccine,” said Stanley C. Erck, President and Chief Executive Officer, Novavax.
He added, “We thank the Australian clinical trial participants and trial sites, as well as the regulatory and vaccine experts, for their assistance and contribution to this vaccine program.”
Australia has played a pivotal role in the Phase 1 and Phase 2 clinical trials of Novavax in supporting the development of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant.
The latest clinical data from a pivotal Phase 3 trial of 15,000 participants in the U.K. was submitted to the TGA earlier this year in which NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall, as well as a favorable safety and tolerability profile.
Teddy Cambosa is a graduating BS Biology student and a former campus journalist at Batangas State University
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