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Novavax seeks approval in Australia as Indonesia gives green light
Novavax has completed it’s application to the Australian Therapeutic Goods Administration for provisional approval.
If successful, the vaccine would be the fourth approved jab in Australia, after AstraZeneca, Pfizer and Moderna.
It would also become the first protein-based vaccination eligible for use within the country.
Novavax, also announced they’ve recently filed for authorisation with the UK’s Medicines and Healthcare products Regulatory Agency, while the jab has been approved for emergency use within Indonesia.
“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 authorisation in the UK, brings us one step closer to our goal of ensuring broad global access to our vaccine,”
Novavax President and CEO Stanley C. Erck said in a statement.
The Novavax vaccine works as a two-dose jab, administered 21 days apart.
The vaccine is stored at 2C – 8C, which means existing cold chain channels can be used for the vaccine supply.
How effective is the Novavax jab in comparison to others?
According to the company’s clinical trial of 15,000 participants in Britain, the vaccine showed a 96.4 per cent efficacy against the original virus strain.
It also displayed 86.3 per cent effectiveness against the Alpha variant and 89.7 per cent efficacy overall.
While the biotech company claims a pivotal Phase 3 trial of 30,000 participants in the United States and Mexico showed a 100 per cent protection against moderate and severe disease, with a 90.4 per cent efficacy overall.
However, the company could not provide statistics against the current dominant Delta variant.