Novavax has concluded the rolling submission to the Australian Therapeutic Goods Administration (TGA) seeking provisional approval for its Covid-19 vaccine candidate, NVX-CoV2373.
The company submitted all TGA-required modules to carry out the regulatory review of the vaccine.
Preclinical, clinical, chemistry, manufacturing and controls data are included in the submission.
The recombinant nanoparticle protein-based vaccine was made using the genetic sequence of the initial SARS-CoV-2 strain. It has Matrix-M adjuvant to boost immune response and induce greater neutralising antibody levels.
The Phase I and Phase II clinical trials of the vaccine were conducted in the country with further booster trials and a Phase I/II trial for a combination vaccine progressing.
These trials will evaluate a combination shot that uses the company’s seasonal influenza and Covid-19 vaccine.
A Phase III trial that enrolled 15,000 subjects in the UK showed that NVX-CoV2373 was found to have 96.4% efficacy against the original SARS-CoV-2 strain.
Furthermore, the vaccine demonstrated an efficiency of 86.3% against the Alpha variant and overall efficacy of 89.7% with an encouraging safety and tolerability profile.
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