In order to meet the varied demands of the public, Australia’s COVID-19 immunization approach has been characterized by flexibility and inclusivity, utilizing a variety of vaccine technologies. As the first protein-based COVID-19 vaccine authorized in the nation, Novavax’s NuvaxovidTM (NVX-CoV2373) stands out among them and provides a substitute for individuals who are wary about mRNA vaccinations.
Regulatory Approval and Deployment
On January 19, 2022, the Therapeutic Goods Administration (TGA) granted provisional approval to Nuvaxovid for individuals aged 18 and over, following rigorous evaluation of its safety, quality, and efficacy. This approval was based on data from extensive clinical trials demonstrating approximately 90% efficacy in preventing symptomatic COVID-19. Novavax Investor Relations | Novavax+3Therapeutic Goods Administration (TGA)+3Therapeutic Goods Administration (TGA)+3
Subsequently, on July 25, 2022, the TGA extended this provisional approval to adolescents aged 12 through 17, making Nuvaxovid the first protein-based COVID-19 vaccine available for this age group in Australia. Health.gov.au+7Novavax Investor Relations | Novavax+7Therapeutic Goods Administration (TGA)+7
Vaccine Technology and Composition
Nuvaxovid employs a recombinant protein-based nanoparticle technology, presenting the SARS-CoV-2 spike protein to the immune system without using live virus. This approach is enhanced by the Matrix-M™ adjuvant, derived from the bark of the Quillaja saponaria tree, which boosts the body’s immune response. Health.gov.au+3Novavax+3Novavax Investor Relations | Novavax+3
Each 0.5 mL dose contains 5 micrograms of the spike protein and 50 micrograms of the Matrix-M adjuvant. The vaccine is administered in a two-dose schedule, with doses given three weeks apart. Health.gov.auHealth.gov.au+2Therapeutic Goods Administration (TGA)+2Health.gov.au+2
Safety and Efficacy
Clinical trials involving over 45,000 participants have demonstrated Nuvaxovid’s high efficacy and favorable safety profile. Common side effects include injection site tenderness, headache, fatigue, and muscle pain, typically resolving within a couple of days. Therapeutic Goods Administration (TGA)+6Health.gov.au+6Novavax Investor Relations | Novavax+6Novavax Investor Relations | Novavax+1Health.gov.au+1
Serious adverse events were rare. While a few cases of myocarditis were reported, the incidence was low and comparable to placebo groups, making it difficult to establish a causal relationship. Health.gov.au
Booster Dose Approval
Recognizing the need for booster doses to maintain immunity, the TGA provisionally approved Nuvaxovid as a booster for individuals aged 18 and over on June 13, 2022. This approval was based on data from multiple Phase 2 trials, including studies conducted in Australia, South Africa, and the UK. Therapeutic Goods Administration (TGA)+4Novavax Investor Relations | Novavax+4Therapeutic Goods Administration (TGA)+4
The Australian Technical Advisory Group on Immunisation (ATAGI) recommends Nuvaxovid as a booster option, particularly for individuals who cannot receive mRNA vaccines. Health.gov.au+1Health.gov.au+1
Supply and Distribution
To ensure adequate supply, the Australian government finalized an advance purchase agreement with Novavax for 51 million doses of Nuvaxovid in January 2021. The vaccine is distributed in Australia by Biocelect Pty Ltd, Novavax’s local partner.