The Therapeutic Goods Administration (TGA) has granted approval for provisional registration of Nuvaxovid Covid-19 Vaccine (adjuvanted) for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
It is recommended that the vaccine is given in two doses administered three weeks apart.
Nuvaxovid is provisionally approved for primary vaccination only. Studies for use of Nuvaxovid as a booster dose and in paediatric patients are ongoing, so the vaccine does not have regulatory approval for these purposes at this stage.
The Novavax vaccine has received conditional marketing authorisation by the European Medicines Agency, and the World Health Organisation has issued an emergency use listing for the vaccine.
Nuvaxovid is a protein subunit vaccine. Protein vaccines use a non-infectious component found on the surface of the coronavirus and are manufactured in cells in a laboratory. After vaccination, immune cells recognise the vaccine protein as foreign and launch an immune response against it.
Australia has played a pivotal role in Novavax’ Phase 1 and Phase 2 clinical trials supporting the development of Nuvaxovid. Additionally, a booster trial for Nuvaxovid and a Phase 1/2 trial for a combination seasonal influenza and Covid-19 vaccine are currently underway in Australia. Overall, nearly 1,500 Australians have participated in Novavax Covid-19 and combination vaccine clinical trials.
“The grant of provisional registration of Nuvaxovid by the TGA reflects Novavax’ increasing momentum around the globe and represents the first-protein based Covid-19 vaccine authorised for use in Australia,” says Stanley Erck, President and Chief Executive Officer, Novavax.
“While the world continues to grapple with the ever-changing nature of the virus, we look forward to delivering our vaccine to the people of Australia. We would also like to extend our gratitude to the Australian clinical trial participants who contributed so significantly to the development of our vaccine,” say Mr Erck.
Provisional approval of this vaccine in Australia is subject to certain strict conditions, such as the requirement for Biocelect Pty Ltd (on behalf of Novavax Inc) to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
Novavax and the Australian government announced an advance purchase agreement for 51 million doses of Novavax’s Covid-19 vaccine in January 2021. The first shipment to Australia of the Novavax vaccine is expected in the coming month.
