Biotechnology company Novavax Inc (Nasdaq:NVAX) reported on Wednesday the receipt of approval from Australia's Therapeutic Goods Administration (TGA) for provisional registration of its COVID-19 vaccine (adjuvanted), NVX-CoV2373.

The vaccine will be supplied to Australia under the brand name Nuvaxovid. The vaccine will be used for the active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older.

This TGA approval for provisional registration is based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes the company's two pivotal Phase 3 clinical trials. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile. Australia has played a pivotal role in Novavax' Phase 1 and Phase 2 clinical trials.

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.

Under an advance purchase agreement (APA) with the Commonwealth of Australia, the company signed for 51m doses of Novavax' COVID-19 vaccine in January 2021, with the option for an additional 10m doses (up to 61m doses total). The approval for provisional registration leverages Novavax' manufacturing partnership with Serum Institute of India (SII), which will supply initial doses to Australia.