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Australia Grants Provisional Approval For Novavax COVID-19 Vaccine

Novavax Inc. (NVAX) said that Australia's Therapeutic Goods Administration or TGA has granted approval for provisional registration of NVX-CoV2373, Novavax' COVID-19 vaccine (adjuvanted), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine will be supplied to Australia under the brand name Nuvaxovid.

Nuvaxovid is the first protein-based COVID-19 vaccine to receive approval for provisional registration in Australia.

The brand name Nuvaxovid has not yet been authorized for use in the U.S. by the FDA. Novavax' sponsor in Australia is Biocelect Pty. Ltd.

Novavax and the Commonwealth of Australia announced an advance purchase agreement for 51 million doses of Novavax' COVID-19 vaccine in January 2021, with the option for an additional 10 million doses.

Novavax received conditional marketing authorization for NVX-CoV2373 in the European Union and emergency use listing (EUL) from the World Health Organization (WHO). The Novavax/SII vaccine (brand name, Covovax) recently received emergency use authorization in India, Indonesia and the Philippines, as well as EUL from the WHO.

The Novavax/SK bioscience vaccine was granted approval in South Korea by the Ministry of Food and Drug Safety. The vaccine is also currently under review by multiple regulatory agencies worldwide.

The company submitted its complete chemistry, manufacturing and controls data package to the U.S. Food and Drug Administration at the end of 2021 and expects to submit a request for EUA for the vaccine in the U.S. after one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.

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