Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Australia's Therapeutic Goods Administration (TGA) has granted approval for provisional  registration of NVX-CoV2373, Novavax' COVID-19 vaccine (adjuvanted), for active immunization to prevent coronavirus disease 2019 (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™.

"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 authorized for use in Australia," said Stanley C. 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."

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 approval for provisional registration by the TGA is based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19 enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with almost 15,000 participants in the U.K., the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

Novavax and the Commonwealth of Australia announced an advance purchase agreement (APA) for 51 million doses of Novavax' COVID-19 vaccine in January 2021, with the option for an additional 10 million doses (up to 61 million doses total). The approval for provisional registration leverages Novavax' manufacturing partnership with Serum Institute of India (SII), the world's largest vaccine manufacturer by volume, which will supply initial doses to Australia. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.

Novavax received conditional marketing authorization (CMA) 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 (EUA) 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 (MFDS). The vaccine is also currently under review by multiple regulatory agencies worldwide. The company submitted its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) 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.

For more information on Nuvaxovid, including the Australian approved Product Information, Australian approved Consumer Medicines Information and Important Safety Information, or to request additional information please visit the following websites:

• Novavax global authorization website
• TGA vaccines website

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. 

Provisional Registration of Nuvaxovid^™ in Australia

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. 

Important Safety Information

• Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
• Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid.
• Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress–related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
• Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection.
• Nuvaxovid should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
• The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.
• Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
• The effects with Nuvaxovid may temporarily affect the ability to drive or use machines.
• Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients.
• The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

For additional safety information, please visit www.NovavaxCovidVaccine.com for the full Australian Product Information (PI) and Australian Consumer Medicine Information (CMI). Information regarding adverse event reporting instructions can also be found at www.NovavaxCovidVaccine.com.

Information on this vaccine is also available on the Australia Therapeutic Goods Administration website: www.tga.gov.au.