Australia grants provisional registration for Novavax Covid-19 vaccine
Drug Approval

Australia grants provisional registration for Novavax Covid-19 vaccine

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

  • By IPP Bureau | January 20, 2022

Novavax announced that Australia's Therapeutic Goods Administration (TGA) has granted approval for provisional registration of Novavax' Covid-19 vaccine, for active immunization to prevent coronavirus disease 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.

 

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