Biotech & Health

Montgomery County-based Novavax Wins Approval for Its COVID-19 Vaccine from Australian Government

MBS Staff

Gaithersburg-based Novavax (NASDAQ: NVAX) finally received approval from Australia's Therapeutic Goods Administration — an equivalent to the U.S. Food and Drug Administration (FDA) — to distribute its COVID-19 vaccine marketed as Nuvaxovid to the Countries population.

It’s one of the most pivotal and anticipated approvals for Novavax. The Commonwealth of Australia played a key role in developing NVX-CoV2373 (the scientific name Nuvaxovid) with clinical trials in Phase 1 and Phase 2 happening there.

Furthermore, a Phase 1/2 trial for a COVID-19 and seasonal influenza combination vaccine is happening in Australia as well. Almost 1,500 Australians have participated in all clinical trials.

The Novavax vaccine has also shown greater efficacy against competitors when tested against the Omicron variant.

"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."

Novavax is still waiting for approval from the FDA, but it has already received permission from several countries including South Korea, India, Indonesia, Philippines, and the largest from the European Union and from the World Health Organization (WHO).