On Thursday, Australia’s drug regulator, the Therapeutic Goods Administration (TGA), the COVID-19 vaccine from U.S. maker Novavax, making Australia’s TGA one in a growing list of major regulators to approve the long-delayed COVID-19 vaccine.
“We know that some people have waited for this vaccine, and … hopefully this will encourage those people in the last 5% [of unvaccinated people] to come forward,” Australian Health Minister Greg Hunt told reporters on Thursday. Australia has ordered 51 million Novavax doses and expects to receive the first shipment this month, he said.
Australia’s government reports that as of Thursday over 95% of its population above the age of 16 has gotten at least one dose of a COVID-19 vaccine, while 92.8% of the population has been fully vaccinated.
Novavax’s stock price dropped 6.2% on Wednesday in New York. But after Australia announced its Novavax approval, shares rebounded 1.5% in after-hours trading.
Novavax’s COVID-19 vaccine, which goes by the brand name Nuvaxovid, still has one final regulatory hurdle to clear—a review from the Australian Technical Advisory Group on Immunisation—but government officials expect to roll out the jab to the Australian public within weeks. For now, Australia will offer Novavax’s jab in two-dose regimens for people over age 18 who have not yet been vaccinated. The TGA said that it is waiting for more data to approve the vaccine as an option for a booster dose as well as for people below the age of 18.
John Skerritt, head of the TGA, said in a press conference that there has been strong public interest in the vaccine because it relies on older technology than mRNA jabs from makers Pfizer and Moderna. Novavax’s jab is a protein-based, subunit vaccine that teaches the immune system to make antibodies to fight off COVID-19 using a technology similar to vaccines used against disease like Hepatitis B.
“I have [received] several hundred emails from individuals and groups who have said for whatever reason we would like to have [this] particular vaccine … this just gives them further choice,” Skerritt said.
Australia’s Novavax approval adds a fourth jab to the country’s vaccination drive, following approvals of mRNA shots from Moderna and Pfizer as well as the one-shot, viral vector jab from Johnson & Johnson.
Novavax initially released clinical results of its vaccine, which demonstrated up to 96% efficacy in preventing COVID-19 infections, in March 2021. But the company struggled through months of manufacturing and regulatory delays in 2021. Indonesia became the first country to approve the drug last November.
Novavax says it will officially file its emergency use application to U.S. regulators by the end of January, and CEO Stanley Erck recently told CNBC he is hopeful that the U.S. will approve the vaccine by early April, at the latest.
Novavax has been gaining wider global acceptance in recent weeks, winning approvals from the World Health Organization, the European Commission, South Korea, India, and the Philippines in recent months.
“The grant of provisional registration of Nuvaxovid by the TGA reflects Novavax’ increasing momentum around the globe,” Erck said in a press release about the drug’s approval in Australia. “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.”
