Another COVID-19 vaccine given provisional approval for use in Australia

Australia’s pharmaceutical watchdog has provisionally approved another COVID-19 vaccine for use in Australia.

Novavax has today been given the greenlight by the Therapeutic Goods Administration, becoming the first protein COVID-19 vaccine to receive regulatory approval in the country.

According to the TGA, the vaccine is recommended to be given in two doses, administered three weeks apart.


At this stage, the jab has only been provisionally approved for primary vaccination in people aged over 18.

“Studies for use of Novavax as a booster dose and in paediatric patients are ongoing, so the vaccine does not have regulatory approval for these purposes at this stage,” the TGA said.

Novavax is a protein subunit vaccine, which uses a “non-infectious component found on the surface of the coronavirus and is manufactured in cells in a laboratory”.

“After vaccination, immune cells recognise the vaccine protein as foreign and launch an immune response against it,” the TGA said.

Therapeutic Goods Administration head Professor John Skerritt said he’s hopeful the TGA’s provisional approval of the vaccine will encourage previously hesitant Australians to roll up their sleeves.

“The technology on which it is made is an older technology, it uses a protein, so I would have had several hundred emails from individuals groups who have said for whatever reason we would like to have a particular vaccine,” Skerritt said.

“So I don’t know whether it is 50,000 or 100,000 or a million or whatever individuals, I don’t think anybody knows but there are some individuals, and this just gives them further choice.”

The Federal Government has secured 51 million doses of the Novavax jab, with the first shipment set to arrive in Australia in the coming month.

“Australians can be confident that the TGA’s review process of Novavax was rigorous,” the TGA said.

“The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with expertise in scientific, medical and clinical fields including consumer representation.”

It comes as the TGA also today announced it had given provisional approval to the use of two new oral treatments for COVID-19.

The medicines, made by Pfizer and Merck Sharp & Dohme, will be free and available via prescription.

The pills will largely be given to vulnerable people with the virus who are at increased risk of progression to hospitalisation or death.

“That is a really important addition in a very important sign of hope and protection for the Australian public,” Health Minister Greg Hunt said.