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Australia Drug Approvals | Drugs approved by TGA

Updated: Oct 13, 2022

September 30, 2022

TGA approved Moderna bivalent vaccine as a booster dose.

The Therapeutic Good Administration granted provisional approval for Moderna's bivalent COVID-19 vaccine as a booster dose. The bivalent vaccine contains original and Omicron BA.4/BA.5 strains and stimulates immunization against the original and Omicron variant.

Moderna can now submit for provisional registration of bivalent vaccine. The company has six months to submit a registration application. Moderna has to offer the clinical trial results for the vaccine's approval.

Previously, Moderna has received provisional approval in Australia for a bivalent vaccine comprising mRNA for the original virus and Omicron BA.1 strain. TGA announced that the bivalent vaccine stimulated a higher immune response against BA.4 and BA.5 variants than the initial Spikevax vaccine.


Feb 23, 2022

Moderna's Spikevax received provisional approval for individuals aged six years and older

The Therapeutic Goods Administration (TGA) in Australia has given provisional approval for Spikevax for individuals aged six years and older. Spikevax is Moderna's COVID 19 vaccine.

TGA has granted provisional approval previously for children aged six to eleven years. The provisional approval is based on the KidCOVE clinical trials, which included 4,000 participants in Canada and the USA. The vaccine demonstrated a similar immune response in children as that in adults.

The Australian Technical Advisory Group on Immunisation (ATAGI) will advise the Government on using the vaccine in the age group.

Jan 28, 2022

Comirnaty received provisional approval in Australia as a booster in 16-17 years old individuals.

The Therapeutic Goods Administration (TGA) has given provisional approval to Comirnaty as a booster dose for individuals aged 16-17 years. Earlier, TGA has given provisional approval as a booster shot for individuals 18 years and older.

The dosage is the same as for adults and should be administered after the two primary doses. Comirnaty received approval as a booster dose in the same age group in the UK, the US, and Israel.