The Therapeutic Goods Administration has provisionally approved Moderna’s vaccine for children aged six months to five years.
Two paediatric doses of the vaccine – which contain a lower concentration of the active ingredient – have been recommended at least 28 days apart.
The federal government will now wait on advice from ATAGI before rolling out the vaccines.
“Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard,” the TGA said in a statement.
“The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.”
The TGA said the decision was based on clinical trials in the US and Canada, which included 6000 participants.
