The Moderna covid vaccine is now provisionally approved for children under six and awaits the ATAGI nod.
A covid-19 jab for babies as young as six months has passed the first hurdle to becoming available in Australia.
The TGA has green-lit Modernaâs mRNA vaccine, Spikevax, for children aged between six months and five years old.
It is the first covid vaccine to be okayed by the Australian regulator for this age group.
Last month, the TGA granted a provisional determination to Pfizer which allows the pharmaceutical giant to apply for approval of its covid vaccine, Comirnaty, for children aged six months to five years. This has not yet gained provisional approval.
As is the case for other age groups, a primary course of the vaccine will count as two doses delivered at least 28 days apart.
The paediatric vaccine has the same formulation as the regular Moderna jabs for older children and adults, just at a lower concentration.
Where people aged 12 and older receive 100 micrograms in a 0.5mL vial and children six to 11 years old receive 50 micrograms in a 0.25mL vial, children younger than six will receive 25 micrograms in a 0.25mL vial.
The decision on which, if any, children in this age group will receive the vaccine now passes to ATAGI, which is expected to provide a recommendation to the government over the coming weeks.
In making the provisional approval, the TGA considered data from a clinical trial in the US and Canada which followed 6000 babies and young children.
The trial found that the immune response to the weakened vaccine was similar to that of adults aged between 18 and 25 who received the original formulation, with a similar safety profile.
The most common adverse events for the six months to five years cohort included irritability, crying, redness or swelling at injection site, fatigue, fever, muscle pain and axillary swelling or tenderness in the groin.
This provisional approval comes about a month after the US Food and Drug Administration authorised the vaccine for use in the same group.
