Moderna takes step towards under-12s jab
The TGA has granted a "provisional determination" to Moderna's SPIKEVAX. Photo: AAP
Health authorities have taken a step towards approving a COVID-19 vaccine for children aged six to 12.
The Therapeutic Goods Administration on Wednesday granted a “provisional determination” to Moderna Australia in relation to its COVID-19 vaccine, SPIKEVAX.
Currently, SPIKEVAX is provisionally approved for use in individuals 12 years of age or older.
The granting of the determination means Moderna can apply to vary the provisional approval for the vaccine for use in children aged under 12.
In making its decision, the TGA considered evidence of a plan to submit comprehensive clinical data in relation to use in children, the regulator said in a statement.
The TGA also considered infections in children and the impacts of COVID-19 in relation to children’s participation in school and sporting activities.
“Moderna Australia has now submitted data for provisional approval and the TGA is assessing the use of SPIKEVAX in children six to 11 years old,” it said.
Moderna has also submitted an application to the TGA in relation to the use of SPIKEVAX as a booster dose.
The move comes after TGA chief Professor John Skerritt said recently he expected vaccines for kids could begin later this year.
However, Prime Minister Scott Morrison has also said Australia wouldn’t begin those jabs until the TGA and the Technical Advisory Group on Immunisation (ATAGI) both approved, saying the regulators “have not yet formed a medical opinion that that should proceed at this point”.
“We need to be very careful. We need to be very cautious,” the PM said in Newcastle on Monday.