Australian infants are a step closer to receiving Moderna's COVID-19 vaccine, but the Health Minister is warning supply constraints mean parents will not be able to make bookings in the short-term.
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The Therapeutic Goods Administration on Tuesday revealed it had granted the Moderna jab, currently only available to those aged six or over, provisional approval for children aged between six months and six years-old.
But Health Minister Mark Butler has stressed the development is "just the first step" in making vaccines available to infants, warning "very limited" Moderna supply globally will prove a stumbling block.
The federal government was now awaiting advice from the Australian Technical Advisory Group on Immunisation on whether to roll out the vaccine to that age range.
The TGA said its decision was based on clinical trials in the US and Canada, showing "the safety profile in children is similar to that seen in adults" - including protection against severe COVID-19 symptoms, hospitalisation, and death.
"Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard," it said.
Mr Butler insisted the federal government was in negotiations with Moderna to secure additional doses, despite "fierce competition" for its finite supply.
But he stressed ATAGI was yet to approve infant vaccines, which would also likely be constrained by "very limited" Moderna supply globally.
"Until that point, this is simply not a vaccine that would be available to those children. Also, if ATAGI does approve that vaccine to children of that group ... then supply of that vaccine also needs still to be arranged," he said.
"I want to stress that in spite of this good news ... there is no action yet that can be taken by parents or should be taken to seek to make an appointment or otherwise."
As with previously eligible cohorts, young children will receive two doses of the jab spaced at least 28 days apart, though they will contain a lower concentration of the active ingredient.
The agency said adverse events reported during the trials were typically mild to moderate, and reported after the second dose. They mainly included crying or irritability, fatigue, fever and muscle pain.
"The TGA will continue to actively monitor the safety of the vaccine in children and adults both in Australia and through collaboration with our overseas counterparts," the TGA said.
"If safety concerns are identified, we will take action and promptly provide information to the public."
The approval was valid for two years, and the TGA will require Moderna to provide updated data on its efficacy.
'Great news'
Victoria Woolley was relieved COVID-19 vaccinations were one step closer for her seven-month-old, Henry Roohan.
"It's great news. We thought it would take a lot longer, so it's exciting to be able to do something to protect little Henry and feel like you're not risking his health every time you go out," Ms Woolley said.
"We've had a few colds and flus and, amazingly, no COVID for the family. [We're] hearing lots of people we know, lots of mum friends and their little bubs have had COVID ... and they've all bounced back.
"But you just don't want to be that one case where it's not okay."
Recently arriving home from the United States, Treena Pritchard and her 11 month-old daughter Sofia Pritchard were unable to dodge the virus, both catching COVID-19 overseas.
"We got it and it was scary because she had a fever for maybe two days and she was cranky for about a week," she said.
Ms Pritchard said they planned to wait the three month period after having COVID-19, and were relieved Sofia would likely soon be eligible.
"We were going to get it done in the US, but COVID ended up getting all of us ... She'll still get [the vaccination] and it won't be as scary as it was," she said.