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Babies and young children aged six-months to five are now one step closer to receiving a COVID-19 vaccine after the national medical regulator gave the Moderna paediatric vaccine the green light.
- Moderna's paediatric dose is less concentrated than its adult COVID-19 vaccine
- ATAGI will now offer advice to the government about rolling out the Moderna vaccine to children
- The TGA provisionally approved Pfizer's COVID-19 vaccine for children last month
The Therapeutic Goods Administration (TGA) has provisionally approved a paediatric dose of the vaccine, which contains a lower concentration of the active ingredient.
Until now, the Moderna vaccine - known as Spikevax - had only been approved for people older than six years.
The TGA is recommending the vaccine be administered as two doses, at least 28 days apart.
The move follows the TGA's decision to provisionally approve Pfizer's COVID-19 vaccine for children in the same age group last month, and also comes after the US Food and Drug Administration authorised two different vaccines for children aged five and under.
However, the national advisory group's decision does not guarantee the vaccines will be rolled out to babies and young children, with the federal government now waiting on advice from the Australian Technical Advisory Group on Immunisation (ATAGI).
Australian Medical Association vice president Chris Moy said ATAGI would decide exactly who — if anyone — in the age group should receive the shots, and when.
"We still have to wait for ATAGI, which is the specialist advisor, to determine whether it's best used for all children in that age group or whether it's a situation where it would be targeted," Dr Moy said.
"Generally in that group, COVID tends to be milder and the risk of severe disease is less.
"It will be a question now — particularly with the BA.4/5 variants — how it's going to be best applied and which groups will be eligible in the coming weeks."
In a statement, the TGA said it made its decision by carefully considering data from a trial in the US and Canada, which included over 6,000 participants aged six months up to six years old.
"The study demonstrated that the immune response to the vaccine in children was similar to that seen in young adults (18-25 years) with a favourable safety profile," it said.
"Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard."