Children aged six to 11 years will soon be eligible for the Moderna COVID-19 vaccine, after the Therapeutic Goods Administration provisionally approved the Spikevax jab in the lower age group this week.
While the TGA has approved the use, final approval must be given by the national vaccine advisory body, known as ATAGI (Australian Technical Advisory Group on Immunisation).
Children aged 12 and older were previously approved to receive the vaccine in September 2021.
The TGA has recommended a lower dosage for the younger cohort, of 0.25ml. People aged 12 years and older are administered a 0.5ml dosage.
The TGA issued a statement that the approval is based on data from clinical trials in the United States and Canada, on more than 4,000 children.
The study found the immune response in the children was similar to that in older eligible age groups.
The clinical trials found most side-effects in children were short-term and included pain at injection site, redness or swelling, fatigue, headaches, fever and muscular pain.
"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 full course of vaccination would include two doses of 0.25ml, administered at least 28 days apart — the same frequency as for other age groups receiving the Moderna vaccine.
Moderna is now the second vaccine available to children under 12, after Pfizer was approved for use in children five and up late last year.
There were widespread issues when children were added to the rollout in early January, with some parents saying they had to drive hundreds of kilometres to find appointments.
People had their appointments cancelled by GPs, with surgeries saying they had not received the doses needed by the federal government.
The approval from the TGA to Moderna is valid for two years.
