Key Points
- The Therapeutic Goods Administration (TGA) has provisionally approved the Moderna vaccine for children aged six months to six years old.
- It is the first time a vaccine for the age group has received provisional approval in Australia.
Australian babies and young children could soon be eligible for protection from COVID-19 after the medicines regulator provisionally approved a vaccine.
The Therapeutic Goods Administration (TGA) has provisionally approved the Moderna vaccine for children aged six months to up to six years old.
It is the first time a vaccine for the age group has received provisional approval in Australia.
A paediatric dose of the vaccine, known as SPIKEVAX, would involve two shots, 28 days apart.
The TGA considered data from clinical trials in Canada and the United States, which included more than 6,000 participants aged from six months to six years.
The study found the immune response to the vaccine in children was similar to that seen in young adults aged 18 to 25 years and had similar safety levels.
In a statement, the regulator said provisional approval was the first step and the decision indicates "that the vaccine has met high safety, quality and efficacy standards".
"As we have seen with children in older age groups, the TGA expects that vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalisation and death," the statement said.
The approval lasts for two years, with Moderna required to continue providing information to the TGA on longer-term efficacy and safety from ongoing trials.
It comes weeks after that experts say will effectively curb the spike of cases across the country.
But vaccine rates have begun to plummet despite the federal government having bought around 255 million doses of various vaccine brands. Of those, only 60 million have been administered so far.
Australia's immunisation expert advisory group ATAGI will now assess the regulator's approval and provide advice to the government about whether children in the age group should be eligible.
