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 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.

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 6000 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”.

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.

– AAP

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