The Therapeutic Goods Administration (TGA) has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine for use in children aged six months to five years.
Currently this mRNA vaccine is provisionally approved for immunisation to prevent COVID-19 in individuals aged six years and older (primary series of two doses administered at least 28 days apart), and as a booster dose for adults aged 18 years and older. The paediatric vaccine is made in the same way as the vaccines for older persons, however it contains a lower concentration of the active ingredient.
Importantly, TGA provisional approval is the first step in consideration of the use of a COVID-19 vaccine in Australia. This decision indicates the vaccine has met high safety, quality and efficacy standards.
The potential use of this vaccine in the national COVID-19 vaccination program, including use in which, if any, children in this age group is still to be determined. As with all COVID-19 vaccines, the Australian Technical Advisory Group on Immunisation (ATAGI) will provide advice to the Federal Government on these matters in the coming weeks.