TGA provisionally approves Moderna Covid vaccine for use in children from 6 months

TGA

The Therapeutic Goods Administration (TGA) has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 months to less than 6 years (6 months to 5 years).

Currently this mRNA vaccine is provisionally approved for immunisation to prevent COVID-19 in individuals aged 6 years and older (primary series of 2 doses administered at least 28 days apart), and as a booster dose for adults aged 18 years and older. 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 hospitalization and death.

As with other age groups, the use of this vaccine in children from 6 months should be administered as 2 doses at least 28 days apart. 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:

  • 6 months to less than 6 years (6 months to 5 years) – 25 micrograms in 0.25ml vial
  • 6 to 11 years – 50 micrograms in 0.25ml vial
  • 12 years and older – 100 micrograms in 0.5ml vial
/Public Release. View in full here.