The Therapeutic Goods Administration (TGA) has granted provisional determination to Moderna Australia Pty Ltd in relation to its COVID-19 vaccine, SPIKEVAX.

SPIKEVAX is provisionally approved for use in individuals 12 years of age or older. The granting of this determination means that Moderna Australia Pty Ltd is eligible to apply to vary the provisional approval for the vaccine for use in younger children.

Moderna’s COVID-19 vaccine (SPIKEVAX) – provisional determination granted for proposed use in children and booster shot for adults under evaluation