The Therapeutic Goods Administration (TGA), part of the Department of Health, has granted a provisional determination to Moderna Australia Pty Ltd in relation to its COVID-19 vaccine, SPIKEVAX.
Currently, 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.
In making its decision to grant Moderna a provisional determination, the TGA considered evidence of a plan to submit comprehensive clinical data in relation to use in children. The TGA also considered infections in children and the impacts of COVID-19 in relation to children’s participation in school and sporting activities.
Moderna Australia has now submitted data for provisional approval and the TGA is assessing the use of SPIKEVAX in children 6 to 11 years old.
Moderna has also submitted an application to the TGA in relation to the use of SPIKEVAX as a booster dose and this is under evaluation.
