TGA (Australia)grants provisional approval for Moderna’s COVID-19 vaccine in children aged six months to five years.
Moderna, Inc. announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 25 µg per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years.
Until now, children under six were the only age group not eligible for vaccination against COVID-19 in Australia.
Positive interim results from the Phase II/III KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile.
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