Moderna submits application to vaccinate 6 to 11 year-olds, join booster fight after TGA decision

The Therapeutic Goods Administration has revealed Moderna had become the second mRNA vaccine, after Pfizer, to apply for provisional approval in the age range.

The company has also submitted a separate application for the jab to be used in the national booster rollout which began earlier this month.

The vaccine was currently approved for children aged 12 and over, having been given the green light in September. But the TGA on Wednesday allowed Moderna to submit its data on younger children.

"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," its statement read.

"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."

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The regulator said it had also taken into account the health threat COVID-19 posed to young children, along with its impact on participation in school and sporting activities.

The TGA has also been considering an application from Pfizer to vaccinate children aged under 12, with Health Minister Greg Hunt in October saying the process would be expedited.

Moderna required at least a month between doses, with protection taking up to two weeks to kick in.

If granted approval, it would become the second vaccine used as a booster in Australia.

Pfizer was currently being administered as a third dose to Australians aged 18 and over, regardless of which vaccine they originally received.

Immunocompromised Australians have been eligible for boosters since October, and the program was expanded to the broader population this month.

By Tuesday, more than 206,000 Australians had received a third dose.

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