TGA grants provisional determination for Moderna jab for children under 12

The TGA has announced one vaccine brand could soon be given to Aussie children aged 6 - 11.

Children as young as six could soon receive the Moderna jab as the Therapeutic Goods Administration announces the vaccine brand has been granted provisional determination.

If approved, SPIKEVAX (commonly known by the name of its manufacturer, Moderna) could become the first vaccine in Australia available to children under 12.

The TGA said the decision was based on updated clinical data on the use of the vaccine in children, as well as the impacts Covid-19 was having on children’s schooling.

“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,” a statement from the health authority reads.

“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.”

The TGA has granted provisional determination to Moderna for use of it’s vaccine in children aged 6-11 years old. Picture: Joseph Prezioso / AFP

The TGA’s announcement follows some very different announcements from other nations about the use of Moderna in children.

France and Sweden have announced further restrictions on the use of Moderna in young people, revoking their recommendation of the vaccine for people aged under 30.

Both governments cited comparatively higher risks of heart-related problems in young people from the Moderna vaccine as their reason for the decision.

France and Sweden have announced further restrictions on the use of Moderna in young people, revoking their recommendation of the vaccine for people aged under 30. Picture: Frederic J. BROWN / AFP

The Pfizer vaccine was also granted provisional determination for under 12s by the TGA last month, and looks set to be granted full approval ahead of Moderna.

“The TGA has received their advice from Pfizer, in terms of an application for that age group, and they are going through that process,” Chief Medical Officer Paul Kelly said.

“That‘s a really important factor that will come through in the coming weeks and by the end of the year.”

If the Moderna vaccine is approved by the TGA, children in grades 1-6 should all become eligible for the vaccine. Picture: NCA NewsWire / Christian Gilles

Aussie children have been particularly hard hit by the most recent wave of Covid-19. Transmission of the virus has been commonplace in primary schools where most of the student population is under 12 and therefore ineligible for any Covid-19 vaccine.

If Moderna is approved by the TGA, children in grades 1 - 6 should all become eligible for the vaccine.