Big vaccine change for Australian children aged under six

Australia’s medical regulator has made a major announcement about Covid-19 vaccines for the country’s youngest children.

Australia’s medical regulator has approved the use of Moderna’s coronavirus vaccine for children aged between six motnhs and five years. Picture: NCA NewsWire / David Geraghty

Australia‘s medical regulator has approved the use of Moderna’s coronavirus vaccine for children aged between six motnhs and five years.

The Therapeutic Goods Administration looked at a study from the US and Canada before making the decision the vaccine is safe for infants and young children, it said in a release on Tuesday.

Moderna’s product, called Spikevax, is currently only allowed for people aged six years and older.

Those people can get two doses of the vaccine, 28 days apart.

People over 18 can also get it as a booster.

The TGA said children under six were recommended two Moderna doses, to be given 28 apart.

The concentration of the vaccine’s active ingredient will be lower in doses given to small children.

“In making this regulatory decision, the TGA carefully considered data from the KidCOVE clinical trial, which was conducted at multiple sites throughout Canada and the United States and included over 6000 participants aged 6 months up to 6 years,” the TGA statement said.

“The study demonstrated that the immune response to the vaccine in children was similar to that seen in young adults (18 to 25 years) with a favourable safety profile.

“Clinical trials also showed that the safety profile in children is similar to that seen in adults. Most adverse events seen in clinical trials in children aged 6 months up to 6 years were mild-moderate and generally reported after the second dose.

“These included irritability/crying, redness and/or swelling at injection site, fatigue, fever, muscle pain and axillary (groin) swelling or tenderness.”

More to come.

Originally published as Big vaccine change for Australian children aged under six