Major problem with vaccine change for Australian babies

Australia’s medical regulator has made a major announcement about Covid-19 vaccines, but there is one significant issue.

Australia’s medical regulator has provisionally approved the use of Moderna’s Covid-19 vaccine for children aged under six.

The Therapeutic Goods Administration examined a North American clinical trial before making its decision on infants and children.

Its decision is a “first step” towards allowing the jab and “indicates that the vaccine has met high safety, quality and efficacy standards”, the TGA said.

It will now be up to the Australian Technical Advisory Group on Immunisation (ATAGI) to recommend to the government whether or not to proceed with vaccinating young children.

Moderna’s Covid-19 vaccine has passed its first hurdle towards being allowed for young children. Picture: NCA NewsWire / Dan Peled

Health Minister Mark Butler said sourcing enough doses of the vaccine would be another hurdle to overcome.

“As you can imagine, there is fierce competition by countries in North America, Europe and other parts of the world to get their hands on this very limited supply,” Mr Butler told reporters.

“I've reported before that my department is in active negotiations right now with Moderna for Australia to secure as many doses as we possibly can from this very limited global supply.”

Moderna’s product, called Spikevax, has until now only allowed for people aged over six to be vaccinated.

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

People over 18 can also get it as a booster.

After Tuesday’s announcement, children as young as six months could be able to get the vaccine.

Those under six years old will be recommended two Moderna doses.

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

The North American trial was conducted across several sites and involved 6000 participants aged between six months and six years old.

“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,” the TGA said.

“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 up to six were mild to 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,” the TGA said.

More to come.