Therapeutic Goods Administration approves Moderna COVID-19 vaccine for young children

Babies and young children aged six-months to five are now one step closer to receiving a COVID-19 vaccine after the national medical regulator gave the Moderna paediatric vaccine the green light.

The Therapeutic Goods Administration (TGA) has provisionally approved a paediatric dose of the vaccine, which contains a lower concentration of the active ingredient. 

But Health Minister Mark Butler warned parents not to try to immediately book their children in for the vaccine, as it was not yet available.

“I want to stress in spite of this good news — the TGA has been able to approve this Moderna product for under five year olds — there is no action yet that can be taken by parents or should be taken to seek to make an appointment or otherwise,” he said.

“There are still a number of steps yet that need to be secured before we are in a position to make available this vaccine to parents and their very young children.”

Until now, the Moderna vaccine — known as Spikevax — had only been approved for people older than six years.

The TGA is recommending the vaccine be administered as two doses, at least 28 days apart. 

The move follows the US Food and Drug Administration authorised two different vaccines for children aged five and under.

However, the national advisory group’s decision does not guarantee the vaccines will be rolled out to babies and young children, with the federal government now waiting on advice from the Australian Technical Advisory Group on Immunisation (ATAGI).

Australian Medical Association vice president Chris Moy said ATAGI would decide exactly who — if anyone — in the age group should receive the shots, and when.

“We still have to wait for ATAGI, which is the specialist advisor, to determine whether it’s best used for all children in that age group or whether it’s a situation where it would be targeted,” Dr Moy said.

“Generally in that group, COVID tends to be milder and the risk of severe disease is less.

“It will be a question now — particularly with the BA.4/5 variants — how it’s going to be best applied and which groups will be eligible in the coming weeks.”

Mr Butler said that, even if ATAGI approved the vaccine for use among young children, supply was severely limited.

“There is very limited supply of this Moderna product, which is a different product to the products made available to other age cohorts … very limited supply of this Moderna product across the world and, 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.

“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. And those negotiations are continuing.”

In a statement, the TGA said it made its decision by carefully considering data from a trial in the US and Canada, which included over 6,000 participants aged six months up to six years old.

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

“Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard.”

Mark Butler and Paul Kelly stand at lecturns in Parliament House
Mark Butler and Paul Kelly have warned there’s been a significant increase in COVID-19 cases and pressure on hospitals.(ABC News: Matt Roberts)

Chief Medical Officer warns start of new Omicron wave

Chief Medical Officer Paul Kelly, who joined Mr Butler at his press conference, warned the nation is only at the beginning of the new Omicron wave.

Professor Kelly said the BA.4 and BA.5 sub-variants of the COVID-19 Omicron strain were highly infectious, and all indications suggested cases would continue to rise over the coming month.

“We’re at the start of this wave not the end — we know that’s associated with hospitalisations — but what happens with the future depends on what we do today and what we’ve done in the last two weeks,” he said.

More than 300,000 cases of COVID-19 have been reported in the past week, however, authorities believe the actual number of cases was likely double that.

“This wave of infections is already leading to an increase in the number of people with COVID-19,” Professor Kelly said earlier in a statement.

“This will increase pressure on our hospitals, which are already experiencing high levels of patients, and absenteeism due to illness in staff.

“Due to the number of cases, we may also see a rise in the number of people dying with COVID-19, particularly among those who are at higher risk of severe disease.”

More than 5,200 people are in hospital with COVID-19, with health services also under pressure dealing with a range of respiratory illnesses.

Professor Kelly urged Australians to help stem the spread of COVID-19 and take pressure off hospitals by following official health advice.

He said that includes a recommendation to wear masks indoors, even though that is not mandated.

Authorities are also calling on the five million Australians who are overdue for their booster shot to ensure they book it in immediately.