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.

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

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 authorising 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.

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 on Tuesday 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.

Source: This news is originally published by abc

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