Children aged from six months up to six years may soon be eligible for Covid-19 vaccination, after Australia’s drugs regulator approved a paediatric dose of the Moderna vaccine.
The vaccine is already approved for children aged six years and older, who can receive two doses administered at least 28 days apart, and it is also used as a booster dose for adults aged 18 years and older. Currently there is no Covid-19 vaccination available to younger age groups.
In a statement the Therapeutic Goods Administration (TGA) said: “As we have seen with children in older age groups, the TGA expects that vaccines for younger children will provide protection from the most severe outcomes of Covid-19, such as hospitalisation and death.”
For children aged six months to six years, the vaccine is administered as two doses at least 28 days apart. The paediatric vaccine is made in the same way as the vaccines for older people but contains a lower concentration of the active ingredient.
The vaccine was given “provisional approval” by the TGA on Thursday, which means Moderna must continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment. This is the same as for other available vaccines.
Before the vaccine for those aged six months to six years is incorporated as part of the national Covid-19 vaccine program, the Australian Technical Advisory Group on Immunisation (Atagi) needs to also consider the safety and efficacy data provided to the TGA, along with epidemiological data and broader international evidence.
Atagi will also consider current Covid-19 outbreaks, infections and vaccination rates in making its determination. It will then make recommendations about if, how and in what circumstances the vaccine should be rolled out to this age group.
The TGA said Atagi would provide this advice to government “in the coming weeks”.
The federal health minister, Mark Butler, said on Thursday that at the moment there is a very “limited global supply” of the child vaccine. Until Atagi makes its recommendations and supply is secured, the vaccine will not yet be available to young children.
“I want to stress very strongly that this is just the first step in a process,” Butler said.
“Having been approved provisionally by the TGA, this vaccine now needs to go to the technical advisory group on immunisations … until that point, this is simply not a vaccine that would be available to those children. Also, if Atagi does approve that vaccine to children of that group, or a cohort within that age group, then supply of that vaccine also needs still to be arranged.”
In the meantime, parents of those children should take their children for their flu shot, he said.
However the prime minister, Anthony Albanese, seemed optimistic the vaccine would be given Atagi clearance for rollout and that supply would be assured, writing in a post on Instagram; “stay tuned in the coming weeks for more information about how and when to get your children immunised against Covid”.
He added the health department was already procuring the vaccines “so they will be ready to go when our experts give the go-ahead”.
In making its decision, the TGA considered data from the KidCOVE clinical trial in Canada and the United States. The study included more than 6,000 participants aged from six months up to six years.
“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 six months up to six years were mild-moderate and generally reported after the second dose.”
A consultant paediatrician and medical lead of the Melbourne Vaccine Education Centre, Dr Daryl Cheng, said expansion of Covid-19 vaccines to young children would be “a welcome relief for many concerned parents and families”.
“Whilst children are less likely to have severe outcomes or complications from Covid-19 compared with adults, they continue to experience high levels of infection, which disrupts their schooling, childcare and other activities,” he said.
“Children are also at risk of a rare but potentially severe Covid-19 complication known as multi-system inflammatory syndrome. This requires admission to hospital and possibly the intensive care unit. We know that vaccination helps to protect children from this life-threatening condition.”
According to federal Department of Health data, there have been 12 Covid deaths in zero-to-nine year-olds.
