ATAGI releases Moderna guidance for children aged 6–11

Paediatric doses of Moderna’s COVID-19 vaccine will be available to children over the age of six as of Thursday, 24 February.
 
The Australian Technical Advisory Group on Immunisation’s (ATAGI) recommendation follows the Therapeutic Goods Administration’s (TGA) provisional approval of the vaccine for the young cohort earlier this month.
 
RACGP President Dr Karen Price welcomed the decision as ‘good news’ for Australian families.
 
‘Children aged 5–11 can already receive the Pfizer COVID-19 vaccine, and now parents and carers also have the option of the Moderna vaccine,’ she said.
 
‘Both vaccines are extremely safe and effective, and we need children vaccinated as soon as possible.’
 
In a statement issued by ATAGI, the advisory group recommends that children aged 6–11 receive a two-dose schedule of 50 μg (0.25 mL) per dose – half of the primary dose administered to people aged 12 and over, but the same as the booster dose – with an interval of eight weeks.
For children who are severely immunocompromised, a third dose is recommended.
 
ATAGI has also flagged the potential for dosing errors, as unlike Pfizer there are no paediatric vials of Moderna, which require immunisation providers to draw up the dose from the standard vial.
 
‘Inadvertent administration of a 100 μg dose to a child 6–11 years of age is likely to result in an increased risk of adverse reactions, as was observed in the first [dose-finding] part of the clinical trial conducted by Moderna,’ the statement reads.
 
‘Should this occur, an adverse event following immunisation [AEFI] report should be submitted using established mechanisms.’
 
Meanwhile, the advisory group has advised that the recommended eight-week interval can be shortened to four weeks for children who are considered to be at risk of moderate-to-severe COVID-19, such as those who have underlying health conditions, reside in an outbreak area or are planning international travel.
 
Pfizer’s paediatric vaccine continues to be the only COVID-19 vaccine approved for children aged five.
 
So far 49.4% of 5–11-year-olds in Australia have received at least one dose of a COVID-19 vaccine, but the daily number of doses being administered to this cohort has plummeted since the early weeks of the rollout.
 
Nine Newspapers recently reported there has been an 89% drop, down from 47,000 daily doses to less than 5000.
 
But on Tuesday, Federal Health Minister Greg Hunt said that the sentiment tracking among parents has found a 76% intention rate to get children vaccinated.
 
‘This is an important indicator. It means that the will is there,’ he said.
 
To reach this target, around 600,000 additional children will need to receive a first dose.
 
To help boost uptake, a group of health experts and government officials will meet next week for a roundtable set to be convened by vaccine expert Professor Julie Leask from the University of Sydney.
 
Dr Price acknowledged that Australia is doing well in its efforts compared to most other countries, and encouraged more families to come forward while calling on any parents and carers who may be feeling uncertain to seek advice from their GP.
 
‘We are here to help,’ she said.
 
The TGA is the first regulator in the world to approve Moderna for this age group based on data from the KidCOVE clinical trial, which included close to 4000 children aged 6–11 across Canada and the US.
 
‘Preliminary data suggest that this vaccine elicits strong antibody responses,’ ATAGI’s statement reads.
 
‘Most side effects are mild-to-moderate and transient in nature, similar to those observed in children who have received the Pfizer vaccine.’
 
However, the advisory group does note that side effects ‘may be more common’ following Moderna than Pfizer.
 
Due to a lack of published data in this age group, mixed primary schedules in this cohort are not recommended.
 
Both paediatric doses of Pfizer and Moderna can be co-administered with non-COVID-19 vaccines, but ATAGI says parents and guardians should be made aware that this ‘may increase the likelihood of mild-to-moderate side effects’.
 
While COVID-19 infection in children aged 6–11 years without pre-existing conditions is generally asymptomatic or causes a brief illness with mild symptoms, ATAGI says that there is emerging evidence to suggest vaccination may protect against paediatric inflammatory multisystem syndrome – a rare, but potentially life-threatening syndrome occurring in around one in 3000 children post-infection.
 
‘In addition to an anticipated reduction in illness … vaccination is also indirectly expected to reduce the need for isolation in children, disruption to education and social activities, and potentially a reduction in parental absenteeism,’ the statement reads.
 
As vaccination efforts continue, Dr Price issued a reminder to governments that GPs and general practice teams are ‘seriously under the pump and need more assistance’.
 
In addition to delivering booster doses, the college President noted that vaccinating children is a more complicated process compared to vaccinating adults and takes more time.
 
‘On top of all of that, we are managing our day-to-day patient caseload – people haven’t stopped getting sick and injured just because we are busy with the vaccine rollout,’ Dr Price said.
 
‘GPs are paying particularly close attention to people who have delayed or avoided screenings and consults during the pandemic, as well as patients experiencing serious mental health concerns which have been exacerbated by lockdowns and other facts linked to the pandemic.’
 
In 2021, the Federal Government announced an additional $10 per patient for practices delivering booster doses. But since then, Dr Price says the workload has escalated and if general practice is to continue being the ‘backbone’ of the rollout that ‘more help from the Federal Government’ is needed.
 
‘We need more funding and support for general practice teams, this will enable more practices to run after-hours and weekend vaccination clinics,’ she said.
 
‘GPs and their teams didn’t decide to participate in the rollout to make money, but the reality is that practices do have to make ends meet.’
 
The next cohort in line to become eligible for vaccination is children aged under five. But TGA Head Professor John Skerritt said on Tuesday that he is not expecting progress until ‘well after Easter’.
 
‘[The] FDA has actually put on ice, I think is the best way to say, their review of the data,’ he said.
 
‘It is clear that, especially for certain ages, there’s the need for either a third dose or a higher dose, and that is by Pfizer. And so Pfizer are now conducting some further trials.’
 
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