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COVID vaccination for children aged 5–11 to begin in January


Anastasia Tsirtsakis


10/12/2021 3:40:20 PM

Pfizer’s paediatric vaccine has received its final approval, with ATAGI’s clinical guidance recommending a dosage interval of eight weeks.

A child receiving a COVID-19 vaccine.
A recent clinical trial involving children aged 5–11 found Pfizer’s COVID-19 vaccine to be safe and highly effective.

Australia is following in the footsteps of the United States, with Pfizer’s paediatric vaccine given the green light and GPs expected to start vaccinating 5–11-year-old’s from 10 January.
 
The Australian Technical Advisory Group on Immunisation (ATAGI) issued its final recommendations late on Thursday (9 December) after the Therapeutic Goods Administration (TGA) provisionally approved the vaccine’s use for the young cohort on Sunday.
 
Children aged 5–11 will be eligible to receive a new, lower dose formulation of Pfizer’s COVID-19 vaccine of 10µg (0.2mL) – a third of the recommended 30µg dose being administered to people aged 12 and over.
 
While the advisory group recommends two doses, the dosing interval is eight weeks, unlike the three week interval for older cohorts.
 
Canadian authorities have taken the same approach, with the TGA’s National Manager Professor John Skerritt saying a longer interval between doses appears to generate a ‘stronger immune response’.
 
ATAGI has advised that the interval can be shortened in ‘special circumstances’, however, to a minimum of three weeks. Possible scenarios include:

  • children who are in outbreak areas
  • prior to the initiation of significant immunosuppression
  • prior international travel.
As with people aged 12 and over, children aged 5–11 who have previously tested positive to COVID-19 can receive the vaccine, but it is recommended ‘following recovery from their illness or vaccination can be deferred for up to six months’. This also includes children with a past history of paediatric multisystem inflammatory syndrome (PIMS-TS) or post-COVID-19 condition, also known as long COVID.
 
More than two million children aged 5–11 will be eligible for vaccination, and the Federal Government has flagged that bookings will open later this month ahead of the program’s commencement on 10 January.
 
Along with general practices, parents and carers will be able to access vaccination for their children in pharmacies, Aboriginal health services and state-run vaccination hubs. States and territories will decide whether to run school-based vaccination programs.
 
In addition to clinical trial data, ATAGI was also able to draw on significant real-world data, including more than five million children aged 5–11 who have received at least one dose in the United States.
 
Dr James Best, Chair of RACGP Specific Interests Child and Young Person’s Health, welcomed the news, saying it is a ‘fantastic opportunity’ to protect younger children.
 
‘It’s great that ATAGI feel that they have the evidence to go this step,’ he told newsGP.
 
‘Even though the rate of complications is lower the lower you go in age, it still happens.
 
‘And we also have the other factor of PIMS-TS coming into the equation, as well as indirect effects like loss of school time and lack of socialisation, as well as secondary infection to household carriers who may be at higher risk, like the elderly. So there’s quite a few different factors coming into play.’
 
A recent clinical trial conducted by Pfizer involving 2268 children aged 5–11, of whom 1517 were given two doses of 10µg three weeks apart, found the vaccine to be safe and 90% effective at preventing symptomatic COVID-19, with three children testing positive.  
 
Despite the lower dose, antibody levels after the second dose were similar to those observed in people aged 16–25.
 
When it came to post-vaccine side effects, most were found to be mild, transient and similar to those experienced by adults, including a sore arm, tiredness and headache. There were also no cases of myocarditis or pericarditis reported.
 
While the cohort was relatively small, the longer interval between doses could also help to stave off inflammation of the heart. A Canadian study involving participants aged 18–24 found a longer dosing interval resulted in lower rates of myocarditis.
 
Currently in Australia, children under 12 account for more than a fifth of all COVID-19 cases.
 
ATAGI said its recommendations take into account both the direct benefits of vaccination for the child in preventing illness, but also the indirect benefits for their family and for the broader community.
 
It notes that children aged 5–11 years with medical risk factors for severe illness, Aboriginal and Torres Strait Islander children, and children living in crowded conditions or outbreak areas are most likely to benefit from COVID-19 vaccination given their increased risk of severe outcomes and/or exposure.
 
However, for some of the overarching benefits to be realised, the advisory group notes that ‘a large proportion of the 5–11 year age group would need to be vaccinated’.
 
While GPs have been central to Australia’s vaccination efforts, Dr Best said he expects that work to go up a notch during the next phase of the rollout. He said that while some parents and carers were keen to get their children vaccinated as soon as possible, he expects others will be feeling an increased level of anxiety.
 
‘I just think with younger children, that whole conversation has a higher emotional content. So it’s going to probably make for some really complicated conversations,’ he said.
 
‘But I think that that’s what GPs are there for; that’s what we do well. We know our patients and our patients know us, and it’s that trusted voice that really is so critical to dealing with anxieties that people might have.
 
‘The counter to that may be that people are getting more used to the idea of getting a COVID vaccination. The parents and carers may well have been vaccinated themselves now, and so they may feel more comfortable with it.’
 
As with the vaccine rollout previously, a key to its success will be supply.
 
However, ATAGI has assured that adequate supply of the paediatric vials are ‘expected to be available to vaccinate all 5–11-year-old children’, with the first shipment expected to arrive in Australia in early 2022. The TGA will then undertake a batch test before distributing them to vaccination sites across the country.
 
Department of Health Secretary Professor Brendan Murphy said anyone administering the vaccines will also need to be brought up to speed on the clinical recommendations.
 
‘We have to train all of the vaccination providers who need this new formulation,’ he said.
 
‘So it’s going to take some weeks and that’s why it’ll start on the 10th of January when everyone’s ready.’
 
Dr Best said it is going to be interesting to see how the rollout unfolds, with sights now set on the pragmatics.
 
‘The GPs of Australia have become very used to having to deal with change, and this is the next phase of the battle,’ he said.
 
‘So onward and forward.’
 
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