Australia the first to approve Moderna vaccine in young children

The Therapeutic Goods Administration (TGA) has provisionally approved the Moderna COVID-19 vaccine, Spikevax, for use in people aged six years and older.
 
The decision means Australia now has two vaccine candidates available for young children, after the rollout of paediatric Pfizer doses commenced in January.
 
Associate Professor Paul Griffin, an infectious diseases physician and clinical microbiologist at the University of Queensland, said the approval – the first anywhere for Moderna among this cohort – is ‘more welcome news’.
 
‘With school going back and the transmission we have seen in this age group in recent times, the importance of comprehensive, yet reasonable mitigation strategies, including vaccination, has been highlighted,’ he said.
 
‘While it has been pleasing to see many children in the 5–11-year age range already come out and receive their vaccine – my three children included – the uptake in this age range in our country is still less than 50%.
 
‘Adding another safe and effective vaccine option should hopefully help further increase uptake in this age group.’
 
Associate Professor Griffin added that data supporting Moderna’s use in this age group is ‘clear’, thanks to a large study of around 4000 children conducted in the USA and Canada, which demonstrated high rates of both efficacy and safety.

‘This of course is in addition to this vaccine being successfully used in our country and many others, in older children and adults, as well as the successful use of the other mRNA vaccine produced by Pfizer in children down to five years of age here in Australia already,’ he said.
 
Upon announcing its decision, the TGA also referred to ‘carefully’ considering data from the KidCOVE clinical trial cited by Associate Professor Griffin, which demonstrated that the immune response and safety profile in children is similar to that seen in older age groups.
 
The most frequent adverse events seen in clinical trials include injection site pain, redness and/or swelling, axillary (groin) swelling or tenderness, fatigue, headache, fever and muscle pain.
 
Much like Pfizer’s paediatric COVID vaccine, children aged 6–11 will receive the same vaccine approved for use among those 12 and older, albeit at a reduced dosage (0.25 mL vs 0.5 mL).
 
‘Provisional approval of this vaccine for individuals six years and older is valid for two years,’ the TGA statement announcing the decision read.
 
‘The approval is subject to certain strict conditions, such as the requirement for Moderna to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.
 
‘Australians can be confident that the TGA’s review process of this vaccine was rigorous and of the highest standard.’
 
Advice from the Advisory Committee on Vaccines – an independent committee with expertise in scientific, medical and clinical fields, including consumer representation – was also sought as part of the approval process.
 
The TGA has said it will continue to actively monitor the safety of the vaccine in children and adults both in Australia and overseas and ‘will not hesitate to take action’ if concerns are identified.
 
The Australian Technical Advisory Group on Immunisation (ATAGI) is also expected to provide further guidance on the vaccine’s rollout in this cohort, while the TGA will publish the Australian Public Assessment Report for its decision in the coming days.
 
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COVID-19 Moderna paediatrics vaccination