The Therapeutic Goods Administration (TGA) has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 months to less than 6 years (6 months to 5 years).
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Currently this mRNA vaccine is provisionally approved for immunisation to prevent COVID-19 in individuals aged 6 years and older (primary series of 2 doses administered at least 28 days apart), and as a booster dose for adults aged 18 years and older.
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 hospitalization and death.
As with other age groups, the use of this vaccine in children from 6 months should be administered as 2 doses at least 28 days apart.
The paediatric vaccine is made in the same way as the vaccines for older persons, however it contains a lower concentration of the active ingredient:
• 6 months to less than 6 years (6 months to 5 years) - 25 micrograms in 0.25ml vial
• 6 to 11 years - 50 micrograms in 0.25ml vial
• 12 years and older - 100 micrograms in 0.5ml vial
In making this regulatory decision, the TGA carefully considered data from the KidCOVE clinical trial, which was conducted at multiple sites throughout Canada and the United States and included over 6000 participants aged 6 months up to 6 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.
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 6 months up to 6 years were mild-moderate and generally reported after the second dose.
These included irritability/crying, redness and/or swelling at injection site, fatigue, fever, muscle pain and axillary (groin) swelling or tenderness.
Provisional approval of this vaccine in this age group is valid for two years. 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. ■