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- SPIKEVAX, Moderna’s COVID-19 vaccine, has secured provisional approval from the Australian drugs regulator for use in children aged six years and older.
- The vaccine dose in the age group of 6-11 years will be lower compared to individuals aged 12 years and older.
- The TGA considered KidCOVE clinical trial data before provisionally approving the vaccine.
Australian drugs regulator Therapeutic Goods Administration (TGA) has given a green signal for the use of Moderna’s COVID-19 vaccine, SPIKEVAX. With the TGA provisional approval, Spikevax can now be given to individuals aged six years and older.
SPIKEVAX is the second vaccine approved for immunizing children against COVID-19 in Australia. In December 2021, The TGA provisionally approved Pfizer’s COMIRNATY vaccine for kids aged 5-11 years.
Earlier in September 2021, SPIKEVAX received the TGA provisional approval for use in individuals aged 12 years and older.
Moreover, a booster dose of SPIKEVAX was given provisional approval for use in adults aged 18 years and older in December 2021.
In children aged 6-11 years, two doses of the vaccine should be given at a gap of at least 28 days, just like other age groups. However, the vaccine dose will vary. A lower dose of 0.25ml will be given to the age group of 6-11 years compared to 0.5ml for individuals aged 12 years and above.
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The TGA decision was based on KidCOVE clinical trial data, and the vaccine under study was called mRNA-1273. The trial was conducted in Canada and the United States.
The trial of up to 4,000 participants demonstrated that the immune response of children to the vaccine is like that of older age groups. The safety profile was also the same.
However, some short-term adverse effects were seen, such as injection site pain, redness or swelling, fever, muscle pain, and headache.
The vaccine for this age group has got provisional approval for two years. Moderna must provide updates to the TGA on long-term effectiveness and security from ongoing clinical trials and post-market assessments.
Moderna’s COVID-19 vaccine is based on messenger RNA (mRNA). The mRNA trains the cells in the body to create an effective immune response to the COVID-19 virus. This protects from getting sick with COVID-19 in the future.
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