After carefully considering data from the KidCove clinical trial, the Therapeutic Goods Administration (TGA) has provisionally approved the use of Moderna’s Covid-19 vaccine, Spikevax, in children aged 6-11 years.
The decision follows the provisional approvals granted by the TGA to Moderna for use in individuals aged 12 years and older on 3 September 2021, and the Moderna booster dose for use in adults 18 years and older on 7 December 2021.
As for other age groups, the use of this vaccine in children aged 6-11 years should be administered as two doses at least 28 days apart.
The same vaccine preparation employed for older age groups will be used, however, a lower dose of 0.25mL (50 micrograms) will be given to children 6-11 years, compared to the 0.5mL (100 microgram) dose used for those 12 years and older.
In making this regulatory decision, it has been reported that the TGA carefully considered data from the KidCOVE clinical trial, which was conducted at multiple sites throughout Canada and the United States and included up to 4000 participants aged 6 to 11 years. The study demonstrated that the immune response to the vaccine in children was similar to that seen in older age groups.
Clinical trials also reportedly show that the safety profile in children is similar to that seen in adults. The most frequent adverse events seen in clinical trials in children aged 6-11 years were short-term and included injection site pain, redness and/or swelling, axillary (groin) swelling or tenderness, fatigue, headache, fever and muscle pain.
Further advice on the rollout Moderna’s Spikevax vaccine in this age group will be provided to Government by the Australian Technical Advisory Group on Immunisation (ATAGI).
According to the TGA, Provisional approval of this vaccine for individuals 6 years and older is said to be valid for two years.
The said to be 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.
“The TGA authorisation for the use of our Covid-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorisation for the use of our vaccine in this age group,” says Stéphane Bancel, Chief Executive Officer of Moderna.
“We are grateful to the TGA for their diligence and the Government of Australia for its continued confidence in our mRNA platform.
“We are grateful for the opportunity to provide protection against Covid-19 to this important age group, keeping children safe and able to continue life as normally as possible.”
Professor Robert Booy from the Immunisation Coalition says: “I welcome this decision by the TGA and look forward to the uptake of vaccination in children increasing even more to provide protection of children and maximise school attendance.”