The Therapeutic Goods Administration provisionally approved the use of the Moderna COVID-19 vaccine, Spikevax, for children six months of age and older.
The mRNA vaccine was recently cleared for use in Australia for others over the age of six, but Tuesday’s TGA resolution could allow the younger cohort to receive any of the injections.
“As we have seen with young people in older age groups, TGA expects youth vaccines to provide coverage against the more serious consequences of COVID-19, such as hospitalization and death,” a TGA said.
Health Minister Mark Butler has shown that he will wait for the recommendation of the Australian Technical Advisory Group on Immunization (ATAGI) before implementing Spikevax in young children.
“There are still a number of steps that need to be taken before we can make this vaccine available to parents and their very young children,” he said Tuesday.
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“If I had a message for parents of children under five today, it’s to get your kids vaccinated against the flu. “
Butler told the news conference that the vaccine has been rolled out to U. S. youth in recent weeks.
The TGA said its jab review procedure is “rigorous and of the highest quality” and also reported through the specialized forums of the Vaccine Advisory Committee.
ATAGI has only approved the Pfizer Comirnaty vaccine for children five years and older, while the Moderna Spikevax vaccine has been approved for children six years and older.
The TGA made its decision after reviewing knowledge of the KidCOVE clinical trial that was conducted in Canada and the United States with more than 6,000 participants aged between six months and six years.
“The study demonstrated that the immune reaction to the vaccine in young people is similar to that seen in young adults (18 to 25 years old) with a favorable protection profile,” the TGA said.
“Most adverse events observed in clinical trials in children older than 6 months to 6 years were mild to moderate and were reported after the current dose.
“These irritability/crying, redness and/or swelling at the injection site, fatigue, fever, muscle pain, and swelling or axillary (groin) tenderness. “
The Moderna vaccine is given in two doses 28 days apart as for adults.
The dose will be lower, with children older than six months to five years getting 25 micrograms of vaccine in a 0. 25 ml vial.
Children older than 6 to 11 years will get 50 micrograms in a dose of 0. 25 ml and those over 12 years old will get one hundred micrograms in a 0. 5 ml vial of the vaccine.
Provisional approval of the formative years vaccine through the TGA is valid for two years and is subject to strict conditions, adding moderna’s legal responsibility to continue to provide the TGA with data on the long-term efficacy and protection of the Spikevax vaccine.
The provisional approval of the TGA is the first step for a vaccine to enter service in Australia and indicates that it has met the “high safety and efficacy criteria” established through the TGA.
“The prospective use of this vaccine in the national COVID-19 vaccination program has not yet been determined, adding the use in which, if any, young people in this age organization,” the TGA wrote.
“As with all COVID-19 vaccines, the Australian Immunization Technical Advisory Group (ATAGI) will provide guidance to the government on those issues in the coming weeks. “
The provisional approval comes as fitness experts warn that the Omicron wave looms on the horizon amid the emergence of subvariants, BA. 4 and BA. 5.
COVID-19 infections, as well as flu cases, are on the rise and citizens have been asked to show up to receive their third and fourth booster shots to increase their coverage this winter.