The Therapeutic Goods Administration (TGA) has approved a vaccine against COVID-19 for young children, with negotiations underway to ensure doses of a “very limited supply”.
On Tuesday, the TGA provisionally approved a pediatric dose of the Modern COVID-19 mRNA vaccine, Spikevax, for children aged six months to six years.
It is the first time a vaccine for this age group has received provisional approval in Australia.
The TGA has provisionally approved a pediatric dose of the Modern COVID-19 vaccine for young children. (Bloomberg)
“Australians can be confident that the process of reviewing this vaccine by the TGA was rigorous and of the highest standard,” the TGA said in a statement.
“The decision to provisionally approve the vaccine was also informed by the expert advice of the Vaccine Advisory Committee (VAC), an independent committee with experience in scientific, medical and clinical fields, including consumer representation.”
Health Minister Mark Butler said the ATAGI advisory group still needed to give the green light for young Australians to receive the vaccine.
“Until then, it’s just not a vaccine available for these kids,” Butler said.
“If ATAGI approves this vaccine for children in this group, or a cohort within this age group, the supply of this vaccine should also be arranged.”
Butler said there were supply issues with the Modern vaccine for young children, which is different from the vaccine for adults.
He said the government was trying to secure “as many doses as we can” and that it was in “active negotiations”.
“I want to emphasize that, despite this good news, the TGA is able to approve this Modern product … there is still no action that parents can take or that needs to be done to seek an appointment or not,” Butler . dit.
“There are still a number of steps that need to be taken before we are in a position to make this vaccine available to parents and their very young children.”
Health Minister Mark Butler said the interim approval was just the first step in a process to make the vaccine available to young children. (new)
The TGA said the decision was based on clinical trials in the United States and Canada, which included 6,000 participants.
“Clinical trials also showed that the safety profile in children is similar to that observed in adults.
“Most of the adverse events observed in clinical trials in children aged six months to six years were mild-moderate and were generally reported after the second dose.”
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The TGA said children under the age of six were recommended two doses of Moderna, which were to be given 28 days apart.
The approval is valid for two years and the TGA will require Moderna to provide updated data on its effectiveness.