THE Therapeutic Goods Administration (TGA) is evaluating an application to extend its approval of Moderna's COVID-19 vaccine (COVAX) to immuise children aged six months and older.
In a statement released last week the regulator noted that the mRNA-based vaccine has been granted provisional approval for immunisation to prevent COVID-19 in individuals aged six years and older, and as a booster for adults aged over 18 years.
Under the application, the TGA is assessing a proposed two-dose schedule of 25 micrograms in 0.25mL, for infants aged six months to five years, compared to the 50 micrograms in 0.25mL administered to children aged five to 11 years, and 100 micrograms in 0.5mL doses given to patients aged 12 years and older.
"mRNA vaccines use a genetic code to enable the production of the coronavirus spike protein," the TGA said.
"Immune cells then recognise the spike protein as foreign and begin building an immune response against it.
"The RNA from the vaccine does not change or interact with our DNA in any way."
With several jurisdictions across the country automatically authorising pharmacists to administer COVAX in line with TGA approvals, a green-light from the regulator for the vaccine to be used in infants, would further expand the scope of practice for pharmacists in the relevant States.
If approved pharmacy organisations are likely to renew their calls for increased remuneration for administering primary doses of the COVAX to younger patients.
Sources have described the current $16 fee for administering an initial dose of a COVAX as "inadequate", noting that paediatric vaccines take longer to provide.
Meanwhile, the US Food and Drug Administration is expected to approve Pfizer's COVAX as a booster for children age five to 11 years later this week.
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