The Therapeutic Goods Administration (TGA) has provisionally approved a paediatric dose of the Moderna Covid-19 vaccine, for use in children from 6 months to 5 years.
“We are pleased that our vaccine for children under 6 years of age has received provisional approval by the TGA,” says Michael Azrak, General Manager of Moderna for Australia and New Zealand.
“Since the onset of the pandemic, we have worked with a deep sense of responsibility to deliver on the promise of mRNA science to all Australians.”
With the pandemic far from over as seen by the continued evolution of Covid-19, Mr Azrak says global public health, including the health of children, remains at risk.
“The approval from TGA helps extend an opportunity to all parents and caregivers in Australia to protect their young children against [Covid-19],” he says.
Provisional approval in this age group is valid for 2 years and is subject to certain strict conditions, according to the TGA, “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”.
At present, the Moderna Covid-19 vaccine is provisionally approved for people aged 6 years and older (primary series of 2 doses administered at least 28 days apart), and as a booster dose for adults aged 18 years and older.
Until now, children under 6 years old were not eligible for vaccination against Covid-19 in Australia.
The TGA expects that provisionally approving a paediatric dose of the Moderna Covid-19 vaccine will help protect younger children against the most serious outcomes of Covid-19: hospitalisation and death.
Regarding dosing, the TGA recommends that the paediatric dose of the Moderna Covid-19 vaccine be administered in 2 doses at least 28 days apart.
The TGA state that the “paediatric vaccine is made in the same way as the vaccines for older persons; however, it contains a lower concentration of the active ingredient”.
Anyone wanting further information regarding dosing, booster eligibility and interchangeability between vaccines is encouraged to view the Product Information (PI) document, available on the TGA website.
