The Therapeutic Goods Association has approved the Pfizer Covid-19 vaccine has for children aged six months to five years old.
Pfizer now need only approval from the immunisation body ATAGI before the vaccine can be given to babies and toddlers.
Pfizer Australia and New Zealand medical director Dr Krishan Thiru said, if final approvals were given, the vaccine would be given to under-fives in three doses.
He said children with Covid were less likely to grow seriously ill than adults but still faced risks of complications if they did contract the virus.
“Today’s provisional approval is an important reminder for parents to speak to their healthcare professional about COVID-19 vaccination,” he said.
Moderna have already been approved to provide their vaccine to children aged six months to six years, but only for high-risk cases.
It is estimated that about 70,000 children nationwide are at high risk of developing serious illness if they contract COVID-19.
High risk children are those who are severely immunocompromised, have a disability, or who have multiple health conditions.