Australia’s medical regulator on Friday provisionally approved Pfizer’s coronavirus vaccine for children aged 12 to 15 years.
Health Minister Greg Hunt announced that the Therapeutic Goods Administration (TGA) has ruled that the Pfizer-BioNTech Covid-19 vaccine is safe for the age group, reports Xinhua news agency.
It makes it the first coronavirus vaccine approved for individuals younger than 16 in Australia.
Up until now, the Pfizer vaccine had only been approved for use in Australia for people aged 16 years and above.
In a statement, the TGA said the decision to approve the vaccine for the age group was made after careful evaluation of clinical studies.
“Provisional approval for use in the 12-15 years age group has been made following careful evaluation of the available data supporting safety and efficacy, including clinical studies with adolescents 12 to 15 years of age,” it said.
“The decision has been made on the basis of short term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.”
Hunt said that conversations with the Australian Technical Advisory Group on Immunisation (ATAGI) about rolling out vaccines to vulnerable children were “well advanced”.
“What is more likely, on the early advice I have, is that they will fast track vaccines for 12-15 year-olds for the immunocompromised children, or those with underlying health conditions, and then they’ll review the incoming data over the course of the next month on the general population,” he told the media.
So far there has been about 10.6 million coronavirus vaccine doses administered in Australia.
Approximately 36 per cent of the adult population have received one vaccine dose and 14.9 per cent are fully inoculated.
Since the onset of the pandemic, there has been a total of 32,427 confirmed cases of Covid-19 in Australia, while the death toll stood at 915.