The Australian Technical Advisory Group on Immunisation (ATAGI) has been meeting with global experts to assist their deliberations on a new provisional approval to administer Pfizer for 12- to 15-year-olds.
Health minister Greg Hunt issued a statement on Friday announcing that once ATAGI’s 16 expert member had considered their position on the Therapeutic Goods Administration’s (TGA) provisional approval of the COVID-19 vaccine Pfizer for children 12 years, the national vaccines taskforce would plan how it would be delivered to children.
Hunt said the TGA’s provisional approval of Pfizer was an important step along the way to have younger Australians vaccinated against the virus.
“The Australian government has been consistently following the advice of our medical experts in order to roll out COVID-19 vaccines as quickly, and safely, as possible,” Hunt said.
“As with all of our vaccination decisions associated with the COVID-19 pandemic, the ATAGI will now consider this approval and provide expert advice on which groups of adolescents should be prioritised for the roll out of the vaccine and how and when it should be administered.”
Previously, the TGA had given provisional approval for the Pfizer COVID-19 vaccine to be administered to people 16 years and over. Current data shows that 22,050 eligible Australians between the ages of 16-19 have been fully vaccinated against COVID-19 to date.
The TGA’s new position extends the provisional approval of two doses of the vaccine (0.3mL per dose) to people aged 12 to 15 years.
“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,” a TGA statement read.
“Use in this age group was supported by the independent expert Advisory Committee on Vaccines.”
An Australian public assessment report published by the TGA noted that the provisional approval had been made based on short term efficacy and safety data. Ongoing approval would depend on evidence of longer term efficacy and safety from ‘ongoing clinical trials and post-market assessment’, the TGA said.
The health minister added that the TGA’s process was thorough and independent, relying on data from Australia and overseas.
“ATAGI has been meeting with global experts over recent days to inform their deliberations and expert advice,” he said.