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Therapeutic Goods Administration (TGA) approves Pfizer vaccine for 12 to 15-year-olds

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In a press release, Minister for Health and Aged Care, Greg Hunt, applauds the Therapeutic Goods Administration’s (TGA) decision to allow 12 to 15-year-olds to get vaccinated.

Minister Greg Hunt’s statement:

Australia’s COVID-19 vaccination rollout has taken another step forward with the Pfizer vaccine being approved for use in children aged 12 to 15 years.

The Therapeutic Goods Administration (TGA) has thoroughly, and independently, assessed the domestic and international evidence before extending its approval for the Pfizer vaccine to be administered to this age group.

Up until now, the Pfizer vaccine had only been approved for use in Australia for people aged 16 years and over.

The TGA’s approval is a very important step in the process.

As with all of our vaccination decisions associated with the COVID-19 pandemic, the Australian Technical Advisory Group on Immunisation (ATAGI) will now consider this approval and provide expert advice on which groups of adolescents should be prioritised for the rollout of the vaccine and how and when it should be administered.

ATAGI has been meeting with global experts over recent days to inform their deliberations and expert advice.

The National COVID-19 Vaccines Taskforce has been undertaking detailed planning to support the rollout of the COVID-19 vaccine for children, following approval from the TGA and in line with the expert medical advice from ATAGI.

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.

TGA’s statement:

The Therapeutic Goods Administration (TGA) has provisionally approved the use of the Pfizer BNT162b2 COVID-19 vaccine (COMIRNATY) in individuals 12 years and older. Previously, the Pfizer COVID-19 vaccine was provisionally approved for use in individuals 16 years or older.

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. Use in this age group was supported by the independent expert Advisory Committee on Vaccines.

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