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Pfizer's COVID-19 vaccine (COMIRNATY) provisionally approved for use as a booster in individuals aged 16-17 years old

28 January 2022

The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use as a booster in individuals aged 16 and 17 years old.

This decision follows the provisional approval granted by the TGA to Pfizer for the use of COMIRNATY as a booster in individuals 18 years and older on 26 October 2021. Booster doses of COMIRNATY in this age group have been approved for use in the US, Israel and the UK.

Dosing in this age group is the same as the adult population - a booster dose of COMIRNATY may be administered intramuscularly after the completion of a COVID-19 vaccine primary series (2 doses). This primary series can be of any of the COVID-19 vaccines approved for use in in this age group, although data on the use of COMIRNATY as a booster with other COVID-19 vaccines is more limited.

Further information and more detailed information on the use of this vaccine is available on the TGA's website via the Product Information.

The Australian Technical Advisory Group on Immunisation (ATAGI) will shortly provide advice and further information on when this age group is eligible to receive booster doses.

The TGA continues to monitor ongoing trials associated with booster doses for younger children.

Provisional approval of this vaccine is valid for two years and means it can now be legally supplied in Australia. The approval is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment.

Australians can be confident that the TGA's review process of this vaccine was rigorous and of the highest standard. The decision to provisionally approve the vaccine was also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.

The TGA will continue to actively monitor the safety of the vaccine in all age groups both in Australia and overseas and will not hesitate to take action if safety concerns are identified.

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