TGA provisionally approves Pfizer’s COVID-19 vaccine (COMIRNATY), for use as a booster for individual aged 12–15 years old

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 12 to 15 years old. TGA provisional approval is the first step in the two green light approval process consistently applied throughout the COVID 19 Vaccine program.

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 and in individuals 16 and 17 years old on 27 January 2022.

A booster dose of COMIRNATY may be administered intramuscularly at least 6 months after the completion of a COVID-19 vaccine primary series (2 doses) in individuals aged 12 years and over. The primary series can be of any of the COVID-19 vaccines approved for use in this age group, although data on the use of COMIRNATY as a booster with other COVID-19 vaccines is limited.

Regulatory approval of the booster dose for this age group has also been granted in Israel, the United Kingdom and the United States. The TGA continues to work very closely with international regulators to align regulatory approaches, share information and, where it speeds up evaluation, collaboratively review COVID-19 vaccines and treatments.

Australians can be confident that the TGA's review process for 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.

The Australian Public Assessment Report for this decision will be published in the coming days. The Australian Technical Advisory Group on Immunisation (ATAGI) will provide advice shortly on whether this vaccine should be included in the COVID-19 Vaccine program as the final step in the two green light approval process.

Contact for members of the media:

• Email: news@health.gov.au; Phone: 02 6289 7400