TGA provision nod for all Pfizer's COVID-19 vaccine for booster in 12–15 years old

Australia’ Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer (NYSE: PFE) COVID-19 vaccine, Comirnaty, for use as a booster in individuals aged 12 to 15 years old. The 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 October 26, 2021 and in individuals 16 and 17 years old on January 27, 2022.

Regulatory approval of the booster dose for this age group has also been granted in Israel, the UK and USA. 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.