TGA approve new COVID Vaccine

TGA approve new COVID Vaccine

Pfizer Australia and BioNTech SE have announced that the Therapeutic Goods Administration (TGA) has approved the companies’ to release a new COVID-19 vaccine in individuals 5 years and older.1

The Omicron XBB sublineages account for the majority of COVID-19 cases globally.2 The 1.5-adapted monovalent COVID-19 vaccine is targeted towards XBB-related COVID-19. Although Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines provide some protection against a range of outcomes from XBB-related COVID-1,3,4 evidence suggests that the vaccine is better matched to currently circulating strains with help to improve protection against symptomatic and severe COVID-19.5

“We welcome the TGA’s decision and commend them for their careful assessment of the latest version of Comirnaty. This decision reaffirms our commitment to bring a high-qualityvaccine against this virus to Australians,” said Dr Krishan Thiru, Pfizer Australia & New Zealand Medical Director.

“In 2022, COVID-19 was one of Australia’s leading causes of death, behind heart diseaseand dementia.6 With today’s decision, an updated vaccine will shortly become available that helps address multiple Omicron XBB-related sublineages, which currently account for the vast majority of COVID-19 cases globally.”

“As COVID-19 is expected to adopt a seasonal pattern, similar to other respiratory viruses, we remain committed to providing COVID-19 vaccines that are that are better matched to relevant circulating virus variants or sublineages to people worldwide,” said Prof. Ugur

Sahin, M.D., CEO and Co-founder of BioNTech. “The new variant-adapted monovalent vaccine aims to further improve protection against severe illness and hospitalisation caused by Omicron XBB descendent sublineages that are antigenically distant from prior Omicron strains.”

The TGA’s decision was based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines.

COVID-19 vaccines are free of charge for Australians and are available in pharmacies and general practices across Australia.


  1. Australian Government Department of Health and Aged Care. ARTG Public Summary documents

COMIRNATY Omicron XBB.1.5 (raxtozinameran). Available Accessed October 2023.

  1. World Health Organization. COVID-19 Weekly Epidemiological Update: Edition 158 published 1 September 2023. Available at:—1-september-2023
  1. Link-Gelles R, Ciesla AA, Roper LE, et al. Early estimates of bivalent mRNA booster dose vaccine

effectiveness in preventing symptomatic SARS-CoV-2 infection attributable to Omicron BA.5– and

XBB/XBB.1.5–related sublineages among immunocompetent adults — Increasing community access to testing program, United States, December 2022–January 2023. MMWR Morb Mortal Wkly

Rep 2023;72:119–124. doi:

  1. Link-Gelles R, Weber ZA, Reese SE, et al. Estimates of bivalent mRNA vaccine durability in preventing COVID-19–associated hospitalization and critical illness among adults with and without immunocompromising conditions — VISION Network, September 2022–April 2023. MMWR Morb Mortal Wkly Rep 2023;72:579–588. DOI:
  1. Khoury DS, Docken SS, Subbarao K, Kent SJ, Davenport MP, Cromer D. Predicting the efficacy of variant-modified COVID-19 vaccine boosters. Nature Medicine. 2023 Mar;29(3):574-8. Available at:
  1. Australian Bureau of Statistics. (2022). Causes of Death, Australia. ABS.

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