Pfizer Australia and BioNTech announce TGA approval for Omicron XBB.1.5-adapted monovalent COVID-19 vaccine

Pfizer Australia and BioNTech SE today announced that the Therapeutic Goods Administration (TGA) have authorized the companies’ XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) in individuals 5 years and older.

Omicron XBB sublineages account for the majority of COVID-19 cases globally2. Although Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines provide some protection against a range of outcomes from XBB-related COVID-19,3,4 evidence suggests that vaccines better matched to currently circulating strains can help further 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-quality vaccine against this virus to Australians.”

Dr Krishan Thiru, Pfizer Australia & New Zealand Medical Director

“In 2022, COVID-19 was one of Australia’s leading causes of death, behind heart disease and 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 hospitalization 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.

The Australian Technical Advisory Group on Immunization (ATAGI) advises the Minister for Health and Aged Care on the medical administration of vaccines available in Australia, including those available through the National Immunization Program (NIP).

The use of this vaccine should be in accordance with official recommendations.

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

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