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 businesses’ 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 vast majority of COVID-19 cases globally2. Although Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines provide some protection against a variety of outcomes from XBB-related COVID-19,3,4 evidence suggests that vaccines higher matched to currently circulating strains may also help further improve protection against symptomatic and severe COVID-19.5

We welcome the TGA’s decision and commend them for his or her careful assessment of the most recent version of Comirnaty. This decision reaffirms our commitment to bring a high-quality vaccine against this virus to Australians.”

Dr Krishan Thiru, Pfizer Australia & Latest Zealand Medical Director

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

“As COVID-19 is anticipated to adopt a seasonal pattern, just like other respiratory viruses, we remain committed to providing COVID-19 vaccines which are which are higher matched to relevant circulating virus variants or sublineages to people worldwide,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The brand new variant-adapted monovalent vaccine goals to further improve protection against severe illness and hospitalization brought on by Omicron XBB descendent sublineages which are antigenically distant from prior Omicron strains.”

The TGA’s decision was based on the total body of previous clinical, non-clinical, and real-world evidence supporting the security 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 usage of this vaccine must be in accordance with official recommendations.

COVID-19 vaccines are freed from charge for Australians and can be found in pharmacies and general practices across Australia.