Pfizer Australia and BioNTech SE in the present day introduced that the Therapeutic Goods Administration (TGA) have licensed the businesses’ XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) in people 5 years and older.
Omicron XBB sublineages account for almost all of COVID-19 instances globally2. Although Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines present some safety towards a variety of outcomes from XBB-related COVID-19,3,4 proof means that vaccines higher matched to presently circulating strains might help additional enhance safety towards symptomatic and extreme COVID-19.5
We welcome the TGA’s resolution and commend them for his or her cautious evaluation of the most recent model of Comirnaty. This resolution reaffirms our dedication to carry a high-quality vaccine towards 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,” stated 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 resolution was based mostly on the complete physique of earlier scientific, non-clinical, and real-world proof supporting the protection 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 out there in Australia, together with these out there by the National Immunization Program (NIP).
The use of this vaccine must be in accordance with official suggestions.
COVID-19 vaccines are freed from cost for Australians and can be found in pharmacies and common practices throughout Australia.