Pfizer Australia and BioNTech announce TGA approval for Omicron XBB.1.5-adapted monovalent COVID-19 vaccine
Pfizer Australia and BioNTech SE right this moment introduced that the Therapeutic Items 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. Though Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines present some safety in opposition to a variety of outcomes from XBB-related COVID-19,3,4 proof means that vaccines higher matched to at the moment circulating strains can assist additional enhance safety in opposition to symptomatic and extreme COVID-19.5
We welcome the TGA’s determination and commend them for his or her cautious evaluation of the most recent model of Comirnaty. This determination reaffirms our dedication to convey a high-quality vaccine in opposition to this virus to Australians.”
Dr Krishan Thiru, Medical Director of Pfizer Australia & New Zealand
“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 determination was based mostly on the total 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 Well being and Aged Care on the medical administration of vaccines obtainable in Australia, together with these obtainable via the Nationwide Immunization Program (NIP).
The usage of this vaccine needs to 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.
