Pfizer Australia and BioNTech SE at the moment introduced that the Therapeutic Items Administration (TGA) have approved 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 circumstances globally2. Though Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines present some safety towards a spread 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 towards symptomatic and extreme COVID-19.5
We welcome the TGA’s resolution and commend them for his or her cautious evaluation of the newest model of Comirnaty. This resolution reaffirms our dedication to deliver a high-quality vaccine towards this virus to Australians.”
Dr Krishan Thiru, Pfizer Australia & New Zealand Medical Director
“In 2022, COVID-19 was considered one of Australia’s main causes of dying, behind coronary heart illness and dementia.6 With at the moment’s resolution, an up to date vaccine will shortly turn into out there that helps deal with a number of Omicron XBB-related sublineages, which at the moment account for the overwhelming majority of COVID-19 circumstances globally.”
“As COVID-19 is predicted to undertake a seasonal sample, much like different respiratory viruses, we stay dedicated to offering COVID-19 vaccines which are which are higher matched to related circulating virus variants or sublineages to individuals worldwide,” mentioned Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The brand new variant-adapted monovalent vaccine goals to additional enhance safety towards extreme sickness and hospitalization brought on by Omicron XBB descendent sublineages which 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 security 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 out there in Australia, together with these out there via the Nationwide Immunization Program (NIP).
Using this vaccine ought to be in accordance with official suggestions.
COVID-19 vaccines are freed from cost for Australians and can be found in pharmacies and normal practices throughout Australia.