Pfizer Australia and BioNTech SE in the present day 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 circumstances globally2. Though 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 will help additional enhance safety towards 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 deliver a high-quality vaccine towards this virus to Australians.”

Dr Krishan Thiru, Pfizer Australia & New Zealand Medical Director

“In 2022, COVID-19 was one in every of Australia’s main causes of loss of life, behind coronary heart illness and dementia.6 With in the present day’s determination, an up to date vaccine will shortly change into obtainable that helps tackle a number of Omicron XBB-related sublineages, which presently account for the overwhelming majority of COVID-19 circumstances globally.”

“As COVID-19 is anticipated 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 attributable to Omicron XBB descendent sublineages which are antigenically distant from prior Omicron strains.”

The TGA’s determination was based mostly on the complete physique of earlier medical, 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 by means of the Nationwide Immunization Program (NIP).

The usage 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 normal practices throughout Australia.