Pfizer-BioNTech COVID vaccine gets green light: Will it tackle the emerging virus variants?

Pharma News: Pfizer Australia and BioNTech SE have announced that the Therapeutic Goods Administration (TGA) has granted authorisation for the XBB.1.5-adapted monovalent COVID-19 vaccine, known as COMIRNATY Omicron XBB.1.5, for individuals aged 5 years and older.

Dr Krishan Thiru, Pfizer Australia & New Zealand Medical Director, expressed enthusiasm for the TGA’s decision, stating, “We welcome the TGA’s decision and commend them for their careful assessment of the latest version of Comirnaty. This decision reaffirms our commitment to bring a high-quality vaccine against this virus to Australians.”

Associate Professor James Trauer, Head of Epidemiological Modelling at Monash University, pointed to the newer variant.

“EG.5.1 [Eris] is currently the fastest growing variant globally by proportion of total SARS-CoV-2 sequences,” he explained. “These XBB sublineages, such as XBB.1.5, have become the dominant variants across the globe over the course of the last year.”

Professor Ugur Sahin, CEO and Co-founder of BioNTech, stressed the importance of adapting to the evolving landscape of the virus.

“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 better matched to relevant circulating virus variants or sublineages to people worldwide,” Professor Sahin said.

“The new variant-adapted monovalent vaccine aims to further improve protection against severe illness and hospitalisation caused by Omicron XBB descendent sublineages that are antigenically distant from prior Omicron strains.”

Dr Stuart Turville, Associate Professor of Immunovirology and Pathogenesis Program at the Kirby Institute, UNSW Australia, highlighted the similarities between the newly identified variant and the existing XBB.1.5 variant.

“The way the [EG.5.1] virus targets cells is similar to that observed for XBB.1.5, so there is no evidence that this variant will infect in a manner that is significantly divergent to XBB.1.5,” he clarified.

The TGA’s decision to authorise the XBB.1.5-adapted monovalent COVID-19 vaccine was based on a review of previous clinical, non-clinical, and real-world evidence affirming the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines.

In light of this milestone, the Australian Technical Advisory Group on Immunization (ATAGI) will continue to guide the Minister for Health and Aged Care on the strategic administration of vaccines available in Australia, including those accessible through the National Immunization Program (NIP).

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