GSK nabs label expansion for RSV vaccine

Coinciding with World Immunisation Week (24-30 April), GSK has secured TGA approval for its respiratory syncytial virus (RSV) vaccine, marking the first approval for adults aged 50-59 years who are at heightened risk of the disease.

Arexvy (adjuvanted RSVPreF3OA) was Australia’s first RSV vaccine for adults aged 60 years and above. Shortly thereafter, Pfizer secured its own regulatory approval for Abrysvo for this patient cohort in addition to an indication in pregnant women.

“RSV is generally viewed as a virus that largely affects young children, however, it can have a very significant impact in adults over 50, particularly those with existing medical conditions,” remarked Professor Charlotte Hespe AM, Head of General Practice and Primary Care Research at the School of Medicine, Sydney. “Having a vaccine indicated for adults 50 through 59 years of age who are at increased risk for RSV provides Australian clinicians with an opportunity to address this important public health priority.”

In 2024, Australia saw a surge in RSV cases, with a total of 175,786 reported nationwide. Of these, more than 41,000 were in adults aged 50 and over, as per data from the National Notifiable Diseases Surveillance System. Between 2016 and 2019, RSV led to over 115,000 hospitalisations across all age groups, highlighting the significant burden the virus places on the healthcare system.

“For adults over 50 who live with the challenges of chronic health diseases, like COPD and asthma, RSV can be extremely serious,” noted Mark Brooke, CEO of Lung Foundation Australia. “Supporting this community by providing potential options against RSV for suitable patients is great news.”

A recent study evaluating Arexvy’s immune response and safety in 50-59 year olds demonstrated noninferior immunogenicity compared to those aged 60 and above, where efficacy was previously established. The safety profile in the 50-59 age group aligned with findings in older adults.

Administered as a single dose, Arexvy can be given alongside any influenza vaccine during the same visit. In addition to respiratory chronic conditions, diabetes and heart failure also place individuals at higher risk of RSV.

“Ensuring access to vaccines against our most challenging viruses remains a priority at GSK, and expanding the availability of our RSV vaccine is a vital part of our commitment,” said Dr Alan Paul, Executive Country Medical Director at GSK Australia.

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