TGA approves RSV vaccine for Australians aged 60+

The Therapeutics Goods Administration (TGA) has announced its approval of GSK’s AREXVY vaccine to protect against lower airway disease caused by respiratory syncytial virus (RSV) in adults aged 60 years and over. AREXVY is the first RSV vaccine to be approved for use in Australia.

RSV is a common and contagious respiratory virus, predominantly spread by inhaling airborne droplets from the infected or through contact with contaminated surfaces, which can cause cold- and flu-like symptoms. It is often considered as an illness that mainly affects children, but RSV can also cause serious health complications including pneumonia, respiratory failure and even death in older adults, particularly those with chronic medical conditions such as asthma, diabetes, chronic obstructive pulmonary disease (COPD) and congestive heart failure.

“Most people view RSV as an illness that mainly affects children, and its impact on older adults, especially for those with underlying medical conditions, has fallen under the radar,” said Professor Robert Booy, an infectious diseases expert at The University of Sydney Clinical School & Children’s Hospital at Westmead. Indeed, cases of RSV were only officially counted in Australia from 2021, so there are still gaps in fully understanding how common the disease is and what impact it has on the Australian population.

AREXVY, which has already been approved for use in the UK, the European Union, the US, Canada and Japan, is a protein-based vaccine given as a single dose. The TGA registration of the vaccine is based on the results of GSK’s international phase III clinical trial, which compared AREXVY with placebo in almost 25,000 people aged 60 years or older.

“The availability of an RSV vaccine for adults aged 60 and over is the result of collaboration across academia, industry and research centres,” said Dr Alan Paul, Executive Country Medical Director, GSK Australia. “I am excited to see this innovation now become available for older adults in Australia, including those with underlying health conditions, who carry a substantial burden of disease with RSV infection.”

“Until now, RSV did not have a vaccine or specific treatment for older adults,” Booy concluded. “This is a real step forward for public health and a turning point in our effort to reduce the impact of RSV.”

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