First Arexvy safety data released

The first Australian safety data on respiratory syncytial virus (RSV) vaccine, Arexvy, for patients aged 60 years and older has found low rates of reported adverse events.
 
In January last year, the Therapeutic Goods Administration (TGA) approved Arexvy for older Australians, a move described at the time as a ‘turning point’ for public health.
 
One year on, a first-of-its-kind analysis of safety surveillance data has been released, covering more than 2000 Arexvy vaccine recipients between 29 February 2024 and 27 September 2024.
 
Researchers from AusVaxSafety, which is led by the National Centre for Immunisation Research and Surveillance, tracked adverse events following immunisation through an online survey sent to vaccinees three days post-vaccination.
 
They examined the proportion of respondents reporting local adverse events, systemic symptoms such as fever, chills and fatigue, gastrointestinal symptoms, as well as those seeking medical attention, and the impact on daily activities.
 
Of the 2013 respondents aged 60 years or older who received Arexvy during that timeframe, 63% experienced no side effects in the first three days after vaccination. 
 
The most common adverse events experienced were local reactions, mainly pain, swelling and redness at the injection site (30%), fatigue (21%), myalgia (13%), and headache (12%).  
 
Less than 5% of respondents reported missing work, study or routine duties in the three days after vaccination, and the proportion of respondents reporting medical attendance to a GP or hospital was 0.4%. 
 
AusVaxSafety Clinical Lead Dr Lucy Deng said the data is a ‘testament to Australia’s commitment to ongoing vaccine safety through robust monitoring’.
 
‘Reassuringly, the rates of adverse events reported to AusVaxSafety following Arexvy RSV vaccination are consistent with expectations from clinical trial data and other international surveillance activities,’ she said.
 
‘Our active surveillance activities ensure that these new RSV prevention products are performing as safely as we expect them to in real-world conditions.’
 
The safety data comes at a time when RSV cases continue to skyrocket across Australia, with a record-breaking 175,918 reported last year.
 
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Arexvy respiratory syncytial virus RSV vaccination