AusVaxSafety publishes Australian-first safety data for Arexvy RSV vaccine

Australian-first active respiratory syncytial virus (RSV) vaccine safety data, published by AusVaxSafety in the Lancet Regional Health – Western Pacific, report low adverse event rates after Arexvy RSV vaccination.

Safety surveillance data from more than 2,000 Arexvy vaccine recipients between 29 February 2024 – when the vaccine became available in Australia through the private market for adults aged 60 years and older – and 27 September 2024 showed that over 63% experienced no side effects in the first three days after vaccination.

The most common adverse events experienced were local reactions (30%) – mainly pain, swelling and redness at the injection site – followed by fatigue (21%), muscle ache (myalgia; 13%) and headache (12%).

The level of impact on routine activities was low, with less than 5% of respondents reporting missing work, study or routine duties in the three days after vaccination. The proportion of respondents reporting medical attendance to a GP or hospital was low, at 0.4%.

Dr Lucy Deng, AusVaxSafety Clinical Lead, said, ‘This is the first post-marketing active surveillance data published in Australia for the Arexvy RSV vaccine and is 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,’ Dr Deng continued.

This paper is also the first to examine post-marketing safety data on Arexvy vaccine administered concomitantly (given on the same day) with other vaccines.

Those who received Arexvy concomitantly with another vaccine reported slightly higher rates of adverse events (43% vs 36% for Arexvy alone), impact on routine activities (7.3% vs 3.7%) and medical attendance (0.7% vs 0.4%) than those who received only the Arexvy vaccine.

The past 12 months have seen significant progress in RSV prevention in Australia through the approval of several new immunisation products designed to protect older adults, newborns and infants from severe RSV disease.

In addition to Arexvy, AusVaxSafety is actively monitoring the safety of Abrysvo – a new RSV vaccine for older adults and pregnant individuals – and Beyfortus (nirsevimab), a new long-acting, injectable monoclonal antibody product used to prevent severe RSV disease in infants. 

‘Our active surveillance activities ensure that these new RSV prevention products are performing as safely as we expect them to in real-world conditions,’ Dr Deng said.

To collect data, AusVaxSafety distributes a short online survey via SMS or email to individuals – or their parent/carer – who received an RSV prevention product at a participating AusVaxSafety site, allowing participants to report any adverse events they may have experienced following immunisation.

AusVaxSafety epidemiologists and immunisation experts analyse and monitor de-identified data from completed surveys to ensure the immunisation is performing as safely as expected.

AusVaxSafety will continue to monitor RSV immunisation products to ensure their ongoing safety. Safety data are updated on the AusVaxSafety website monthly.

Read the paper

View the latest RSV AusVaxSafety vaccine safety data