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An Improved and High Throughput Respiratory Syncytial Virus RSV Micro-neutralization Assay
Published on: January 26, 2019
Respiratory syncytial virus prevention is finally here: An overview of safety
Ingrid Laemmle-Ruff1, Nigel W Crawford2
1MBBS, BMedSc, MPH, FAFPHM, FRACP, Public Health Physician and Paediatrician, Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Murdoch Children@s Research Institute, Melbourne, Vic; Paediatrician, Department of General Medicine, Royal Children@s Hospital, Melbourne, Vic.
Insights
New respiratory syncytial virus (RSV) prevention products in Australia, including vaccines and monoclonal antibodies, show good tolerability. Ongoing surveillance monitors rare potential safety signals for infants and older adults.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Recent approvals of respiratory syncytial virus (RSV) prevention products in Australia target high-risk groups: young infants and older adults.
- An RSV vaccine (Arexvy) is available privately for adults aged 60 and over, and nirsevimab monoclonal antibody programs for infants have begun in some Australian jurisdictions.
- These products are not yet part of the National Immunisation Program (NIP).
Purpose of the Study:
- To summarize safety data for recently approved RSV prevention products in Australia.
- To review safety information for adult RSV vaccines, maternal RSV vaccines, and infant monoclonal antibodies.
Main Methods:
- Review of clinical trial data for RSV prevention products.
- Analysis of safety profiles, including local and systemic reactions, and serious adverse events.
- Assessment of post-licensure surveillance data for safety signals.
Main Results:
- RSV prevention products were generally well tolerated in clinical trials.
- Most reported local and systemic reactions were mild to moderate and transient.
- Proportions of serious adverse events were low across the studied products.
Conclusions:
- Potential safety signals, though very rare, are under further assessment.
- These include the risk of preterm birth associated with the maternal RSV vaccine (Abrysvo) and Guillain-Barré syndrome (GBS) with RSV vaccines (Abrysvo, Arexvy) in older adults.
- Post-licensure surveillance is actively monitoring these adverse events of special interest.
Background:
A number of respiratory syncytial virus (RSV) prevention products have recently been approved in Australia. These products focus on highest risk groups, aiming to prevent RSV disease in young infants and older adults. While not currently included in the National Immunisation Program (NIP), an RSV vaccine (Arexvy, GlaxoSmithKline [GSK]) is available privately for adults ≥60 years, and some Australian jurisdictions have commenced RSV monoclonal antibody (nirsevimab) programs for infants in 2024.
Objective:
This article summarises safety data regarding RSV prevention products approved in Australia, including vaccines for adults ≥60 years, maternal vaccines and monoclonal antibodies for infants.
Discussion:
Clinical trial data found these products were largely well tolerated, with most local and systemic reactions being mild-moderate and short-lived. Proportions of serious adverse events were low. While very rare, potential safety signals being further assessed include risk of preterm birth following the maternal vaccine (Abrysvo, Pfizer) and Guillain-Barré syndrome (GBS) following RSV vaccines in older adults (Abrysvo and Arexvy). Close monitoring of these adverse events of special interest via post-licensure surveillance is underway.
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