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An Improved and High Throughput Respiratory Syncytial Virus RSV Micro-neutralization Assay
Published on: January 26, 2019
ACTIVE POST-MARKETING SAFETY SURVEILLANCE OF NIRSEVIMAB ADMINISTERED TO CHILDREN IN WESTERN AUSTRALIA, APRIL-JULY
Dale Carcione1, Phoebe Spencer1, Grace Pettigrew1
1From the Communicable Disease Control Directorate, Western Australia Department of Health, Perth, Western Australia, Australia.
Insights
Nirsevimab, a monoclonal antibody for respiratory syncytial virus, showed a low incidence of adverse events in children. Post-immunization monitoring via online surveys indicated no severe reactions requiring hospitalization.
Area of Science:
- Pediatrics
- Immunology
- Public Health
Background:
- Respiratory Syncytial Virus (RSV) is a major cause of lower respiratory tract infections in infants.
- Nirsevimab is a long-acting monoclonal antibody developed for RSV prevention.
- Monitoring adverse events following immunization (AEFI) is crucial for vaccine safety surveillance.
Purpose of the Study:
- To assess the safety and tolerability of nirsevimab in infants through real-world data.
- To monitor for any adverse events following immunization (AEFI) in children receiving nirsevimab.
Main Methods:
- Parents of children who received nirsevimab were sent a link to an online survey.
- The survey aimed to capture self-reported adverse events post-immunization.
- Response rates and reported reactions were analyzed for nirsevimab alone and in combination with other vaccines.
Main Results:
- Out of 4340 parents who received the survey link, 1195 (27.5%) responded.
- 47 out of 410 children (11.4%) receiving nirsevimab alone reported a reaction.
- 230 out of 785 children (29.3%) receiving nirsevimab with other vaccines reported a reaction.
Conclusions:
- Nirsevimab demonstrated a favorable safety profile in a real-world setting.
- The majority of reported reactions were mild and did not require inpatient care.
- Online surveys are a viable method for post-immunization safety monitoring.
Abstract:
Children receiving nirsevimab were texted a link to an online survey to monitor adverse events following immunization. Total of 4340 parents received the link, which 1195 (27.5%) responded. Forty-seven (11.4%) of 410 children who received nirsevimab alone and 230 (29.3%) of 785 children who received nirsevimab coadministered reported any reaction. No adverse events required in-patient care or had ongoing sequelae.
