Short-term safety evaluation of Nirsevimab injection: a prospective study
10.3760/cma.j.cn113903-20250824-00450
- VernacularTitle:尼塞韦单抗注射的短期安全性评估：前瞻性研究
- Author:
Pengxiang ZHOU
1
;
Linghui LI
;
Wei ZHOU
;
Meihua PIAO
;
Tongyan HAN
Author Information
1. 北京大学第三医院药学部，北京 100191
- Publication Type:Journal Article
- Keywords:
Respiratory syncytial virus;
Nirsevimab;
Safety
- From:
Chinese Journal of Perinatal Medicine
2025;28(12):1057-1061
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the short-term safety of Nirsevimab injection for preventing respiratory syncytial virus infections in infants through a physician-nurse-pharmacist collaborative model.Methods:This prospective observational study enrolled infants receiving single-dose Nirsevimab at Peking University Third Hospital from September 2024 to August 2025. A multidisciplinary team comprising pediatricians, nurses, pharmacists, and obstetricians was established to develop standardized protocols for medication management, injection procedures, follow-up processes, and safety assessment forms. Descriptive statistics analyzed on-site observations within 30 minutes post-injection and all adverse events, with causality assessment conducted.Results:Among 331 participants [171 males (51.7%), 160 females (48.3%)], 225 (68.0%) received outpatient injections and 106 (32.0%) inpatient injections. Successful administration was achieved in 330 cases (99.7%), including 207 (62.7%) receiving 50 mg/vial and 123 (37.3%) receiving 100 mg/vial formulations; one child (3 years 11 months, 19.0 kg) received two 100 mg doses. During the 30-minute observation, 11 cases (3.3%) experienced adverse events, all presenting as injection site erythema following 100 mg/vial administration, with no systemic or serious adverse events observed. All symptoms resolved spontaneously within 30 minutes. Multidisciplinary review suggested potential associations with insufficient rewarming time, larger injection volumes, or post-injection compression pressure.Conclusion:Nirsevimab demonstrated favorable short-term safety profiles in Chinese infants following single-dose administration, with feasible multidisciplinary standardized protocols, though larger sample sizes and extended follow-up are warranted for monitoring medium-to-long-term safety and special populations.
