Beyfortus® (nirsevimab-alip) 50 mg and 100 mg Injection Efficacy & Safety Profile Overview
Studied across a broad range of infant populations entering their first RSV season¹
![Studied across a broad range of infant populations entering their first RSV season overview graph](https://cdn.prod.accelerator.sanofi/beyfortus/images/figure-trial-table.webp)
Trial 04 continued monitoring for the primary cohort and an additional 1,522 subjects to include all subjects.⁴
Proven strong and consistent efficacy against RSV disease¹
Trial 04 (Primary Cohort): healthy term and late preterm infants (≥35 wGA)1*†‡
Medically attended (MA) includes all healthcare provider visits such as physician’s office, urgent care, emergency room, and hospitalizations
![74.9% RRR incidence of MA RSV-LRTI (inpatient or outpatient)](https://cdn.prod.accelerator.sanofi/beyfortus/images/figure-trial-vs-placebo.webp)
Proven strong and consistent efficacy against RSV disease¹
Trial 03: healthy preterm infants (≥29 to <35 wGA)1*†
Medically attended (MA) includes all healthcare provider visits such as physician’s office, urgent care, emergency room, and hospitalizations
![70.1% RRR incidence of MA RSV-LRTI (inpatient or outpatient)](https://cdn.prod.accelerator.sanofi/beyfortus/images/trial3-placebo.webp)
Beyfortus demonstrated consistent safety profile across multiple infant cohorts¹˒²˒⁵˒⁹
- The Beyfortus group included 1,998 healthy term and late preterm infants (≥35 wGA) and 572 preterm infants (≥29 to <35 wGA)
- Adverse reactions were reported in 1.2% of infants who received Beyfortus; most (97%) of adverse reactions were mild to moderate in severity
Most Common Adverse Reactions Reported at an Incidence Higher Than Placebo in the Safety Population (Trial 04 and Trial 03)1*
Adverse reaction | Beyfortus N=2,570 | Placebo N=1,284 |
---|---|---|
Rash† (occurring within 14 days post dose) | 0.9% | 0.6% |
Injection Site Reaction‡ (occurring within 7 days post dose) | 0.3% | 0.0% |
Safety studied in infants and children at higher risk for severe RSV disease¹
First RSV season¹: infants born at <35 wGA and infants with CLD of prematurity and hemodynamically significant CHD
- Adverse reactions reported among Trial 05 infants who received Beyfortus in their first RSV season were similar to those reported in infants who received Beyfortus in Trials 03 and 04
Second RSV season¹: children up to 24 months with CLD of prematurity and hemodynamically significant CHD
- The safety profile of Beyfortus in these children during their second RSV season was consistent with the safety profile of Beyfortus observed during their first RSV season
![Order Beyfortus Packaging Image](https://cdn.prod.accelerator.sanofi/beyfortus/images/beyfortus-packaging.webp)
Pre-filled Syringe for Convenient Administration¹
![antibody](https://cdn.prod.accelerator.sanofi/beyfortus/images/check.webp)
Cost and Coverage With Beyfortus
![Beyfortus mAb image](https://cdn.prod.accelerator.sanofi/beyfortus/images/antibody.webp)