Respiratory Syncytial Virus – (RSV-mAb [Nirsevimab])
Recommended Age Range:
Birth to 24 months (during RSV season)
Common Side Effects:
Rash, fever, injection site reactions
Research & Testing History:
Phase 2/3 trials showed ~70–75% efficacy in preventing RSV-related illness in infants.
Use History:
FDA approved in July 2023
Trial Size:
Multi-phase, randomized placebo study of ~4,000 pregnant mothers & infants
Years on Schedule:
<1 year
Known Safety Concerns:
No major hypersensitivity reactions reported
Ingredients:
Nirsevimab-alip (monoclonal antibody), histidine, histidine hydrochloride monohydrate, sucrose, polysorbate 80, water for injection.
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