Arexvy™ and Abrysvo™ are the first FDA-approved vaccines for respiratory syncytial virus (RSV) targeting two patient populations at greatest risk: older adults and infants.
The two vaccines gained approval after just one RSV season of study, given the urgency to provide protection to these vulnerable populations. However, both sponsors are required to conduct further studies and surveillance to provide additional evidence of their effectiveness and evaluate their potential risks.
This report explores:
- Disease and competitive landscape
- Regulatory strategy (e.g., which pathways to pursue in key markets)
- Key areas of regulatory focus, such as safety concerns, pharmacovigilance, use in specific populations and effectiveness
- Outstanding safety and efficacy concerns
