WHO prequalifies multi-dose RSV vaccine to expand global infant protection

The World Health Organization (WHO) has prequalified the multi-dose vial presentation of the maternal respiratory syncytial virus (RSV) vaccine, RSVpreF (ABRYSVO®). This development is intended to increase the affordability and ease of delivery of maternal RSV vaccinations, particularly in countries supported by Gavi, the Vaccine Alliance.

RSV is a major cause of respiratory illness, causing an estimated 3.6 million hospitalizations and approximately 100,000 deaths among children under five years of age annually. Nearly half of these deaths occur in infants younger than six months, the group targeted by maternal immunization which transfers antibodies from mother to baby before birth. Approximately 97% of RSV-related deaths occur in low- and middle-income countries.

In a separate study published in JAMA Internal Medicine, research involving over 597,000 Medicare participants analyzed the effectiveness of RSV vaccines in nursing home residents during the 2023/2024 season. The study found a 73% overall efficacy against RSV-related hospitalizations. Protection varied by age, with a 60% efficacy rate for those aged 65–74 and a 75% rate for those aged 75 and older.