WHO Approves Multi-Dose Maternal RSV Vaccine for Wider Access

The World Health Organization (WHO) has granted prequalification to a multi-dose vial version of the maternal respiratory syncytial virus (RSV) vaccine, known as RSVpreF, also marketed under the name ABRYSVO®. This decision is anticipated to improve the accessibility and affordability of this vital vaccine for newborns across various countries, especially those supported by Gavi, the Vaccine Alliance.

This development follows the prequalification of the single-dose form of the vaccine in March 2025. Subsequently, Gavi initiated a maternal RSV vaccination programme in July 2025. The introduction of the multi-dose presentation provides national health authorities with a more efficient option for implementing large-scale vaccination campaigns. With several doses contained in a single vial, healthcare providers can administer the vaccine through existing maternal healthcare frameworks.

Respiratory syncytial virus is a leading cause of severe respiratory ailments and pneumonia in young children, with approximately 3.6 million hospital admissions and an estimated 100,000 fatalities annually in children under five worldwide. Alarmingly, nearly half of these deaths occur in infants younger than six months, a time when their immune systems are still developing and they are particularly susceptible to rapid deterioration upon infection.

The burden of RSV is disproportionately felt in low- and middle-income countries, where about 97% of RSV-related deaths occur. Families in these regions may face challenges in reaching healthcare facilities or accessing essential treatments like oxygen and monitoring. In many instances, children succumb at home, underscoring the critical need for effective preventative measures during the early stages of life, particularly for communities located far from well-equipped medical services.

The maternal RSV vaccine operates by activating the immune system of the pregnant woman to produce antibodies, which are then transferred to the infant prior to birth, granting the newborn protective benefits for the first six months. WHO advises that the vaccine be administered during the third trimester, starting from the 28th week of pregnancy, to ensure sufficient time for antibody transfer through the placenta.

Developed with support from the Gates Foundation, this more affordable multi-dose option may facilitate the integration of maternal RSV vaccination into routine antenatal care and national immunisation programmes. The simpler mode of delivery could potentially lead to increased vaccination rates among pregnant women during scheduled health appointments, thereby affording early protection for their infants without necessitating an immediate injection after birth.

WHO recommends that each nation incorporate at least one of two strategies in their national health programmes for RSV prevention: vaccination with RSVpreF during pregnancy or administering the monoclonal antibody, nirsevimab, to infants. This flexibility allows countries to adopt the method that best suits their healthcare resources and local circumstances, with the new multi-dose vaccine presentation providing an additional strategy to combat severe illness, hospitalisation, and preventable deaths among the youngest populations worldwide.