The World Health Organization (WHO) has prequalified the multi-dose vial presentation of the maternal respiratory syncytial virus (RSV) vaccine, RSVpreF (ABRYSVO®), marking a major step toward protecting more infants from severe respiratory illness and pneumonia globally. The new presentation is expected to make maternal RSV vaccination more affordable and easier to deliver, particularly in countries supported by Gavi, the Vaccine Alliance. 

The decision builds on WHO's prequalification of the vaccine's single-dose presentation in March 2025 and Gavi's subsequent decision in July 2025 to establish a maternal RSV vaccine programme. This is aimed at protecting newborns and young infants from one of the leading causes of respiratory illness and hospitalization worldwide.  

Each year, RSV is estimated to cause more than 3.6 million hospitalizations and approximately 100 000 deaths among children under 5 years of age. Almost half of these deaths occur in infants younger than 6 months of age, the population protected through maternal immunization. Roughly 97% of RSV deaths occur in low- and middle-income countries where there is limited access to supportive medical care. In many cases, children die at home before reaching a health facility.