The World Health Organization has prequalified a multi-dose vial presentation of the maternal respiratory syncytial virus vaccine, RSVpreF, marketed as ABRYSVO, according to an official announcement from the organization. The decision is designed to make maternal immunization against respiratory illness and pneumonia significantly more affordable and easier to distribute globally.
Global Impact and Access Goals for Maternal RSV Vaccination
According to the World Health Organization, the new multi-dose vial presentation paves the way for wider distribution, particularly in nations supported by Gavi, the Vaccine Alliance. This regulatory milestone follows the World Health Organization’s March 2025 prequalification of the vaccine’s single-dose presentation. Subsequently, Gavi established a maternal respiratory syncytial virus vaccine program in July 2025 to shield newborns and young infants from respiratory illness and hospitalization.
Respiratory syncytial virus accounts for more than 3.6 million hospitalizations and roughly 100,000 deaths annually among children under five years of age worldwide, based on World Health Organization estimates. Almost half of these fatalities occur in infants younger than six months old, the population protected through maternal immunization. Furthermore, roughly 97% of respiratory syncytial virus deaths happen in low- and middle-income countries where access to supportive medical care remains limited, often resulting in children dying at home before reaching a health facility.
Distribution Strategy and Clinical Recommendations
The lower-cost multi-dose formulation was developed with support from the Gates Foundation. This economic adjustment aims to improve the feasibility for countries to plan and deliver large-scale introductions of the vaccine into their national immunization programmes.
By passing antibodies from the mother to her baby prior to delivery, the maternal vaccine aims to safeguard infants throughout their initial six months of life. To help reduce the worldwide impact of the illness, the World Health Organization advises every nation to incorporate either the RSVpreF maternal vaccine or the nirsevimab monoclonal antibody into their national immunization schedules.
Clinically, the World Health Organization advises administering the RSVpreF maternal vaccine during the third trimester of pregnancy, specifically from week 28 onwards. This timing optimizes for the adequate transfer of antibodies to their baby.
Worth a look