WHO Approves Multi-Dose RSV Vaccine Vial to Widen Infant Protection

Geneva (GNP): The World Health Organization (WHO) has prequalified the multi-dose vial presentation of the maternal respiratory syncytial virus (RSV) vaccine, RSVpreF, marking a significant step toward protecting more infants worldwide from severe respiratory illness and pneumonia.

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. It builds on the WHO’s earlier prequalification of the vaccine’s single-dose presentation in March 2025, as well as Gavi’s subsequent decision in July 2025 to establish a dedicated maternal RSV vaccine programme aimed at protecting newborns and young infants.

RSV remains one of the leading causes of respiratory illness and hospitalisation among young children globally. The WHO estimates that the virus causes more than 3.6 million hospitalisations and approximately 100,000 deaths each year among children under five years of age.

Close to half of these deaths occur in infants younger than six months, the age group specifically protected through maternal immunisation. The vast majority of RSV-related deaths, roughly 97%, occur in low- and middle-income countries, where access to supportive medical care remains limited and children in many cases die at home before reaching a health facility.

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Developed with support from the Gates Foundation, the lower-cost multi-dose vial is designed to improve the feasibility of large-scale vaccine introductions, giving countries greater flexibility to plan and deliver the vaccine through their national immunisation programmes.

The maternal RSV vaccine works by transferring protective antibodies from mother to baby before birth, shielding infants during their first six months of life, a period when they are most vulnerable to severe RSV disease.

To reduce the global burden of RSV, the WHO recommends that all countries introduce either the maternal vaccine, RSVpreF, or the monoclonal antibody nirsevimab into their national immunisation programmes. For the maternal vaccine specifically, the WHO recommends administration during the third trimester of pregnancy, from week 28 onwards, in order to optimise the transfer of antibodies to the baby before delivery.