WHO prequalifies multi-dose RSV vaccine vial, paving the way to protecting more infants globally

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.

Developed with support from the Gates Foundation, the lower-cost multi-dose vial presentation of the maternal RSV vaccine will improve the feasibility of countries to plan and deliver large-scale introductions of the vaccine into their national immunization programmes.

The maternal RSV vaccine is designed to protect infants during their first six months of life through the transfer antibodies from the mother to the baby before birth.

To reduce the burden of service RSV disease globally, WHO recommends that all countries introduce either the maternal vaccine, RSVpreF, or the monoclonal antibody, nirsevimab into their national programmes. WHO recommends that the maternal vaccine, RSVpreF, be given to pregnant women during the third trimester of pregnancy, from week 28 onwards, to optimize for the adequate transfer of antibodies to their baby. 

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