Nöbetçi Eczaneler
The World Health Organization announced on 9 September 2026 that it had prequalified the multi-dose vial presentation of the maternal RSV vaccine RSVpreF. WHO said the decision could make large-scale introduction more affordable and easier to organise, particularly in countries eligible for Gavi support.
Decision expands an earlier prequalification
WHO prequalified the single-dose presentation of the same vaccine in March 2025. The multi-dose decision followed Gavi’s July 2025 move to establish a maternal RSV vaccination programme, creating an additional format for international procurement and national delivery planning.
Prequalification means the product has been assessed against WHO requirements for quality, safety and efficacy. It is an important reference for United Nations agencies and international purchasing programmes, but it does not automatically place the vaccine in every national immunisation schedule.
Protection is transferred before birth
The vaccine is administered during pregnancy so that antibodies produced by the mother can pass to the baby before birth. The purpose is to protect infants during their first six months, when the risk of severe respiratory syncytial virus disease is particularly high.
WHO advises countries to introduce either maternal vaccination with RSVpreF or the long-acting monoclonal antibody nirsevimab. National authorities decide which approach fits their disease burden, health-system capacity, regulatory process and delivery conditions.
RSV burden is concentrated in lower-income settings
WHO estimates that RSV causes more than 3.6 million hospital admissions and about 100,000 deaths among children under five each year. Around 97 per cent of those deaths occur in low- and middle-income countries, and a substantial share affects babies younger than six months.
Multi-dose vials may simplify high-volume delivery, but countries must still plan cold-chain capacity, staff training, vial use and clinical protocols. WHO recommends maternal vaccination from the 28th week of pregnancy where that option is adopted.