Geneva, Switzerland – September 10, 2026

A four‑year‑old maternal respiratory syncytial virus (RSV) vaccine, RSVpreF (ABRYSVO®), has received WHO prequalification in a multi‑dose vial format, a move expected to lower costs and simplify delivery in low‑ and middle‑income countries.

Why this matters now

Maternal immunisation protects infants during the first six months of life through the transfer of antibodies across the placenta. The original single‑dose presentation, prequalified in March 2025, has already been introduced in several Gavi‑supported nations. However, the high per‑dose cost and cold‑chain requirements have limited broader rollout. A multi‑dose vial reduces the price per dose and eases logistics, allowing health ministries to vaccinate larger cohorts with existing infrastructure.

Details of the prequalification

WHO evaluated the vaccine’s quality, safety, and efficacy based on data from Phase III trials involving over 30 000 pregnant women across Africa and Asia. The vaccine demonstrated a 71 % efficacy against severe RSV disease in infants up to six months old and a favorable safety profile with no serious adverse events attributed to the vaccine.

The multi‑dose vial contains 10 ml of liquid, each dose delivering 0.5 ml of vaccine. This format is compatible with existing cold‑chain equipment used for other maternal vaccines, such as tetanus‑containing vaccines.

Gavi’s role and financing

Gavi has pledged to support the introduction of the multi‑dose RSV vaccine in eligible countries, contingent on the vaccine’s affordability and WHO’s recommendation. The alliance’s investment case projects that vaccinating 5 million pregnant women annually could prevent an estimated 12 000 infant deaths each year.

Implications for global health

The prequalification expands the toolkit for reducing childhood pneumonia, the leading cause of death in children under five worldwide. By protecting infants before birth, the vaccine complements existing interventions such as palivizumab monoclonal antibodies and non‑pharmaceutical measures like hand‑washing and breastfeeding promotion.

Health ministries are encouraged to integrate the RSV vaccine into routine antenatal care schedules, targeting pregnant women at 28 weeks gestation or later to maximise antibody transfer.

Sources

• WHO News Release, 9 September 2026, "WHO prequalifies multi‑dose RSV vaccine vial, paving the way to protecting more infants globally".
• Gavi Press Release, 13 March 2025, "Gavi welcomes first‑ever prequalification of a maternal RSV vaccine".
• Clinical trial data, Phase III RSVpreF study, The Lancet, 2025.
• WHO pre‑qualification dossier, 2025‑2026.