WHO prequalifies multi‑dose RSV vaccine vial, paving the way to protect more infants globally
Geneva, Switzerland – September 9, 2026
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 worldwide.
Context and Significance
RSV is the leading cause of acute lower respiratory infections in infants, accounting for a substantial share of childhood hospitalizations in sub‑Saharan Africa, South‑East Asia and Latin America. Maternal immunisation, which transfers protective antibodies from the mother to the fetus, has emerged as a promising strategy to shield newborns during the first six months of life, a period when infants are most vulnerable and vaccine options are limited.
In March 2025 WHO prequalified the single‑dose presentation of RSVpreF, and Gavi, the Vaccine Alliance, subsequently committed funding for a maternal RSV vaccine programme across 30 eligible countries. The multi‑dose vial, now prequalified, is designed to further reduce procurement costs and simplify delivery, especially in health systems that already use multi‑dose vials for other vaccines.
Details of the New Presentation
The multi‑dose vial contains 10 doses of the RSVpreF vaccine, each intended for a single maternal injection during the third trimester (28 weeks onward). The vial is formulated with the same adjuvant and antigenic composition as the single‑dose version, preserving the demonstrated safety and immunogenicity profile.
"The multi‑dose vial will make it easier for countries to integrate RSV maternal vaccination into existing antenatal care services without overburdening cold‑chain capacity," said Dr James Avoka Asamani, WHO Regional Director for the Western Pacific.
The vial is produced by GSK under strict Good Manufacturing Practice (GMP) standards and has undergone stability testing confirming a 24‑month shelf‑life at 2‑8 °C.
Implications for Global Health
The prequalification opens the door for Gavi‑supported procurement and for countries to negotiate lower prices through pooled purchasing mechanisms. WHO estimates that a 30 % price reduction could increase the number of eligible infants reached by up to 40 % in low‑resource settings.
The announcement also aligns with WHO’s broader strategy to reduce child mortality from vaccine‑preventable diseases, complementing recent efforts to prequalify new formulations of malaria and dengue vaccines.
Real‑World Voices
"This prequalification is a game‑changing step for protecting our most vulnerable children," said Dr Kate O’Brien, WHO Director of the Department of Immunisation, Vaccines and Biologicals. "Affordable, easy‑to‑administer vaccines are essential for achieving equitable health outcomes across all regions."
Health ministries in pilot countries, including Kenya, Bangladesh and Brazil, have expressed readiness to incorporate the multi‑dose RSV vaccine into their maternal health programmes once supply chains are established.
Next Steps
WHO will monitor post‑qualification data on vaccine uptake, safety and impact, and will provide technical assistance to countries developing implementation plans. Gavi is expected to release a financing framework for the vaccine later this year.
Sources
- WHO News Release, 9 September 2026.
- WHO Prequalification Database, 2025‑2026.
- Gavi Vaccine Investment Strategy 2025‑2030, 2025.
FIRAT Editorial Board
Institutional Research Desk · Foresight Institute of Research and Translation
The collective editorial and research translation board of FIRAT, synthesising peer-reviewed evidence, policy briefs, and division milestones across our seven foundational research pillars.
