WHO Approves Multi-Dose RSV Vaccine for Maternal Use

The World Health Organization (WHO) has announced the prequalification of a multi-dose vial presentation of the maternal respiratory syncytial virus (RSV) vaccine, known as RSVpreF (ABRYSVO). This significant advancement is aimed at improving the protection of infants against severe respiratory illnesses and pneumonia on a global scale. By facilitating maternal vaccination, the WHO hopes to reduce the incidence of RSV-related complications in newborns.

Historically, RSV has been a leading cause of respiratory illness in young children, resulting in approximately 100,000 deaths and over 3.6 million hospitalizations each year among children under five. Notably, half of these fatalities occur in infants younger than six months. The new multi-dose presentation is expected to enhance the affordability and delivery of the maternal RSV vaccine, particularly in countries supported by Gavi, the Vaccine Alliance, which focuses on improving access to vaccines in low-income regions.

The maternal RSV vaccine is designed to transfer protective antibodies from mothers to their infants before birth, safeguarding them during their crucial first six months of life. This prequalification builds on the WHO's earlier approval of a single-dose version of the vaccine in March 2025, followed by Gavi's decision in July 2025 to initiate a maternal RSV vaccination program. These steps reflect a concerted effort to combat the high mortality rates associated with RSV in vulnerable populations.

The implications of this development are significant, particularly for low and middle-income countries where access to medical care is limited. With 97 percent of RSV-related deaths in infants occurring in these regions, the multi-dose vaccine could dramatically improve health outcomes. By making the vaccine more accessible, it is anticipated that maternal immunization will lead to a decrease in hospitalizations and deaths caused by RSV.

Looking ahead, the WHO and Gavi are expected to continue their collaboration to roll out the maternal RSV vaccination program. As health authorities prepare for implementation, further studies and monitoring will be essential to ensure the vaccine's effectiveness and safety in diverse populations. The global health community remains hopeful that this initiative will significantly reduce the burden of RSV among infants worldwide.