Gavi welcomes WHO prequalification of multi-dose RSV maternal vaccine

Gavi, the Vaccine Alliance, has welcomed the World Health Organization’s (WHO) prequalification of a multi-dose vial presentation of an RSV maternal vaccine, describing it as a significant milestone that paves the way for introduction of the new vaccine in lower-income countries with Gavi support, according to a press release. The announcement was made in Geneva on 9 September 2026. The multi-dose presentation is expected to reach women during pregnancy through routine maternal immunisation programmes. More than 97% of RSV-related child deaths occur in lower-income countries. The prequalification strengthens the pathway toward Gavi-supported introduction of the vaccine.

Respiratory syncytial virus (RSV) is the leading infectious disease cause of severe pneumonia in young children globally and the second leading cause of infant mortality after malaria. Each year, RSV is responsible for an estimated 33 million lower respiratory tract infections, 3.6 million hospitalisations and more than 100,000 deaths among children under five. More than 97% of RSV-related deaths occur in low- and middle-income countries. The greatest burden falls on Africa. Almost all unvaccinated children in the world are infected by RSV by their second birthday.

Maternal immunisation offers an opportunity to protect infants during their most vulnerable first months of life, when the risk of severe RSV disease is highest. By vaccinating pregnant women, protective antibodies can be transferred to babies before birth, helping shield them from severe illness, hospitalisation and death. There is no specific treatment for RSV, making preventive strategies essential. An estimated 101,400 children under five die from RSV yearly worldwide, equivalent to five deaths every two minutes. All Gavi-eligible countries can now apply for Gavi support to introduce the vaccine in routine systems.

Emily Kobayashi, Director of Vaccine Programmes at Gavi, the Vaccine Alliance, commented on the development.

“The WHO prequalification of a multi-dose RSV maternal vaccine marks an important step towards ensuring that all children, regardless of where they are born, are protected at their very first breath against one of the world’s leading causes of infant hospitalisation and death,” she said.

She added that the multi-dose presentation creates the opportunity for Gavi-supported countries to deliver this protection through routine maternal immunisation programmes for the first time. Gavi’s Board had approved the establishment of an RSV maternal vaccine programme for Gavi-supported countries during the Alliance’s 2026–2030 strategic period in 2025. Introduction was conditional on the availability of a WHO prequalified multi-dose vial.

The prequalification milestone is also an important signal for the broader RSV market. Expansion of the range of presentations and products available helps create a more sustainable market and improves the long-term availability of affordable RSV prevention tools for countries with the highest disease burden. The Alliance continues to work closely with partners and key stakeholders to support country decision-making and successful vaccine introductions. Introduction of preventive strategies including maternal vaccination is key to reducing pneumonia cases, preventing infant deaths, decreasing hospitalisations and oxygen use. The step brings equitable access to life-saving RSV prevention closer for millions of families and children most at risk.