Gavi welcomes prequalification of multi-dose RSV maternal vaccine to protect infants

  • WHO prequalification of a multi-dose RSV maternal vaccine marks a major step towards protecting newborns and infants from one of the leading causes of severe respiratory illness, hospitalisation and death worldwide.

  • The new vaccine is expected to reach women during pregnancy through routine maternal immunisation programmes in lower-income countries, where more than 97% of RSV-related child deaths occur.

  • The milestone strengthens the pathway towards Gavi-supported introduction, helping bring equitable access to life-saving RSV prevention closer for millions of families and children most at risk.

Geneva, 9 September 2026 – Gavi, the Vaccine Alliance welcomes the World Health Organization’s (WHO) prequalification of a multi-dose vial presentation of an RSV maternal vaccine, a significant milestone, that paves the way for introduction of this new protective vaccine in lower income countries, with Gavi support.

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, with the greatest burden falling on Africa.

Maternal immunisation offers a powerful 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.

Commenting on the development, Emily Kobayashi the Director of Vaccine Programmes, at Gavi, the Vaccine Alliance, said:

"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. This multi-dose presentation now creates the opportunity for Gavi-supported countries to deliver this protection through routine maternal immunisation programmes for the first time."

The latest 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.

Facts and figures

  • RSV is transmitted via infectious respiratory particles through the air from one infected person to another one. Almost all unvaccinated children in the world are infected by RSV by their second birthday. While most have mild illness, some develop bronchiolitis and pneumonia as a result.
  • Annually, RSV is responsible for 33 million cases of lower respiratory tract infections and 3.6 million hospitalisations in children under five years old, primarily during their first year of life.
  • RSV is the second leading cause of infant mortality after malaria, with an estimated 101,400 deaths yearly of children under five years old worldwide, with an estimation of 5 deaths every 2 minutes.
  • More than 97% of these deaths occur in lower- and middle-income countries, and the greatest mortality burden is in Africa.
  • As there is no specific treatment for RSV, introduction of preventive strategies in countries including maternal vaccination to protect infants is key to significantly reducing pneumonia cases, preventing infant deaths, decreasing hospitalizations and oxygen use.
  • All Gavi-eligible countries can now apply for Gavi support to introduce this vaccine in routine systems
  • While Gavi's Board had in 2025 approved the establishment of an RSV maternal vaccine programme for Gavi-supported countries during the Alliance's 2026–2030 strategic period introduction was conditional on the availability and WHO prequalified multi-dose vial.

Notes to Editors

About Gavi, the Vaccine Alliance

Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate more than half the world’s children against some of the world’s deadliest diseases. The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Gates Foundation and other private sector partners. View the full list of donor governments and other leading organisations that fund Gavi’s work here.

Since its inception in 2000, Gavi has helped to immunise a whole generation – over 1.2 billion children – and prevented more than 20.6 million future deaths, helping to halve child mortality in 78 lower‑income countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningococcal and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation, above all the zero-dose children who have not received even a single vaccine shot. The Vaccine Alliance employs innovative finance and the latest technology – from drones to biometrics – to save lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency. Learn more at www.gavi.org and connect with us on Bluesky, Facebook, Instagram, LinkedIn, TikTok, X and YouTube.

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