WHO prequalifies multi-dose maternal RSV vaccine to expand infant protection

SWITZERLAND—The World Health Organization (WHO) has prequalified a multi-dose vial presentation of the maternal respiratory syncytial virus (RSV) vaccine RSVpreF (ABRYSVO®), paving the way for wider access to vaccination that can protect infants against severe RSV disease.

The new presentation is expected to reduce vaccination costs and simplify delivery, particularly in low- and middle-income countries supported by Gavi, the Vaccine Alliance.

The decision follows WHO’s prequalification of the vaccine’s single dose presentation in March 2025 and Gavi’s decision in July 2025 to establish a maternal RSV vaccine programme.

Protecting infants from severe RSV disease

RSV remains a major cause of respiratory illness and hospitalisation among young children.

The virus is estimated to cause more than 3.6 million hospitalisations and about 100,000 deaths among children under five each year.

Infants younger than six months account for almost half of these deaths.

This age group is the primary target of maternal RSV vaccination because newborns can receive protective antibodies from their mothers before birth.

The burden is particularly high in low- and middle-income countries, which account for about 97% of RSV deaths.

Limited access to supportive medical care can increase the risk of severe disease and death. In some cases, children die at home before they can reach a health facility.

Lower cost vaccine presentation

Developed with support from the Gates Foundation, the multi-dose vial presentation is intended to make large-scale introduction of maternal RSV vaccination more practical for countries.

The lower-cost format can help national immunization programs plan vaccine procurement and delivery more efficiently while expanding access to pregnant women.

RSVpreF protects infants during their first six months of life by stimulating the mother to produce antibodies that are transferred to the baby before birth.

This provides protection during a period when infants remain particularly vulnerable to severe RSV infection.

WHO recommends maternal vaccination

To reduce the global burden of severe RSV disease, WHO recommends that countries introduce either maternal RSV vaccination with RSVpreF or the monoclonal antibody nirsevimab into their national immunisation programmes.

For maternal vaccination, WHO recommends administering RSVpreF to pregnant women during the third trimester, from 28 weeks of pregnancy onwards.

Vaccination at this stage is intended to support the transfer of sufficient antibodies from mother to baby before birth.

The multi dose presentation adds to the available options for countries seeking to introduce maternal RSV vaccination and expand protection for newborns and young infants.

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