RSV vaccines | NITAG RESOURCE CENTER

Overview

In September 2024, WHO issued recommendations about two primary strategies for preventing severe Respiratory Syncytial Virus (RSV) disease in infants. The first is maternal vaccination with a single dose of a vaccine consisting of the stabilized prefusion conformation of the fusion protein of RSV (pre-F RSV vaccine) to pregnant women in their third trimester to protect their newborns through transplacental antibody transfer; this approach aims to reduce the incidence of severe RSV infections in infants during their first months of life. The second is the administration of a single dose of a long-acting monoclonal antibody (mAb) at birth or just before the RSV season to offer direct protection against the virus for approximately six months.

In March 2025, WHO prequalified the first maternal Pre-F RSV vaccine (ABRYSVO®, Pfizer). This prequalification facilitates the vaccine's procurement by UN agencies and supports its inclusion in global immunization programs. At the time that WHO issued recommendations, only a single long-acting mAb (nirsevimab) had received market authorization. A second long-acting mAb (clesrovimab) received market authorization in the United States of America in June 2025 for preventing RSV lower respiratory tract disease and is approved in over 40 countries as of September 23, 2026.

Available information on the maternal Pre-F vaccine and the mAb products nirsevimab and clesrovimab are summarized in this document, noting that the evidence on clesrovimab has not yet been formally reviewed by the WHO Strategic Advisory Group of Experts (SAGE) on immunization to inform recommendations for its use. On 3 September 2026, two additional long-acting mAbs (retavibart and clulevibart) for infant RSV prevention were approved in China. As their development and approval remain limited to China, they are noted but not reviewed in detail in this version.

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General indicators for RSV vaccines

Number of new cases per year (last 3-5 years)

Proportion of the population affected by the disease or infected with the antigen

Serogroup or serotype distribution (for serogroup- or serotype-specific vaccines)

Number of deaths from the disease per year

Case Fatality ratio (number of deaths / number of new cases, in %)

Outbreak, epidemic or pandemic risk

Contribution of the vaccine to achievement of the national, regional or global disease goals

Serogroup or serotype coverage by vaccines considered (for serogroup- or serotype-specific vaccines)

Efficacy and effectiveness estimates (e.g. against infection, disease, hospitalization, death), including in different populations

Duration of protection and waning of immunity in general and risk groups

Type, including severity, consequences and frequency of short- and long-term adverse events following vaccination

Perception of the target population on the risk of disease

Acceptability of the vaccine and of vaccination against the disease

Estimated financial cost of materials per vaccine dose (syringes, needles, safety box) (in USD)

Estimated vaccine financial cost per dose (in USD)

Estimated financial cost per person vaccinated (in USD)

Cost-effectiveness ratio

Is there a Gavi programme to support the introduction of this vaccine? If a Gavi programme is available, what support is available to countries?

Available vaccines, licensing status, prequalification status, presentation, formulation, dosage and route of administration

Number of doses and timing of administrations

Cold chain volume required per vaccine dose (in cm3)

Disclaimer

Data are mostly derived from recent WHO and NITAGs official publications, peer reviewed papers and other sources or other institutional publications; data are not the result of a systematic review and do not cover every aspect of the respective indicator. Users are encouraged to look at data sources in detail and any additional data that may be available (e.g., regional and national).