Bibliographic information

GuidelineWHO position paper on immunization to protect infants against respiratory syncytial virus disease, May 2025
Year of Publication2025
Issuing InstitutionWorld Health Organization

Recommendation

New

[Immunization to protect infants against respiratory syncytial virus disease]. For countries deciding to use the maternal vaccine as the primary preventive strategy, WHO recommends administering a single dose of RSVpreF in the third trimester of pregnancy, as defined in the local context (defined as ≥28 weeks gestation in most settings)

Recommended

Notes and Remarks

The recommendation for use is not conditional to every country conducting disease or safety surveillance for pregnancy outcomes. However, SAGE recommends monitoring for safety in pregnancy in multiple settings across country income groups. This should include using standardized case definitions for important birth outcomes, such as preterm birth and low birthweight (i.e., Brighton Collaboration Global Alignment of Immunization Safety in Pregnancy (GAIA) project). Even when administered in the weeks immediately before delivery, the transfer of lesser amounts of antibodies is still likely to provide some protection. Therefore, no upper limit of week of gestation for vaccination is recommended except for women in active labour who should not receive the RSV vaccine. Although a causal link between maternal RSV vaccination and preterm birth has not been established, the recommendation to limit vaccination to the third trimester is precautionary. This precludes any possibility of the vaccine being associated with extremely preterm births before the third trimester because these have the highest risk of mortality and serious sequelae. Moreover, a third trimester recommendation still provides opportunities for achieving high vaccine coverage through ANC contacts, while allowing adequate time for transplacental antibody transfer to confer protection, including for most premature infants who are at higher risk of severe RSV. A third trimester vaccine recommendation also can enhance programmatic feasibility in LMICs by linking the vaccine with the increased number of ANC contacts and other ANC recommendations during the third trimester.