RSV vaccines | NITAG RESOURCE CENTER

Benefits of the intervention

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

Current RSV immunization products protect against both subgroups of RSV. ^{Go to footnote 11, Go to footnote 22}

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

For maternal RSVPreF: Vaccine efficacy against RSV-positive severe medically-attended LRTI at 180 days after birth was 70 % (50.6, 82.5) and 49.2% (31.4, 62.8) against RSV-positive medically attended LRTI. ^{Go to footnote 33}

For nirsevimab: Efficacy against medically attended RSV-associated LRTI was 79% (68.5, 86.1). Efficacy against hospitalization for RSV-associated LRTI was 80.6% (62.3, 90.1) and efficacy against severe hospitalized RSV-associated LRTI was 78.5% (48.8,91.0). ^{Go to footnote 44, Go to footnote 55}

Both products have been shown to have high, similar effectiveness when used in real-world situations.

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

The duration of protection is between 5-6 months. RSV antibody titers remained high 6 months after birth in infants born to mothers vaccinated with the maternal RSVPreF vaccine. Similarly, efficacy outcomes measured at 5 months after nirsevimab administration indicated protection at 5 months. ^{Go to footnote 66, Go to footnote 77, Go to footnote 88}

Sources

Go back to footnote reference 1
European Medicines Agency (n.d.). Abrysvo: EU summary of product characteristics [product information document]. Amsterdam: EMA (https://www.ema.europa.eu/en/documents/product-information/abrysvo-epar-product-information_en.pdf, accessed 19 June 2025).
Go back to footnote reference 2
European Medicines Agency (n.d.). Beyfortus: EU summary of product characteristics [product information document]. Amsterdam: EMA (https://www.ema.europa.eu/en/documents/product-information/beyfortus-epar-product-information_en.pdf, accessed 19 June 2025).
Go back to footnote reference 3
Müller WJ, Madhi SA, Seoane Nuñez B, Baca Cots M, Bosheva M, Dagan R, et al. (2023). Nirsevimab for prevention of RSV in term and late-preterm infants. N Engl J Med. 388:1533–1534. doi:10.1056/NEJMc2214773.
Go back to footnote reference 4
Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, et al. (2020). Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med. 383:415–425. doi:10.1056/NEJMoa1913556.
Go back to footnote reference 5
Kampmann B, Madhi SA, Munjal I, Simões EAF, Pahud BA, Llapur C, et al. (2023). Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 388:1451–1464. doi:10.1056/NEJMoa2216480.
Go back to footnote reference 6
United States Food and Drug Administration (2023). Vaccines and Related Biological Products Advisory Committee meeting, 18 May 2023: FDA briefing document. Silver Spring (MD): US FDA (https://www.fda.gov/media/168185/download, accessed 20 June 2025).
Go back to footnote reference 7
Kampmann B, Madhi SA, Munjal I, Simões EAF, Pahud BA, Llapur C, et al. (2023). Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 388:1451–64.
Go back to footnote reference 8
Simões EAF, Madhi SA, Muller WJ, Atanasova V, Bosheva M, Cabañas F, et al. (2023). Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomized controlled trials. Lancet Child Adolesc Health. 7(3):180–89. doi:10.1016/S2352-4642(22)00321-2.