Nirsevimab Outperforms Maternal Vaccine in RSV Study
- Despite maternal RSVpreF vaccination being highly efficacious in trials, passive infant immunization with nirsevimab was associated with a consistently lower risk of RSV-related hospitalization and severe outcomes across...
- The population-based cohort study included real-world data from 42,560 infants (51.7% boys; mean age, 3.7 days; standard deviation [SD], 1.4 days) who were born in France between Sept.
- 481 infants (mean age, 38.9 days; SD, 22.2 days) were hospitalized for RSV-related lower respiratory tract infection (LRTI).
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- Researchers compared the outcomes of more than 40,000 infants who were immunized through nirsevimab or maternal RSV vac
Despite maternal RSVpreF vaccination being highly efficacious in trials, passive infant immunization with nirsevimab was associated with a consistently lower risk of RSV-related hospitalization and severe outcomes across most analyses, according to a recent study.
The population-based cohort study included real-world data from 42,560 infants (51.7% boys; mean age, 3.7 days; standard deviation [SD], 1.4 days) who were born in France between Sept. 1, 2024, and Dec.31, 2024. The researchers matched 21,280 infants who were exposed to the maternal RSV vaccine with 21,280 infants who received nirsevimab to compare each immunization’s effectiveness at preventing RSV-related complications. The median follow-up was 84 days (interquartile range, 70-99 days).
481 infants (mean age, 38.9 days; SD, 22.2 days) were hospitalized for RSV-related lower respiratory tract infection (LRTI). Of these, 212 (44.1%) had received nirsevimab and 269 (55.9%) were exposed to the maternal RSV vaccine.
Infants who received nirsevimab had a substantially lower risk for medically attended LRTI than those who were protected through maternal vaccination (adjusted HR = 0.74; 95% CI, 0.61-0.88). They were also less likely to be admitted to the pediatric ICU (aHR = 0.58; 95% CI, 0.42-0.8), need oxygen therapy (HR = 0.56; 95% CI, 0.38-0.81) or require a ventilator (HR = 0.57; 95% CI, 0.4-0.81). The researchers reported similar results in subgroup and sensitivity analyses.
Infants in the nirsevimab group experienced a decrease in risk for LRTI over time. During the first 7 days after enrollment, the risk for LRTI was nearly three times higher for infants in the nirsevimab group vs.the maternal vaccination group (aHR = 2.94; 95% CI, 1.19-7.69), however their risk was only half that of the maternal vaccination group after 60 days (aHR = 0.51; 95% CI, 0.3-0.86).
Both products are still relatively new – nirsevimab and the maternal vaccine were first implemented during the 2023-2024 respiratory season – and it will take several seasons’ worth of data to evaluate their performance in real-world settings.
“Our results should not be interpreted as evidence against maternal RSV vaccination,” Jabagi saeid. “Rather,they underscore that clinicians should individualize prevention strategies based on clinical context,access to care and timing within the RSV season. Both approaches remain valuable and might potentially be complementary, particularly in efforts to maximize population-level protection against RSV.”
For more facts:
Marie-Joelle Jabagi, PharmD, phd, MPH, can be reached at pediatrics@healio.com.
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