Importance: Two interventions to prevent severe respiratory syncytial virus (RSV) in infants were approved in 2023-a bivalent prenatal RSV prefusion F protein-based (RSVpreF) vaccine and an infant monoclonal antibody (nirsevimab). Understanding their uptake and clinical outcomes is essential for public health planning.
Objective: To describe uptake of the prenatal RSVpreF vaccine and infant nirsevimab.
Design, Setting, And Participants: This retrospective cohort study was conducted at a single academic center among 647 pregnant individuals eligible for RSVpreF vaccination (32-36 weeks' gestation between October 15, 2023, and January 31, 2024) and infants eligible for nirsevimab (no prenatal RSVpreF vaccination >14 days before delivery).
Exposure: Pregnancy or birth during the 2023-2024 RSV season.
Main Outcomes And Measures: RSVpreF vaccination among eligible pregnant individuals and nirsevimab administration prior to hospital discharge among eligible infants.
Results: Of 647 eligible pregnant individuals (mean [SD] age, 34.6 [6.2] years; 355 nulliparous [54.9%]; 558 privately insured [86.2%]), 414 (64.0%) received the RSVpreF vaccine. Factors associated with higher RSVpreF uptake included older birthing parent age (adjusted odds ratio [AOR], 1.09; 95% CI, 1.05-1.12), nulliparity (AOR, 1.84; 95% CI, 1.31-2.60), private insurance (AOR, 2.19; 95% CI, 1.27-3.80), non-Hispanic ethnicity (AOR, 2.36; 95% CI 1.57-3.55; reference: Hispanic), receipt of any COVID-19 vaccine (AOR, 7.12; 95% CI, 3.91-13.70), 2023-2024 formula COVID-19 booster vaccine (AOR, 5.62; 95% CI, 3.80-8.48), influenza vaccine (AOR, 8.14; 95% CI, 5.38-12.50), or tetanus-diphtheria-pertussis vaccine (AOR, 6.86; 95% CI, 3.79-13.10). Factors associated with lower RSVpreF uptake included non-English language preference (AOR, 0.24; 95% CI, 0.10-0.52), Black race (AOR, 0.30; 95% CI, 0.16-0.57; reference: Asian), other or unknown race (AOR, 0.48; 95% CI, 0.30-0.76), and multiple gestation (AOR, 0.27; 95% CI, 0.07-0.88). Nirsevimab was administered to 183 of 261 eligible infants (70.1%) prior to hospital discharge. Among those who did not receive RSVpreF or standard prenatal vaccines, 40.4% of their neonates (19 of 47) received nirsevimab; among those who declined infant hepatitis B vaccination, 34.0% of their neonates (17 of 50) received nirsevimab. Respiratory syncytial virus coverage exceeded 80% during all months of the study period except October 2023, the first month during which prenatal RSV vaccination and infant nirsevimab were available. Preterm delivery occurred in 35 of 414 RSVpreF-vaccinated individuals (8.5%) and 43 of 233 unvaccinated individuals (18.5%). In a nested case-control analysis with preterm birth as the outcome, there was no significant association between RSVpreF vaccination and preterm birth (AOR, 1.03; 95% CI, 0.55-1.93).
Conclusions And Relevance: In this cohort study, uptake of the RSVpreF vaccine and infant nirsevimab was high. Nirsevimab uptake was high even among individuals who did not receive routine prenatal or infant vaccines. There was no significant association between RSVpreF vaccination and preterm birth. This study suggests that an RSV prevention strategy that included both prenatal vaccination and infant monoclonal antibody administration had high uptake and reassuring perinatal outcomes.
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http://dx.doi.org/10.1001/jamanetworkopen.2024.60735 | DOI Listing |
Vaccines (Basel)
February 2025
Vaccine Research and Development, Pfizer Ltd., Marlow SL7 1YL, UK.
Concomitant administration may improve vaccination rates. This analysis of a phase 1/2 randomized study included 1073 healthy ≥65-year-olds who previously received ≥3 mRNA COVID-19 vaccine doses. Participants received concomitantly administered RSVpreF and bivalent BA.
View Article and Find Full Text PDFBMC Med
February 2025
School of Pharmacy, Memorial University of Newfoundland, 300 Prince Philip Drive, St. John's, NL, A1B 3V6, Canada.
Background: Nirsevimab, a long-acting monoclonal antibody, and RSVpreF, a maternal vaccine, are newly approved respiratory syncytial virus (RSV) prophylactics for infants in Canada. Both have the potential to expand prevention efforts, but there is limited evidence regarding their cost-effectiveness and how it varies across the country, despite disparate hospitalisation rates and resource use among different populations.
Methods: We developed a decision tree model to follow twelve monthly birth cohorts through their first year of life, incorporating risk differentiation based on Canadian region, prematurity, and comorbidities.
JAMA Netw Open
February 2025
Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
JAMA Netw Open
February 2025
Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.
Importance: Two interventions to prevent severe respiratory syncytial virus (RSV) in infants were approved in 2023-a bivalent prenatal RSV prefusion F protein-based (RSVpreF) vaccine and an infant monoclonal antibody (nirsevimab). Understanding their uptake and clinical outcomes is essential for public health planning.
Objective: To describe uptake of the prenatal RSVpreF vaccine and infant nirsevimab.
Clin Infect Dis
February 2025
Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Background: RSV is an important cause of lower respiratory tract illness (LRTI) in older adults. RSVpreF is a bivalent stabilized prefusion F vaccine containing antigens against RSV-A and RSV-B. In this phase 3 trial in ≥60-year-olds, RSVpreF demonstrated vaccine efficacy (VE) of 88.
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