Search Results (4)

Background: Respiratory syncytial virus (RSV) is a common cause of acute respiratory infection (ARI). The risk of severe RSV outcomes is higher among older adults (OAs) and individuals with chronic diseases (high risk, HR). AS01_E-adjuvanted RSV preFusion protein 3 OA vaccine (adjuvanted RSVPreF3 OA is approved for the prevention of lower respiratory tract disease [LRTD] due to RSV in OAs). The objective of this study was to assess the potential public health impact of an RSV vaccination program using adjuvanted RSVPreF3 OA in adults ≥75 years (y) and HR adults ≥60 y in Italy. Methods: A static multi-cohort Markov model was used to estimate the number of RSV cases and associated health outcomes projected in adults ≥75 y and HR adults ≥60 y with no RSV vaccination or with a single dose of adjuvanted RSVPreF3 OA. Epidemiological, healthcare resource use and cost data were obtained from the scientific literature. Vaccine efficacy and waning inputs were based on results from the AReSVi-006 phase III clinical trial. Several scenarios for vaccine coverage were explored. Results: Assuming the target vaccination rate for influenza vaccination in Italy (75%), the model predicted that vaccinating Italian adults ≥75 y and the HR population ≥ 60 y with adjuvanted RSVPreF3 OA would reduce the number of RSV-LRTD events by 43%, leading to a reduction in associated emergency department visits, hospitalizations, complications, deaths, and direct healthcare costs over a 3-year period. Conclusions: The vaccination of Italians aged ≥ 75 y and HR individuals aged ≥ 60 y using the adjuvanted RSVPreF3 OA vaccine has the potential to offer substantial public health benefits by reducing the burden of RSV disease. Full article

Respiratory syncytial virus (RSV) causes significant morbidity and mortality, especially in young children and the elderly. RSV vaccine development puzzled vaccinologists for years. Safety concerns of initial formulations, the lack of an absolute correlate of protection, and the need for selecting appropriate virus attenuation and antigen–adjuvant combinations contributed to delayed vaccine production. The recent stabilization of the RSV-F glycoprotein in the prefusion (preF) conformation that constitutes the primary target of RSV-neutralizing antibodies was key for efficient vaccine design. Two protein subunit vaccines (GSK’s Arexvy and Pfizer’s Abrysvo) and one mRNA RSV vaccine (Moderna’s mRESVIA) are now available. This article aims to provide a comparative overview of the safety and efficacy of novel RSV vaccines that are approved for the prevention of RSV-lower respiratory tract disease (LRTD) in adults 60 years of age and older, with updated recommendations calling for the expansion of vaccination to all adults at increased risk for severe RSV disease. Abrysvo is the only vaccine indicated for use in pregnancy to prevent RSV-LRTD in infants from birth to 6 months of age. We provide a comparative assessment of the efficacy of approved RSV vaccines over a maximum of three seasons, summarizing currently available data. We conclude that despite the decreasing vaccine efficacy over time, which should be anticipated for a virus that is characterized by short-term immunity, efficacy was clinically meaningful over placebo. The increased risk of Guillain–Barré syndrome post vaccination with Abrysvo or Arexvy, which prompted the FDA to require the inclusion of such warnings in the prescribing information of these two RSV vaccines, should be prioritized and investigated thoroughly. Furthermore, ongoing vaccine surveillance and further evaluation, particularly among immunocompromised patients, frail elderly subjects, and young infants that were under- or not represented in pivotal clinical trials, are necessary. As in the success story of combined pediatric vaccines, combination vaccines, conferring protection against several respiratory illnesses in one dose, could help improve vaccine acceptance and coverage rates in older adults. Full article

A systematic review with a meta-analysis was performed to gather available evidence on the effectiveness of monoclonal antibody nirsevimab in the prevention of lower respiratory tract diseases (LRTDs) due to respiratory syncytial virus (RSV) in children and newborns (CRD42024540669). Studies reporting on real-world experience and randomized controlled trials (RCTs) were searched for in three databases (PubMed, Embase, and Scopus) until 1 May 2024. Our analysis included five RCTs, seven real-world reports, and one official report from the health authorities. Due to the cross-reporting of RCTs and the inclusion of multiple series in a single study, the meta-analysis was performed on 45,238 infants from 19 series. The meta-analysis documented a pooled immunization efficacy of 88.40% (95% confidence interval (95% CI) from 84.70 to 91.21) on the occurrence of hospital admission due to RSV, with moderate heterogeneity (I² 24.3%, 95% CI 0.0 to 56.6). Immunization efficacy decreased with the overall length of the observation time (Spearman’s r = −0.546, p = 0.016), and the risk of breakthrough infections was substantially greater in studies with observation times ≥150 days compared to studies lasting <150 days (risk ratio 2.170, 95% CI 1.860 to 2.532). However, the effect of observation time in meta-regression analysis was conflicting (β = 0.001, 95% CI −0.001 to 0.002; p = 0.092). In conclusion, the delivery of nirsevimab was quite effective in preventing hospital admissions due to LRTDs. However, further analyses of the whole RSV season are required before tailoring specific public health interventions. Full article

A systematic review and meta-analysis was designed in order to ascertain the effectiveness of respiratory syncytial virus (RSV) vaccination in preventing lower respiratory tract diseases (LRTD) in older adults (age ≥ 60 years). Studies reporting on randomized controlled trials (RCTs) were searched for in three databases (PubMed, Embase, and Scopus) and the preprint repository medRxiv until 31 March 2024. A total of nine studies were eventually included, two of which were conference proceedings. Our analysis included five RCTs on five RSV vaccines (RSVpreF, RSVPreF3, Ad26.RSV.preF, MEDI7510, and mRNA-1345). The meta-analysis documented a pooled vaccine efficacy of 81.38% (95% confidence interval (95% CI) 70.94 to 88.06) for prevention of LRTD with three or more signs/symptoms during the first RSV season after the delivery of the vaccine. Follow-up data were available for RSVPreF3 (2 RSV seasons), RSVpreF (mid-term estimates of second RSV season), and mRNA-1345 (12 months after the delivery of the primer), with a pooled VE of 61.15% (95% CI 45.29 to 72.40). After the first season, the overall risk for developing RSV-related LRTD was therefore substantially increased (risk ratio (RR) 4.326, 95% CI 2.415; 7.748). However, all estimates were affected by substantial heterogeneity, as suggested by the 95% CI of I2 statistics, which could be explained by inconsistencies in the design of the parent studies, particularly when dealing with case definition. In conclusion, adult RSV vaccination was quite effective in preventing LRTD in older adults, but the overall efficacy rapidly decreased in the second season after the delivery of the vaccine. Because of the heterogenous design of the parent studies, further analyses are required before tailoring specific public health interventions. Full article