★ New data confirm the cost-effectiveness of the RSV immunization strategy.

GSK launched the study “Efficacy of adjuvanted vaccine against respiratory syncytial virus (RSV) in adults in Spain”¹ which aims to evaluate the effectiveness of vaccination of adults aged ≥60 years with an adjuvanted RSV vaccine by adapting a Markov model that estimates the incremental cost-effectiveness ratio (ICER) of an immunization strategy versus vaccination without an adjuvant. The analysis was carried out from the perspective of the National Health System (NHS), so only direct health care costs were considered. The study was presented at the congress of the Spanish Association of Vaccinologists (AEV), which took place in Malaga from 24 to 26 October.

The study can consider a five-year time horizon due to new data on the efficacy of a single dose of adjuvanted RSV vaccine in older adults demonstrating sustained efficacy over at least three full RSV seasons (assuming proportional losses in efficacy from this period in the model). moment), presented at the CHEST Congress, held October 6-9 last year.

Base case results showed an ICER for vaccination of adults aged ≥60 years (12,845,910 inhabitants) with RSVPreF3 OA vaccine of €17,062 per QALY gained.¹. Likewise, this ratio was seen to improve even further in populations at higher risk, such as older people (ICER 15,502, 15,911 and 15,424 €/QALY for ≥65, ≥70 and ≥75 years, respectively) or people with concomitant diseases. (populations with COPD, asthma, diabetes or cardiovascular disease) who would benefit most from vaccination, showing an ICER of €8,139/QALY. This ratio also improved when the indirect impact of RSV infections was considered from a societal perspective (ICER: €15,855/QALY).¹. In addition, the main results were supported by a probabilistic sensitivity analysis showing that 99% of simulations would be below the willingness-to-pay threshold of €25,000/QALY.¹. Therefore, given this theoretical threshold, vaccination of individuals aged ≥60 years with an adjuvanted RSV vaccine would be an effective strategy for SNS in the prevention of lower respiratory tract diseases (LRTD) caused by RSV in Spain.¹.

Pulmonologist Felipe Villar, deputy director of the pulmonology service at the Jiménez Díaz University Hospital and one of the authors of the analysis, comments: “The results obtained in this study show the effectiveness of the adjuvanted RSV vaccine, especially in those populations that may benefit most from vaccination because they are at higher risk of developing severe disease, such as adults over 70 years of age and populations with COPD, asthma, diabetes or cardiovascular disease diseases. These results may help guide decisions regarding the development of future changes to the national adult immunization schedule, ensuring effective implementation into the national health system schedule, especially for adults and patients with chronic respiratory diseases, who are particularly vulnerable to infections. this virus and where this vaccination should be a priority.”

First RSV vaccine with three seasons of data

GSK announced at this year’s CHEST conference organized by American College of Chest Physiciansnew data from the phase III AReSVi-006 trial evaluating the effectiveness of a single dose of GSK’s RSV vaccine in adults over 60 years of age in reducing the risk of developing respiratory tract-related lower respiratory tract disease (LRTI) and severe forms. ETRI for three RSV seasons². These results make the GSK RSV vaccine the only one that currently has three seasons of surveillance data.³.

The study shows that after a single dose of the GSK RSV vaccine, the cumulative effectiveness against RSV over three seasons was clinically significant at 69.1% against RSV ETRI (97.5% CI, 55.8-78.9 48 of 12,468 against 215 out of 12,498). ), 72.3% compared with severe RSV RTRI (95% CI, 51.3–85.2; 75 of 12,498) and 71.1% compared with RSV ETRI in patients with at least one comorbidity of interest† (95% CI, 55.2–82.0 25 of 5014 vs. 116 of 4951) compared with placebo and without seasonality as a covariate in the statistical analysis;³.*

These results include effectiveness against various RSV subtypes in older adults (70–79 years), in those with certain underlying medical conditions, and in cases where medical attention is required.³. Because RSV can aggravate underlying disease and potentially lead to hospitalization, the cumulative effectiveness of RSV over three seasons could have a significant health impact and offer healthcare providers flexibility in administering the vaccine year-round. The clinical development program will continue to evaluate long-term follow-up to provide information on the optimal timing of possible revaccination.

About AReSVi-006

This is a multinational, randomized, placebo-controlled, blinded, Phase III clinical trial designed to demonstrate the efficacy of a single dose of GSK adjuvanted RSV vaccine in adults aged 60 years and older for 3 years with an annual booster schedule. Some 25,000 participants were attracted from 17 countries, including Spain. The primary objective of the study was to test efficacy against RSV-LRTD after a season of RSV infection. The first results were published in a scientific journal New England Journal of Medicine in February 2023⁴.

After the first season, 12,469 participants in the vaccination group were randomized to receive either RSV vaccine or placebo and were monitored for RSV-LRTD. Secondary endpoints were single-dose RSV-LRTD vaccine efficacy after two and three seasons, and vaccine efficacy after annual booster vaccination.

*Efficacy data shown does not include seasonality as a statistical covariate. Per-protocol statistical analyzes included age, region, and seasonality variables to adjust data. Seasonality allows us to account for potential changes between study seasons, such as RSV incidence, sample size, follow-up time, or efficacy. In summary, the efficacy data adjusted for seasonality included in the statistical analysis are as follows: efficacy against RSV ETRI, 62.9% (97.5% CI 46.7–74.8); efficacy against severe RSV ETRI 67.4% (95% CI 42.4-82.7); ETRI due to RSV in participants with at least one comorbidity of interest was 64.7% (95% CI 45.1–78.1).

† Comorbidities of interest: COPD, asthma, any chronic airway or lung disease, type 1 or 2 diabetes, congestive heart failure, advanced liver or kidney disease.

About RSV in older people

RSV is a common contagious virus that affects the lungs and airways. Older adults are at high risk of developing severe RSV due to age-related immune decline and underlying medical conditions they may have. RSV can worsen conditions such as chronic obstructive pulmonary disease (COPD), asthma and congestive heart failure, and lead to serious complications including pneumonia, hospitalization and death.⁵. Adults with underlying medical conditions are more likely to require medical consultation and have higher hospitalization rates than adults without these medical conditions.

Links:

1. Gil de Miguel A, Villar F, Menendez R, et al. Efficacy of the adjuvanted respiratory syncytial virus (RSV) vaccine, RSVPreF3 OA, for immunization of adults in Spain. Presented at the XII Congress of the Spanish Association of Vaccinologists, 24-26 October 2024, Malaga, Spain. Available in the Congress app.
2. Clinicaltrials.gov, “Efficacy Study of GSK’s Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults 60 Years of Age and Over.” Available online at: https://clinicaltrials.gov/study/NCT04886596. Last accessed: September 2024
3. Ison M.G. et al. Abstracts presented at the CHEST 2024 conference, October 6–9, 2024, Boston, USA.
4. Papi A. et al., “F protein vaccine for respiratory syncytial virus prefusion in the elderly,” in New England Journal of Medicine, 2023; 388:595-608 DOI: 10.1056/NEJMoa2209604
5. Centers for Disease Control and Prevention (CDC), RSV in Older Adults and Adults with Chronic Diseases, 2023.