EVIDENCE-BASED BENEFIT-RISK ASSESSMENT OF THE RSVPREF VACCINE IN ADULTS AGED =60 YEARS
Author(s)
Richard CHIV, MSc.1, Aurore Bergamasco, PharmD, MSc.2, Jenny Sun, Phd3, Yola Moride, PhD1;
1YolaRx Consultants, Montreal, QC, Canada, 2YolaRx Consultants, Paris, France, 3Pfizer Inc., New York, NY, USA
1YolaRx Consultants, Montreal, QC, Canada, 2YolaRx Consultants, Paris, France, 3Pfizer Inc., New York, NY, USA
Presentation Documents
OBJECTIVES: A benefit-risk assessment (BRA) of the RSVpreF vaccine, indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD), was conducted to evaluate whether the benefits of vaccination outweigh the risks - particularly Guillain-Barré syndrome (GBS) - among adults aged ≥60 years.
METHODS: A systematic literature review (SLR) covering January 1, 2018, to September 2, 2025, was conducted to identify data from clinical trials and real-world studies comparing RSVPreF with no RSV vaccination. Evidence was evaluated for Season 1 (range: 2021-2025), Season 2 (2022-2023), and across both seasons. Using a qualitative BRA framework, benefits were estimated as the number of RSV-LRTD cases with ≥3 symptoms (severe disease), hospitalizations, and deaths prevented. Risks were estimated as the number of GBS events occurring within 42 days of RSV vaccination, along with any other serious adverse events. A quantitative analysis using stochastic multicriteria acceptability analysis (SMAA) was conducted to assess the overall benefit-risk rankings.
RESULTS: Of 31 publications identified in the SLR, 10 provided data suitable for the BRA; 21 were not considered due to the absence of absolute risk estimates or patient counts. Per 1,000,000 vaccinated individuals, RSVpreF was estimated to prevent 885 (95% confidence interval [CI]: 451-1,475) RSV-LRTD cases with ≥3 symptoms, 1,097 (95% CI: 914-1,281) RSV-related hospitalizations, 948 (95% CI: 781-1,114) RSV-emergency department visits, and 90 (95% CI: 37-142) RSV-related deaths. In contrast, the excess risk of GBS was estimated at 9 cases per 1,000,000 vaccinated individuals (95% CI: -0.02-18). In the quantitative analysis, RSVpreF ranked first compared to no RSV vaccination in 81.79% of 100,000 simulations. Supplementary and sensitivity analyses, including best-case and worst-case scenarios, yielded consistent findings.
CONCLUSIONS: Based on the available evidence, this analysis indicates a positive benefit-risk balance for the RSVpreF vaccine compared with no RSV vaccination in adults aged ≥60 years.
METHODS: A systematic literature review (SLR) covering January 1, 2018, to September 2, 2025, was conducted to identify data from clinical trials and real-world studies comparing RSVPreF with no RSV vaccination. Evidence was evaluated for Season 1 (range: 2021-2025), Season 2 (2022-2023), and across both seasons. Using a qualitative BRA framework, benefits were estimated as the number of RSV-LRTD cases with ≥3 symptoms (severe disease), hospitalizations, and deaths prevented. Risks were estimated as the number of GBS events occurring within 42 days of RSV vaccination, along with any other serious adverse events. A quantitative analysis using stochastic multicriteria acceptability analysis (SMAA) was conducted to assess the overall benefit-risk rankings.
RESULTS: Of 31 publications identified in the SLR, 10 provided data suitable for the BRA; 21 were not considered due to the absence of absolute risk estimates or patient counts. Per 1,000,000 vaccinated individuals, RSVpreF was estimated to prevent 885 (95% confidence interval [CI]: 451-1,475) RSV-LRTD cases with ≥3 symptoms, 1,097 (95% CI: 914-1,281) RSV-related hospitalizations, 948 (95% CI: 781-1,114) RSV-emergency department visits, and 90 (95% CI: 37-142) RSV-related deaths. In contrast, the excess risk of GBS was estimated at 9 cases per 1,000,000 vaccinated individuals (95% CI: -0.02-18). In the quantitative analysis, RSVpreF ranked first compared to no RSV vaccination in 81.79% of 100,000 simulations. Supplementary and sensitivity analyses, including best-case and worst-case scenarios, yielded consistent findings.
CONCLUSIONS: Based on the available evidence, this analysis indicates a positive benefit-risk balance for the RSVpreF vaccine compared with no RSV vaccination in adults aged ≥60 years.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EPH83
Topic
Epidemiology & Public Health
Topic Subcategory
Public Health
Disease
SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory), STA: Vaccines