The FDA’s approval of a bivalent RSV prefusion F (RSVpreF) vaccine for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older was based on data from the phase 3 RENOIR trial. The double-blinded, randomized, placebo-controlled trial was conducted to study the efficacy and safety of the RSVpreF vaccine in older adults. Patients at least 60 years of age were eligible for the study, including those with chronic conditions such as chronic cardiopulmonary disease (eg, COPD and asthma), and were recruited from 240 sites. Patients who were immunocompromised were excluded from the study. The primary outcome measured was the efficacy of the RSVpreF vaccine in preventing RSV-associated lower respiratory tract illness with at least two signs or symptoms lasting more than one day and RSV infection that was confirmed using RT-PCR assay within 7 days after the onset of signs or symptoms. Outcomes in the primary analysis were assessed via conditional exact test based on the binomial distribution of the number of cases in the RSVpreF vaccine group.
Based on the primary analysis, RSV associated lower respiratory tract illness with at least two signs or symptoms occurred in 11 participants in the vaccine group (1.19 cases per 1,000 person years of observation) and 33 participants in the placebo group (3.58 cases per 1,000 person years of observation). Vaccine efficacy was 66.7%. RSV-associated acute respiratory illness occurred in 22 participants in the vaccine group (2.38 cases per 1,000 person years of observation) and 58 participants in the placebo group (6.30 cases per 1,000 person years of observation), with a vaccine efficacy of 62.1% (95% CI, 37.1-77.9).
Following the FDA approval, the CDC issued a recommendation supporting RSV vaccination for adults aged 60 and older. Further, the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) review conducted by the CDC for RSVpreF resulted in an evidence level of type 1 (high). The agency encourages shared decision making between patients and healthcare professionals to determine the benefits of RSV vaccine.
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