Favourable opinion for reimbursement in active immunisation for the prevention of lower respiratory tract disease caused by RSV in accordance with the current HAS recommendations of 27 June 2024, i.e. in individuals 75 years of age and older, and individuals 65 years of age and older with a chronic respiratory disease (in particular COPD) or heart condition (in particular heart failure) liable to decompensate in the event of RSV infection.
Clinical Benefit
Moderate
The Committee deems that the clinical benefit of AREXVY (Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)) is moderate in active immunisation for the prevention of lower respiratory tract disease caused by RSV in accordance with the current HAS recommendations of 27 June 2024, i.e. in individuals 75 years of age and older, and individuals 65 years of age and older with a chronic respiratory disease (in particular COPD) or heart condition (in particular heart failure) liable to decompensate in the event of RSV infection.
Clinical Added Value
no clinical added value
Considering:
the inadequately met medical need in the prevention of lower respiratory tract disease caused by RSV in individuals 75 years of age and older, and individuals 65 years of age and older with a chronic respiratory disease (in particular COPD) or heart condition (in particular heart failure),
demonstration of a superiority of the AREXVY vaccine compared to placebo in 24,966 subjects (study (RSV OA=ADJ-006) in terms of reduction in RSV-associated LRTD confirmed by RT-PCR (vaccine efficacy of 82.6%, CI95%= [57.9; 94.1], p< 0.0001, 15 days after administration of a single dose of vaccine, primary endpoint) and in terms of reduction in severe RSV-associated LRTD (vaccine efficacy of 94.1%, CI95% = [62.4; 99.9], secondary endpoint),
an acceptable safety profile of the AREXVY vaccine, marked by predominantly grade 1 (mild) or 2 (moderate) adverse effects, such as pain (60.9%), fatigue (33.6%) and myalgia (28.9%). One case of Guillain-Barré syndrome having occurred 9 days following administration of AREXVY was assessed by the investigator as being potentially related to the vaccine administered.
But:
no evidence of an impact on reduction on mortality due to RSV infections, or on the organisation of care (reduction in conventional hospitalisations and intensive care unit admissions),
limited data in the populations at highest risk of decompensating following RSV infection (individuals 75 years of age and older, and individuals 65 years of age and older with a chronic respiratory disease (in particular COPD) or heart condition (in particular heart failure)), limiting the transposability of the results in this population,
the Committee deems that, on the basis of currently available data, AREXVY (Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)) provides no clinical added value (CAV V) in active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in individuals 75 years of age and older, and individuals 65 years of age and older with a chronic respiratory disease (in particular COPD) or heart condition (in particular heart failure) liable to decompensate in the event of RSV infection.
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