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 ABRYSVO (Respiratory Syncytial Virus (RSV) vaccine (bivalent, recombinant)) 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 ABRYSVO vaccinecompared to placebo in 34,383 subjects (RENOIR study) in terms of reduction in RSV-associated LRTD with ≥ 2 symptoms and RSV-associated LRTD with ≥ 3 symptoms, (vaccine efficacy 67% CI66% [29;86]) and 86% CI96.66% [32;99] respectively),
an acceptable safety profile of the ABRYSVO vaccine, marked by predominantly grade 1 (mild) or 2 (moderate) adverse effects, such as fatigue (15.5%) and pain at the vaccination site (10.5%). One case of Guillain-Barré syndrome and one case of Miller-Fisher syndrome having occurred 7 and 8 days following administration of ABRYSVO were assessed by the investigator as being potentially related to the vaccine administered (RENOIR study).
But:
no evidence of an impact on reduction on severe RSV-associated LRTD and 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, ABRYSVO (Respiratory Syncytial Virus (RSV) vaccine (bivalent, recombinant)) provides no clinical added value (CAV V) in active immunisation for 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) liable to decompensate in the event of RSV infection.
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