Favourable opinion for reimbursement in active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in accordance with the current HAS recommendations of 27 June and 17 October 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 mRESVIA (Respiratory Syncytial Virus (RSV) mRNA vaccine (nucleoside modified)) 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 and 17 October 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 mRESVIA vaccinecompared to placebo in 35,088 subjects (P301 study) in terms of reduction in RSV-associated LRTD with ≥ 2 symptoms and RSV-associated LRTD with ≥ 3 symptoms (vaccine efficacy 83.7%, 95% CI 88% [66.0; 92.2]) and 82.4%, CI 96.36% [34.8; 95.3] respectively);
an acceptable safety profile of the mRESVIA vaccine, marked by predominantly grade 1 (mild) or 2 (moderate) adverse effects, such as injection site pain (56.3%), fatigue (31.0%) and headache (27.0%). Serious adverse events considered by the investigator to be causally related to the treatment were reported in the mRNA-1345 group in four subjects (chills, dehydration, facial nerve paralysis (occurring 5 days following injection of mRNA-1345) and superficial venous thrombosis) and in five subjects in the placebo group (seizures, fever, COPB, transient ischaemic attack and myelodysplastic syndrome).
But:
no evidence of an impact on reduction on severe RSV-associated LRTD and mortality due to RSV infections, as well as 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, mRESVIA (Respiratory Syncytial Virus (RSV) mRNA vaccine (nucleoside modified)) 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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