ABRYSVO (respiratory syncytial virus vaccine (bivalent, recombinant)) - Respiratory syncytial virus (RSV)

The Committee deems that the clinical benefit of ABRYSVO (respiratory syncytial virus vaccine (bivalent, recombinant)) is moderate in the passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy at 32 to 36 weeks of gestation only, in accordance with the current HAS recommendations of 6 June 2024.

Considering:

• the inadequately met medical need in the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season;
• demonstration of the superiority of the ABRYSVO vaccine versus placebo in 6,975 infants born to individuals vaccinated during pregnancy in terms of reduction in severe RSV LRTI cases up to D180 (0.5% in the ABRYSVO group versus 1.8% in the placebo group), i.e. a vaccine efficacy of 69.4% [44.3; 84.1];
• an acceptable safety profile of the ABRYSVO vaccine, marked by predominantly grade 1 (mild) or 2 (moderate) adverse effects, such as pain at the vaccination site (41%), headaches (31%) and myalgia (27%). However, pharmacovigilance follow-up is necessary due to a potential excess risk of premature births (not significant for this vaccine, but having led to the development of a concurrent vaccine being stopped);

But:

• a non-significant reduction in the incidence of RSV LRTI cases (co-primary endpoint): 0.7% in the ABRYSVO group versus 1.6% in the placebo group, i.e. a vaccine efficacy (VE) of 57.1% [14.7; 79.8]; deemed to be non-significant because the lower limit of the CI is below 20% in the 90 days following birth:
  • a reduction in hospitalisations (secondary endpoint): VE of 67.7%, CI17% = [15.9; 89.5] reported at D90 after birth before decreasing over time, to values of 59.5% [8.3; 83.7], 56.4% [5.2; 81.5], 56.8% [10.1; 80.7], 33.3% [-17.6; 62.9] at D120, 150, 180 and 360 after birth, respectively;
  • no evidence of an impact on reduction in the length of hospital stay, transfer to critical or intensive care units and mortality due to RSV infections;
  • the lack of comparative data enabling robust differentiation between maternal vaccination during pregnancy compared to the alternative strategy of passive immunisation from birth using monoclonal antibodies;

The Committee deems that ABRYSVO (respiratory syncytial virus vaccine (bivalent, recombinant)) provides a clinical added value (CAV IV) in the passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy at 32 to 36 weeks of gestation only.