FLUAD (trivalent influenza vaccine (surface antigen, inactivated, adjuvanted)) - Influenza vaccine

The clinical benefit of FLUAD (trivalent influenza vaccine (surface antigen, inactivated, adjuvanted)) is substantial in accordance with the current HAS vaccination recommendations dating from 6 February 2025.

Considering:

• data from the literature relating to clinical studies (in particular, randomised controlled trials versus standard-dose vaccines and meta-analyses) with adjuvanted trivalent influenza vaccines suggesting a superior efficacy to that of standard-dose vaccines, but with a low level of evidence due to heterogeneous results (varying depending on the influenza season considered, the influenza period studied within the same season, the viral strain, the match between the vaccine and the viral strains circulating, the study design considered, and the demographic and health characteristics of the study population),
• an at best modest size effect compared to standard-dose vaccines (around 25% concerning the reduction in non-laboratory-confirmed influenza cases and 15% concerning hospitalisations, and, to a lesser extent, emergency department admissions), and very low absolute effect differences,
• the lack of evidence of an additional impact on the reduction of deaths,
• the lack of adequate demonstration (in terms of effect size) of a difference with the EFLUELDA (trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain) high-dose vaccine,
• the supposed benefit of an adjuvanted trivalent influenza vaccine due to the immunosenescence that can affect the vaccine response in individuals 65 years of age and older,

the Committee considers that FLUAD (trivalent influenza vaccine (surface antigen, inactivated, adjuvanted)) provides a minor clinical added value (CAV IV) compared to the other vaccines recommended in the prophylaxis of seasonal influenza in adults 65 years of age and older, in accordance with the current HAS recommendations.