FLUENZ TETRA (four-component live attenuated nasal influenza vaccine) - Influenza vaccine

The Committee deems that the clinical benefit of FLUENZ TETRA (four-component live attenuated nasal influenza vaccine), remains substantial for seasonal influenza prevention in children with comorbidities from 2 to 17 years of age, according to the HCSP guidelines in force of 10 July 2014.

The Committee deems that the clinical benefit of FLUENZ TETRA (four-component live attenuated nasal influenza vaccine), is substantial for seasonal influenza prevention in children without comorbidities from 2 to 17 years of age, according to the HAS guidelines in force of 2 February 2023.

In view of:

• the non-inferior immunogenicity induced by FLUENZ TETRA (four-component live attenuated nasal influenza vaccine) to that of three-component live attenuated influenza vaccine (FLUENZ) against the three common strains in both vaccines, with a superior immune response against the additional B strain and a satisfactory safety profile (MI-CP208 study);
• the lack of specific clinical data with FLUENZ TETRA vaccine, the clinical efficacy of which is extrapolated from the three-component vaccine FLUENZ;
• the evidence of vaccination efficacy (VE) with live attenuated vaccines in lowering the incidence of laboratory-confirmed influenza cases (VE of 78%, CI95% = [59; 89]) and influenza syndromes (VE of 31%, CI95% = [20; 40]) based on the Cochrane review of 2018;
• the evidence of superiority of the three-component live attenuated nasal vaccine in relation to the three-component inactivated vaccine in terms of lowering the incidence of laboratory-confirmed influenza cases: RR of influenza (inactivate versus live attenuated) = 0.52, CI95% = [0.22; 0.82] (meta-analysis by Minozzi et al. 2022);
• the possible benefit of a four-component live attenuated nasal influenza vaccine in terms of the better acceptability of this vaccine among children given that needles are not used, which may have a potential positive impact on vaccination coverage;
• the lack of evidence of an impact in terms of lowering the incidence of acute otitis media, pneumonia, hospital admissions and mortality and without sufficient evidence making it possible to differentiate the four-component influenza vaccines available (inactivated vaccines or attenuated vaccines) on these clinical outcome measures of interest (Cochrane reviews 2018 and 2017, Minozzi 2022, Stuurman 2021 and Sinnathamby study 2022);
• the Committee deems that FLUENZ TETRA (four-component live attenuated nasal influenza vaccine) provides no clinical added value (CAV V) for seasonal influenza prevention in children without comorbidities from 2 to 17 years of age, according to the HAS guidelines in force of 2 February 2023.