INFLUVAC TETRA (grippe pédiatrique + 6 mois) (antigènes de surface de virus de la grippe, inactivé)

Opinions on drugs - Posted on Feb 04 2022

Reason for request

New indication

Key points

Favourable opinion for reimbursement in the prevention of influenza in children from 6 months of age.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

In France, vaccination against seasonal influenza is recommended in all people aged 65 years and over and in the following special populations (see vaccine schedule):

  • pregnant women, regardless of the trimester of pregnancy;
  • people, from 6 months of age, with conditions promoting the onset of serious influenza complications;
  • obese people;
  • people staying in follow-on care facilities and medical-social care home residents;
  • families of infants under 6 months of age with serious influenza risk factors, as well as the families of immunocompromised individuals;
  • professionals in regular and prolonged contact with individuals with a severe influenza risk, in particular healthcare professionals and flight crews.

According to the vaccine recommendation adopted by the HAS board on 21 October 2021 relative to the INFLUVAC TETRA vaccine: “The HAS considers that the INFLUVAC TETRA vaccine may be used in accordance with its MA for infants and children aged from 6 to 35 months and in the context of the French seasonal influenza vaccination strategy aimed at preventing serious forms and deaths thanks to vaccination of specific populations”.

Role of the medicinal product in the care pathway

The Committee considers that INFLUVAC TETRA influenza vaccine (surface antigen, inactivated) may be used in accordance with its MA in children from 6 months of age for whom influenza vaccination is recommended, with the aim of preventing serious forms and deaths related to seasonal influenza (see current vaccine schedule).

 

 


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of INFLUVAC TETRA influenza vaccine (surface antigen, inactivated) is substantial in the prevention of influenza in infants and children from 6 months to 3 years of age for whom influenza vaccination is recommended.

 


Clinical Added Value

no clinical added value

Considering:

  • The immunogenicity induced by INFLUVAC TETRA influenza vaccine in children over 6 months of age,
  • A protective efficacy against influenza of 54% [95% CI: 0.37 to 0.66] (circulating seasonal influenza strain) and 68% [95% CI: 0.45 to 0.81] (antigenically coherent strains) in the study population of infants and young children, and a good safety profile,

but:

  • the absence of comparative clinical efficacy data for INFLUVAC TETRA compared to VAXIGRIPTETRA (quadrivalent influenza vaccine),

the Committee considers that INFLUVAC TETRA influenza vaccine provides no clinical added value (CAV V) compared to VAXIGRIPTETRA, indicated for the prevention of influenza in infants and children aged from 6 months to 3 years for whom vaccination is recommended.


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