FLUAD TETRA (antigènes de surface du virus de la grippe, inactivé) (prévention de la grippe (65 ans et +)

Opinions on drugs - Posted on Sep 02 2022

Reason for request

First assessment

Key points

Favourable opinion for reimbursement in prophylaxis of influenza in people aged 65 years and over.

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;
people in the environment of infants under 6 months of age with serious influenza risk factors, as well as the people in the environment 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 18 November 2021 relative to FLUAD TETRA vaccine: “At the end of its assessment, the HAS considers that FLUAD TETRA can be used, in the same way as the other influenza vaccines marketed in France, within the framework of the French vaccination strategy against seasonal influenza, the aim of which is to reduce severe forms and deaths attributable to influenza. In accordance with its marketing authorisation, FLUAD TETRA must be used in patients 65 years of age and older.”

Role of the medicinal product in the care pathway

The Committee considers that FLUAD TETRA influenza vaccine (surface antigen, inactivated, adjuvanted) is a new method for the prevention of seasonal influenza in people aged 65 years and over, in the same way as the other standard-dose or high-dose quadrivalent vaccines available.

The Committee reiterates the fact that vaccination is the most effective tool to prevent influenza and its associated complications, particularly in at-risk populations. Good vaccination coverage, including in caregivers, is essential.

In addition, protective hygiene measures (wearing surgical masks and frequent hand washing) help limit the risk of transmission and contamination, particularly in very young children and people with specific risk factors. These two measures form the cornerstone of influenza prevention.

Clinical Benefit

Substantial

The Committee deems that the clinical benefit of FLUAD TETRA influenza vaccine (surface antigen, inactivated, adjuvanted) is substantial in the prophylaxis of influenza in people aged 65 years and over for whom influenza vaccination is recommended.

Clinical Added Value

no clinical added value

Considering, on the one hand:

the immunogenicity induced by FLUAD TETRA influenza vaccine (surface antigen, inactivated, adjuvanted) non-inferior to that of the adjuvanted trivalent (aTIV) vaccines not marketed in France against four influenza strains, with a better immune response to the additional strain B, and a satisfactory safety profile;
data from the literature relative to clinical experience with adjuvanted trivalent (aTIV) influenza vaccines suggesting a superior efficacy to that of non-adjuvanted trivalent vaccines but comparable to that of high-dose trivalent vaccines;

but considering, on the other hand:

the lack of demonstration of the efficacy of FLUAD TETRA for the prevention of influenza cases (strains A and/or B) confirmed by RT-PCR in adults aged 65 years or more in the V118_18 study, and
the absence of comparative clinical efficacy data for FLUAD TETRA versus the standard-dose or high-dose tetravalent vaccines marketed in France,

the Transparency Committee considers that FLUAD TETRA influenza vaccine (surface antigen, inactivated, adjuvanted) provides no clinical added value (CAV V) in the active immunisation of people aged 65 years and over for the prevention of influenza compared to the other available vaccines indicated in this population.