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EFLUELDA

Vaccine - First assessment
Opinions on drugs - Posted on Jul 01 2020

Reason for request

Inclusion

First assessment.

Favourable opinion for reimbursement in the prevention 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;
  • 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 20/05/2020 relative to the EFLUELDA vaccine, “since this vaccine induces better protection in elderly people compared to standard-dose trivalent vaccines, EFLUELDA may be used, in the same way as other influenza vaccines, in accordance with its MA, i.e., from the age of 65 years in the context of the French seasonal influenza vaccination strategy aimed at reducing serious forms and deaths. No data are available concerning other special populations, such as immunocompromised subjects or adults under the age of 65 years at risk of severe influenza and eligible for vaccination recommendations”.

Role of EFLUELDA defined by the Transparency Committee:

The Committee considers that EFLUELDA high-dose (60 µg) quadrivalent vaccine 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 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 care-givers, 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 clinical benefit of EFLUELDA is substantial in the prevention of influenza in people aged 65 years and over and for whom influenza vaccination is recommended.


Clinical Added Value

no clinical added value

Considering:

  • the immunogenicity induced by EFLUELDA (“high-dose” inactivated quadrivalent influenza vaccine) non-inferior to that of the “high dose” trivalent vaccine marketed in the USA (FLUZONE trivalent HD not available in France) against the three strains common to both vaccines, with a better immune response to the additional strain B and a satisfactory safety profile,
  • the possible benefit of a high-dose quadrivalent vaccine compared to a standard-dose quadrivalent vaccine considering the results of studies having demonstrated a clinical superiority of the high-dose trivalent vaccine (marketed in the USA) compared to standard-dose trivalent vaccines in subjects aged 65 years, with a modest relative reduction in the incidence of virologically confirmed influenza cases (24.2% [9.7% - 36.5%]) and, to a lesser degree, hospitalisations due to influenza or respiratory or cardiovascular conditions (8% to 27%) or hospitalisations for all causes (heterogeneous results), and without a demonstrated impact on either mortality or functional decline,

but in the absence comparative clinical efficacy data for EFLUELDA versus the standard-dose quadrivalent vaccines marketed in France,

the Committee considers that EFLUELDA (“high-dose” inactivated quadrivalent influenza vaccine) 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.


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