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FLUENZ TETRA, tetravalent vaccine against seasonal influenza in children

INFECTIOLOGY - NEW MEDICINAL PRODUCT
Opinions on drugs - Posted on Sep 17 2015

Reason for request

Inclusion

No clinical benefit demonstrated in the influenza prevention strategy

 

  • FLUENZ TETRA is a live attenuated, nasal vaccine with Marketing Authorisation in the prevention of influenza in children and adolescents aged between 24 months and 18 years.
  • This is the first approved vaccine containing four influenza vaccine strains, two of type A (H1N1 and H3N2) and two of type B (Yamagata and Victoria), i.e. an additional type B strain compared with the available trivalent influenza vaccines.
  • No clinical benefit over other vaccines has been demonstrated as a result of this addition.
  • The immunogenicity of FLUENZ TETRA is non-inferior to that of the trivalent formulation FLUENZ.
  • The addition of a second virus B strain is not expected to benefit public health.

Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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