INFLUVAC TETRA, tetravalent vaccine against seasonal influenza

INFECTIOUS DISEASES - New medicinal product

Opinions on drugs - Posted on May 25 2018

Reason for request

Inclusion

Substantial actual benefit in prevention of influenza, but no clinical benefit over inactivated trivalent vaccines

INFLUVAC TETRA is an injectable vaccine that has Marketing Authorisation in active immunisation for prevention of influenza caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.
It differs from trivalent influenza vaccines by the addition of a second type B strain.
In France, two other injectable quadrivalent influenza vaccines already have Marketing Authorisation in adults and children aged 3 years or over: FLUARIXTETRA and VAXIGRIPTETRA. Unlike these vaccines, INFLUVAC TETRA is only indicated in adults.

Clinical Benefit

Substantial

Le service médical rendu par INFLUVAC TETRA est important dans la prévention de la grippe chez les adultes à partir de 18 ans, uniquement dans les populations pour lesquelles la vaccination grippale est recommandée.

Clinical Added Value

no clinical added value

Au vu des données disponibles, la Commission considère qu’INFLUVAC TETRA n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux vaccins trivalents inactivés disponibles indiqués dans la prévention de la grippe (cf. paragraphe 07), dans les populations recommandées.