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. |
English version
Contact Us
Évaluation des médicaments