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BEXSERO (vaccin méningococcique groupe B (ADNr, composant, adsorbé))

Opinions on drugs - Posted on Aug 05 2021

Reason for request

Reevaluation

Key points

Favourable opinion for reimbursement in the active immunisation against invasive meningococcal disease caused by group B strains, in individuals from 2 months of age and older, only in the populations recommended by the HAS on 3 June 2021.

What therapeutic improvement?

Therapeutic improvement in the prevention of invasive meningococcal disease caused by group B strains.

Role in the care pathway?

In June 2021, the HAS drew up vaccine recommendations for the prevention of invasive meningococcal disease caused by group B strains and defined the role of the meningococcal group B vaccines: BEXSERO and TRUMENBA in the preventive strategy.

In France, for the prevention of invasive meningococcal disease, it is now recommended to perform vaccination using:

-    BEXSERO and TRUMENBA in individuals at increased risk of meningococcal disease and for targeted populations in the               context of specific situations;

-    BEXSERO in all infants from 2 months of age and older.

Role of the medicinal product in the care pathway

The Committee considers that BEXSERO (meningococcal group B vaccine) should be used in accordance with its MA and in accordance with current vaccination recommendations for the prevention of invasive meningococcal disease caused by group B strains in all infants and high-risk individuals.

The Committee highlights the fact that vaccination is the most effective tool for the prevention of meningococcal infection and associated complications (purpura fulminans). Good vaccination coverage of infants and high-risk populations is essential.

 

 


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of BEXSERO remains substantial in the active immunisation against invasive meningococcal disease caused by group B strains, in individuals from 2 months of age and older, only in the populations recommended by the HAS on 3 June 2021.


Clinical Added Value

important

The MA amendments and updating of the vaccine strategy do not modify the clinical added value, which remains important (CAV II) in the prevention of invasive meningococcal disease caused by group B strains, in the populations recommended by the HAS in 2021.

 

 


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