TRUMENBA Meningococcal group B vaccine (recombinant, adsorbed)
Reason for request
Key points
Favourable opinion for reimbursement in the active immunisation to prevent invasive meningococcal disease caused by serogroup B strains, in individuals 10 years and older, only in the populations recommended by the HAS on 3 June 2021.
What therapeutic improvement?
No therapeutic improvement compared to BEXSERO in the prevention of invasive meningococcal disease caused by serogroup 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 serogroup 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 TRUMENBA, meningococcal group B vaccine (recombinant, adsorbed) should be used in accordan ce with its MA and in accordance with current vaccination recommendations for the prevention of invasive meningococcal disease caused by serogroup B strains in high-risk individuals 10 years and older.
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 TRUMENBA is substantial in the active immunisation against invasive meningococcal disease caused by serogroup B strains, in individuals 10 years and older, in the populations recommended by the HAS on 3 June 2021. |
Clinical Added Value
no clinical added value |
Considering:
But,
the Committee considers that TRUMENBA, meningococcal group B vaccine (recombinant, adsorbed) provides no clinical added value (CAV V) in the prevention of invasive meningococcal disease caused by serogroup B strains, compared to BEXSERO (meningococcal group B vaccine).
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