Favourable opinion for reimbursement for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older in accordance with the current official recommendations of 15 April 2024 relative to cholera anticipation and management measures in Mayotte.
Clinical Benefit
Substantial
The clinical benefit of VAXCHORA (cholera vaccine (recombinant, live, oral)) is substantial in the active immunisation against diease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older in accordance with the current HCSP recommendations of 15 April 2024 relative to cholera anticipation and management measures in Mayotte.
Clinical Added Value
no clinical added value
Considering:
the need to reinforce the vaccine offer given the major requirement for access to cholera vaccines in Mayotte;
the current HCSP recommendations of 15 April 2024 relative to cholera anticipation and management measures in Mayotte,
available data suggesting an efficacy of around 90.3% at D11 and 79.5% at D91 in individuals aged 18 to 45 years in terms of reduction in the incidence of moderate to severe diarrhoea;
immunogenicity data supporting these results in individuals aged 46 to 64 years and in individuals aged 2 to 18 years;
the satisfactory safety profile, marked primarily by fatigue and headaches;
the obvious advantage of using a vaccine with a one-dose regimen, particularly in an epidemic context;
but:
the absence of clinical data having compared the efficacy of the DUKORAL vaccine (inactivated cholera vaccine, oral), which is an inactivated vaccine available in France;
the contraindication in immunosuppressed individuals and their families due to a vaccine strain excretion duration that is still unknown;
the impossibility of using it in the event of the post-exposure antibiotic prophylaxis necessary for individuals living in the same household as an identified case;
the lack of data on the protection duration,
the Transparency Committee deems that VAXCHORA (cholera vaccine (recombinant, live, oral)) provides no clinical added value (CAV V) in the preventive strategy including DUKORAL (inactivated cholera vaccine, oral), for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older in accordance with the current official recommendations of 15 April 2024 relative to cholera anticipation and management measures in Mayotte
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