The Committee deems that the clinical benefit of VIVOTIF (typhoid vaccine, Ty21a), gastro-resistant capsule, is substantial for active oral immunisation against typhoid fever caused by Salmonella enterica serovar typhi (S. typhi) in adults and children aged 5 years and over, according to the HAS guidelines in force of February 2020.
Clinical Added Value
no clinical added value
In view of:
the data in endemic areas available and taken into account by the HAS guidelines of February 2020, which suggest similar efficacy and safety to the other Vi polysaccharide vaccines available in adults, adolescents and children aged over 5 years;
and its oral gastro-resistant capsule form which expands the therapeutic range, on account of the lack of needle use which may have a potential positive impact on vaccination coverage;
but:
the risk of misuse which cannot be ruled out in view of repeated administration in 3 doses (D1, D3 and D5) which entails, to obtain optimal protection, self-administration and good compliance by individuals;
the lack of robust comparative data in relation to the other Vi polysaccharide vaccines available, in particular in terms of acceptability and/or compliance;
the Committee deems that VIVOTIF (typhoid fever, Ty21a), gastro-resistant capsule, provides no clinical added value (CAV V) for active oral immunisation against typhoid fever caused by Salmonella enterica serovar typhi (S. typhi) in adults and children aged 5 years and over, according to the HAS guidelines in force of February 2020.
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