VAXNEUVANCE (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) - Streptococcus pneumoniae from 6 weeks to less than 18 years of age

Considering all these elements, the Committee deems that the clinical benefit of VAXNEUVANCE (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)), is substantial in the active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by pneumococcal infections in infants, children and adolescents from 6 weeks to less than 18 years of age, in accordance with the current HAS recommendations issued on 27 July 2023.

Considering:

• the medical need to expand the range of pneumococcal vaccines available based on the evolution of the epidemiological situation for infections caused by Streptococcus pneumoniae, in particular due to the emergence of new non-vaccine serotypes;
• the non-inferiority of the immune response induced by VAXNEUVANCE (pneumococcal
  polysaccharide conjugate vaccine (15-valent, adsorbed) or VPC15) compared to PREVENAR 13 (pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) or VPC13) in terms of serologic response rate and geometric mean titres of antibodies for the 13 shared serotypes covered by PREVENAR 13 (VPC13) on D30 after the last dose;
• the superiority of the immune response induced by VAXNEUVANCE (VPC15) compared to PREVENAR 13 (VPC13) in terms of serologic response rate and geometric mean titres of antibodies for the two additional serotypes (22F and 33F) on D30 after the last dose;
• data relative to coadministration with paediatric vaccines (INFANRIX HEXA, ROTARIX, RECOMBIVAX HB, ROTATEQ, PENTACEL, VAQTA, HIBERIX, MMRII and VARIVAX) having demonstrated a non-inferiority of VAXNEUVANCE (VPC15) compared to PREVENAR 13 (VPC13) in terms of immunogenicity with respect to the antigens contained in these vaccines;
• a favourable safety profile, despite being marked by a higher incidence of irritability in the VAXNEUVANCE (VPC15) group compared to the PREVENAR 13 (VPC13) group;

but,

• a potential additional impact on the reduction of morbidity and mortality as a result of the addition of two serotypes (22F and 33F) that cannot be assessed in the absence of clinical efficacy data and given the low representation of these circulating serotypes in France (22F and 33F respectively responsible for 5.13% and 1.71% of cases of bacteraemia, and 0% and 5.88% of cases of pneumococcal meningitis in 2020). It should be noted that the serotypes most frequently isolated in invasive pneumococcal infection in children under 15 years of age in 2020 were serotypes 24F, 10A and 23B, not included in anti-pneumococcal vaccines. Respectively, they account for 16.24%, 10.26% and 10.26% of cases of bacteraemia and 11.76%, 13.73% and 5.88% of meningitis;
• heterogeneous results concerning the immune response against vaccine serotype 6A on D30 after the third dose (non-inferiority endpoint not reached in the PNEU-PED study and weaker immune response in the VAXNEUVANCE group (VPC15) in the PNEU-LINK study);

the Committee deems that VAXNEUVANCE (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) provides no clinical added value (CAV V) in the active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by pneumococcal infections in infants, children and adolescents from 6 weeks to less than 18 years of age.