CAPVAXIVE ((pneumococcal polysaccharide conjugate vaccine, 21-valent) - Pneumococcal infections

The clinical benefit of CAPVAXIVE (pneumococcal polysaccharide conjugate vaccine, 21-valent), is substantial for active immunisation for the prevention of invasive infections and pneumonia caused by Streptococcus pneumoniae in people aged 18 and over, according to the HAS guidelines in force dated 3 July 2025.

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 CAPVAXIVE (pneumococcal polysaccharide conjugate vaccine, 21-valent) compared with PREVENAR 20 (pneumococcal polysaccharide conjugate vaccine, 20-valent, adsorbed) in terms of geometric mean titres of opsonophagocytic activity (GMT OPA) for the 10 shared serotypes covered by both vaccines;
• the superiority of the immune response induced by CAPVAXIVE (pneumococcal polysaccharide conjugate vaccine, 21-valent) over PREVENAR 20 (pneumococcal polysaccharide conjugate vaccine, 20-valent, adsorbed) in terms of geometric mean titres of opsonophagocytic activity (GMT OPA) for 10 of the 11 single serotypes (9N, 15A, 16F, 17F, 20, 23A, 23B, 24F, 31 and 35B) covered by CAPVAXIVE (pneumococcal polysaccharide conjugate vaccine, 21-valent);

• data relative to coadministration with a quadrivalent seasonal influenza vaccine (QIV), showing non-inferiority of concomitant administration of QIV and PCV 21 compared with sequential administration of these same vaccines, in terms of GMT HAI (haemagglutination inhibition) 30 days after vaccination, for three of the four QIV strains except for the A/H3N2 strain;

• a favourable safety profile;

however, in view of:

• a potential additional impact on the reduction of morbidity and mortality as a result of the addition of 11 additional serotypes (9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31 and 35B) compared with PREVENAR 20, which cannot be assessed in the absence of clinical efficacy data, with a lack of coverage of 10 serotypes currently covered by PREVENAR 20 (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 5, 15B);

the clinical benefit of CAPVAXIVE (pneumococcal polysaccharide conjugate vaccine, 21-valent), is substantial for active immunisation for the prevention of invasive infections and pneumonia caused by Streptococcus pneumoniae in people aged 18 and over, according to the HAS guidelines in force dated 3 July 2025.