Effectiveness and impact of the 10-valent pneumococcal conjugate vaccine, PHiD-CV: review of clinical trials and post-marketing experience

Abstract

Pneumococcal diseases (including septicemia, meningitis, pneumonia, and upper respiratory infections) constitute a major public health problem. The World Health Organization recommends pneumococcal conjugate vaccine immunization of young children worldwide. Areas covered: We reviewed evidence on the effects of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV), which is used in childhood immunization programs in over 45 countries or regions. The effectiveness of PHiD-CV against invasive pneumococcal disease (IPD), pneumonia, and acute otitis media was assessed. We also present its effect on pneumococcal nasopharyngeal carriage (NPC) and indirect effects (herd protection) among unvaccinated individuals. Expert commentary: Results from randomized, double-blind trials and post-marketing studies in various countries provide evidence of the protective efficacy, effectiveness, and impact of PHiD-CV against pneumococcal diseases. Data from different geographic locations also show reductions in NPC of vaccine pneumococcal serotypes, laying the foundation for indirect protection against pneumococcal disease. In countries where PHiD-CV is included in childhood immunization programs, there are signs of herd protection for vaccine serotypes among unvaccinated individuals. Although increases in non-vaccine serotype IPD and NPC rates were observed, there was an overall reduction of pneumococcal disease.

Vaccination against Paediatric Respiratory Pathogens

“…It was protected against 7 pneumococcal serotypes, considerably fewer than the total number of infective pneumococcal serotypes that circulate [67]. Moreover, the composition of PCV7 was based on serotypes that most commonly caused invasive pneumococcal disease (IPD) in the USA [67]. However, other serotypes isolated more frequently in other countries meant PCV7 could be less effective than expected in some geographic areas.…”

“…Its introduction in Europe followed in 2001. With the development of PCVs, a new era in the prevention of infections due to S. pneumoniae has begun [67]. However, despite being able to significantly reduce pneumococcal disease incidence, the first PCV, the heptavalent preparation (PCV7), quickly exhibited limitations.…”

“…However, despite being able to significantly reduce pneumococcal disease incidence, the first PCV, the heptavalent preparation (PCV7), quickly exhibited limitations. It was protected against 7 pneumococcal serotypes, considerably fewer than the total number of infective pneumococcal serotypes that circulate [67]. Moreover, the composition of PCV7 was based on serotypes that most commonly caused invasive pneumococcal disease (IPD) in the USA [67].…”

Development of Next Generation Streptococcus pneumoniae Vaccines Conferring Broad Protection

“…Unfortunately, the prevention of acute otitis media caused by serotypes included in PCV remained moderate to low [47,48]. PHiD-CV was shown to be more effective in preventing acute otitis media than PCV7 [38,49].…”

“…PHiD-CV vaccination was associated with a delayed, relatively lower increase in the non-vaccine-type carriage in clinical studies. However, the problem of serotype replacement still existed and was not eliminated with the administration of PHiD-CV [38]. In addition, geographical differences in serotype distribution have led to reduced effectiveness of the vaccines when they were implemented in geographic areas where the serotypes were not covered by the vaccines [21].…”