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Pneumococcal serotypes missing prespecified efficacy threshold in immunogenicity trials: real-world evidence from national immunization programs.
- Source :
-
Expert review of vaccines [Expert Rev Vaccines] 2024 Jan-Dec; Vol. 23 (1), pp. 879-886. Date of Electronic Publication: 2024 Oct 09. - Publication Year :
- 2024
-
Abstract
- Objectives: The 13-valent (PCV13) and 10-valent (PCV10) pneumococcal conjugate vaccines missed non-inferiority for certain 7-valent (PCV7) serotypes in immunogenicity trials. This study examines the population-level IPD case trends for these serotypes.<br />Methods: We identified six countries with national IPD surveillance data that introduced PCV13 (Canada, Germany, Israel, Italy, South Africa, and the United States) and three with PCV10 (Finland, Brazil, and the Netherlands). We extracted country-specific annual IPD case counts for PCV7 serotypes that missed non-inferiority and met non-inferiority (6B + 23F and PCV7 minus [6B + 23F] serotypes for PCV10 countries; 6B +9V + 23F, and PCV7 minus [6B +9V + 23F] serotypes for PCV13 countries) in clinical trials. Case count data for each country were plotted for observed serotype trends in different age groups (<5 and ≥5 years) for 8 years following PCV13/PCV10 introduction.<br />Results: For all ages and countries, IPD cases due to PCV7 serotypes that missed non-inferiority either decreased or remained suppressed following PCV13/PCV10 introduction. Similar trends were found for PCV7 serotypes that met non-inferiority in those <5 years. Paradoxically, cases increased in those ≥5 years in Canada, Italy, and the US, primarily driven by increases in serotypes 4 and 19F disease.<br />Conclusions: Despite missing non-inferiority of serotypes in immunogenicity trials, higher-valent PCVs effectively suppressed these serotypes across all ages. Non-inferiority criteria from immunogenicity trials may not fully predict real-world disease impact after PCV implementation.
- Subjects :
- Humans
Child, Preschool
Infant
Heptavalent Pneumococcal Conjugate Vaccine immunology
Heptavalent Pneumococcal Conjugate Vaccine administration & dosage
Immunogenicity, Vaccine
Canada
Pneumococcal Vaccines immunology
Pneumococcal Vaccines administration & dosage
Serogroup
Pneumococcal Infections prevention & control
Pneumococcal Infections immunology
Streptococcus pneumoniae immunology
Streptococcus pneumoniae classification
Immunization Programs
Subjects
Details
- Language :
- English
- ISSN :
- 1744-8395
- Volume :
- 23
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Expert review of vaccines
- Publication Type :
- Academic Journal
- Accession number :
- 39329476
- Full Text :
- https://doi.org/10.1080/14760584.2024.2409662