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Vaccine-Preventable Disease Incidence Based on Clinically, Radiologically, and Etiologically Confirmed Outcomes: Systematic Literature Review and Re-analysis of Pneumococcal Conjugate Vaccine Efficacy Trials.
- Source :
-
Clinical Infectious Diseases . 4/15/2022, Vol. 74 Issue 8, p1362-1371. 10p. - Publication Year :
- 2022
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Abstract
- Background Vaccine regulatory decision making is based on vaccine efficacy against etiologically confirmed outcomes, which may underestimate the preventable disease burden. To quantify this underestimation, we compared vaccine-preventable disease incidence (VPDI) of clinically defined outcomes with radiologically/etiologically confirmed outcomes. Methods We performed a systematic review of efficacy trials for several vaccines (1997–2019) and report results for pneumococcal conjugate vaccines. Data were extracted for outcomes within a clinical syndrome, organized from most sensitive to most specific. VPDI was determined for each outcome, and VPDI ratios were calculated, with a clinically defined outcome (numerator) and a radiologically/etiologically confirmed outcome (denominator). Results Among 9 studies, we calculated 27 VPDI ratios; 24 had a value >1. Among children, VPDI ratios for clinically defined versus vaccine serotype otitis media were 0.6 (95% CI not calculable), 2.1 (1.5–3.0), and 3.7 (1.0–10.2); the VPDI ratios comparing clinically defined with radiologically confirmed pneumonia ranged from not calculable to 2.7 (1.2–10.4); the VPDI ratio comparing clinically suspected invasive pneumococcal disease (IPD) with laboratory-confirmed IPD was 3.8 (95% CI not calculable). Among adults, the ratio comparing clinically defined with radiologically confirmed pneumonia was 1.9 (−6.0 to 9.1) and with vaccine serotype–confirmed pneumonia was 2.9 (.5–7.8). Conclusions While there is substantial uncertainty around individual point estimates, there is a consistent trend in VPDI ratios, most commonly showing under-ascertainment of 1.5- to 4-fold, indicating that use of clinically defined outcomes is likely to provide a more accurate estimate of a pneumococcal conjugate vaccine's public health value. [ABSTRACT FROM AUTHOR]
- Subjects :
- *STREPTOCOCCAL disease prevention
*PNEUMONIA
*ONLINE information services
*CONFIDENCE intervals
*MEDICAL information storage & retrieval systems
*SYSTEMATIC reviews
*PNEUMOCOCCAL vaccines
*STREPTOCOCCAL diseases
*VACCINE effectiveness
*INFECTION
*TREATMENT effectiveness
*SEROTYPES
*DESCRIPTIVE statistics
*MEDLINE
*OTITIS media
*EVALUATION
Subjects
Details
- Language :
- English
- ISSN :
- 10584838
- Volume :
- 74
- Issue :
- 8
- Database :
- Academic Search Index
- Journal :
- Clinical Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 156584897
- Full Text :
- https://doi.org/10.1093/cid/ciab649