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Clinical Infectious Diseases : An... Apr 2022Vaccine regulatory decision making is based on vaccine efficacy against etiologically confirmed outcomes, which may underestimate the preventable disease burden. To...
Vaccine-Preventable Disease Incidence Based on Clinically, Radiologically, and Etiologically Confirmed Outcomes: Systematic Literature Review and Re-analysis of Pneumococcal Conjugate Vaccine Efficacy Trials.
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.
Topics: Adult; Child; Humans; Incidence; Infant; Pneumococcal Infections; Pneumococcal Vaccines; Randomized Controlled Trials as Topic; Vaccine Efficacy; Vaccine-Preventable Diseases; Vaccines, Conjugate
PubMed: 34313721
DOI: 10.1093/cid/ciab649 -
The Cochrane Database of Systematic... Jul 2018Cough is a frequent symptom presenting to doctors. The most common cause of childhood chronic (greater than fours weeks' duration) wet cough is protracted bacterial... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cough is a frequent symptom presenting to doctors. The most common cause of childhood chronic (greater than fours weeks' duration) wet cough is protracted bacterial bronchitis (PBB) in some settings, although other more serious causes can also present this way. Timely and effective management of chronic wet or productive cough improves quality of life and clinical outcomes. Current international guidelines suggest a course of antibiotics is the first treatment of choice in the absence of signs or symptoms specific to an alternative diagnosis. This review sought to clarify the current evidence to support this recommendation.
OBJECTIVES
To determine the efficacy of antibiotics in treating children with prolonged wet cough (excluding children with bronchiectasis or other known underlying respiratory illness) and to assess risk of harm due to adverse events.
SEARCH METHODS
We undertook an updated search (from 2008 onwards) using the Cochrane Airways Group Specialised Register, Cochrane Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trials registries, review articles and reference lists of relevant articles. The latest searches were performed in September 2017.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing antibiotics with a placebo or a control group in children with chronic wet cough. We excluded cluster and cross-over trials.
DATA COLLECTION AND ANALYSIS
We used standard methods as recommended by Cochrane. We reviewed results of searches against predetermined criteria for inclusion. Two independent review authors selected, extracted and assessed the data for inclusion. We contacted authors of eligible studies for further information as needed. We analysed data as 'intention to treat.'
MAIN RESULTS
We identified three studies as eligible for inclusion in the review. Two were in the previous review and one new study was included. We considered the older studies to be at high or unclear risk of bias whereas we judged the newly included study at low risk of bias. The studies varied in treatment duration (from 7 to 14 days) and the antibiotic used (two studies used amoxicillin/clavulanate acid and one used erythromycin).We included 190 children (171 completed), mean ages ranged from 21 months to six years, in the meta-analyses. Analysis of all three trials (190 children) found that treatment with antibiotics reduced the proportion of children not cured at follow-up (primary outcome measure) (odds ratio (OR) 0.15, 95% confidence interval (CI) 0.07 to 0.31, using intention-to -treat analysis), which translated to a number needed to treat for an additional beneficial outcome (NNTB) of 3 (95% CI 2 to 4). We identified no significant heterogeneity (for both fixed-effect and random-effects model the I² statistic was 0%). Two older trials assessed progression of illness, defined by requirement for further antibiotics (125 children), which was significantly lower in the antibiotic group (OR 0.10, 95% CI 0.03 to 0.34; NNTB 4, 95% CI 3 to 5). All three trials (190 children) reported adverse events, which were not significantly increased in the antibiotic group compared to the control group (OR 1.88, 95% CI 0.62 to 5.69). We assessed the quality of evidence GRADE rating as moderate for all outcome measures, except adverse events which we assessed as low quality.
AUTHORS' CONCLUSIONS
Evidence suggests antibiotics are efficacious for the treatment of children with chronic wet cough (greater than four weeks) with an NNTB of three. However, antibiotics have adverse effects and this review reported only uncertainty as to the risk of increased adverse effects when they were used in this setting. The inclusion of a more robust study strengthened the previous Cochrane review and its results.
Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Child; Child, Preschool; Chronic Disease; Cough; Disease Progression; Erythromycin; Humans; Infant; Intention to Treat Analysis; Randomized Controlled Trials as Topic; Sputum
PubMed: 30062732
DOI: 10.1002/14651858.CD004822.pub3 -
Vaccine Mar 2022Patients with inflammatory bowel disease (IBD) have a high risk for infection. Pneumonia related to influenza and pneumococcal infection is one of the most common... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Patients with inflammatory bowel disease (IBD) have a high risk for infection. Pneumonia related to influenza and pneumococcal infection is one of the most common infection-related complications in IBD.
AIMS
To evaluate the immunogenicity of pneumococcal and influenza vaccination in patients with IBD receiving different treatments.
METHODS
We searched four databases for studies evaluating seroprotection and seroconversion rates after influenza or pneumococcal vaccination in IBD on 20th October 2020. In the meta-analysis, odds ratios (OR) were calculated with 95% confidence intervals (CI).
RESULTS
We included twelve studies (1429 patients with IBD) in this meta-analysis. The seroconversion rate after pneumococcal vaccination and the seroprotection rate after influenza vaccination were not significantly lower in patients receiving conventional immunosuppressive treatment compared to the non-immunosuppressed patients. Meanwhile, the seroconversion rate following pneumococcal vaccine was significantly lower in patients with anti-TNF mono- or combination therapy (OR = 0.28, CI: 0.15-0.53, and OR = 0.27, CI: 0.15-0.49, respectively). In the analysis of patients with IBD on conventional immunosuppressive monotherapy versus anti-TNF therapy, the seroprotection rate after influenza immunization did not differ between patients receiving either anti-TNF mono-or combination therapy (OR = 1.45, CI: 0.62-3.38 and OR = 0.91, CI: 0.37-2.22, respectively).
CONCLUSION
Our data suggest that the immunization against Pneumococcus and influenza is safe and immunogenic despite immunosuppression.
Topics: Adult; Humans; Immunity; Immunosuppressive Agents; Inflammatory Bowel Diseases; Influenza Vaccines; Influenza, Human; Pneumococcal Vaccines; Streptococcus pneumoniae; Tumor Necrosis Factor Inhibitors; Vaccination
PubMed: 35227523
DOI: 10.1016/j.vaccine.2022.02.027 -
Vaccine Oct 2019Serotype 3 pneumococcal disease has not substantially declined at the population level after the routine introduction of 13-valent pneumococcal conjugate vaccine (PCV13)...
BACKGROUND
Serotype 3 pneumococcal disease has not substantially declined at the population level after the routine introduction of 13-valent pneumococcal conjugate vaccine (PCV13) into pediatric immunization programs across the globe. This epidemiological finding has generated debate regarding the effectiveness of PCV13 against serotype 3 disease. Evaluating PCV13 effectiveness against serotype 3 is especially critical in adults, where serotype 3 makes up an important amount of remaining pneumococcal disease.
METHODS
We performed a systematic review of the published literature to assess the direct effectiveness of PCV13 against serotype 3 community-acquired pneumonia (CAP) among adults. We then estimated overall vaccine effectiveness (VE) using a pooled analysis of the individual-level, raw data.
RESULTS
Two published studies met inclusion criteria. One was a randomized controlled trial conducted in the Netherlands and published in 2014. The other was a recently-published case-control study conducted in Louisville, Kentucky that used a test-negative design (TND). We also identified a third TND study conducted in Argentina that was recently presented as a conference abstract but is not yet published. All three studies were conducted in adults aged ≥65 years. PCV13 VE against serotype 3 hospitalized CAP was 52.5% (95%CI: 6.2-75.9%) from the pooled analysis of individual-level data from all three studies. Results were similar if the unpublished estimate was excluded (serotype 3 VE = 53.6% [95%CI: 6.7-76.9%]). No heterogeneity was observed.
CONCLUSIONS
Currently-available evidence, although limited to three studies, suggests that PCV13 provides direct protection against serotype 3 hospitalized CAP in adults aged ≥65 years.
Topics: Adult; Argentina; Case-Control Studies; Humans; Kentucky; Netherlands; Pneumococcal Infections; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Randomized Controlled Trials as Topic; Research Design; Serogroup; Streptococcus pneumoniae; Vaccine Potency; Vaccines, Conjugate
PubMed: 31522807
DOI: 10.1016/j.vaccine.2019.08.059 -
Human Vaccines & Immunotherapeutics Nov 2022National Immunization Technical Advisory Groups (NITAGs) and Health Technology Assessment (HTA) agencies evaluate the value of vaccines and provide decision-making...
National Immunization Technical Advisory Groups (NITAGs) and Health Technology Assessment (HTA) agencies evaluate the value of vaccines and provide decision-making authorities with recommendations. The availability of information on disease-burden evidence considered or required for the assessment of vaccines included in national immunization programs (NIPs) is limited. The aim of this review is to summarize the epidemiologic and health economic (HE) evidence considered by NITAGs/HTA agencies when evaluating pediatric pneumococcal conjugate vaccine (PCV) NIPs. A systematic literature review of national recommendation reports for PCV NIPs in children in 31 European countries, published since 2001, was performed using NITAG/HTA agency websites, Google, MEDLINE, and EMBASE. The presence of epidemiological data was mapped, HE data was extracted, and findings were summarized. A total of 46 records for 19 countries were identified. Fifteen countries' records included a recommendation concerning implementation of PCV NIP, switching from one PCV to another or a change in vaccination schedule within an existing NIP. All of these included epidemiological invasive pneumococcal disease data, and to varying degree epidemiological data on acute otitis media and pneumonia. HE data was referenced in 13 countries' records, with 8 countries providing in-depth details on cost-effectiveness analyses. Pediatric PCV NIP recommendations were published by 61% of European countries, with varying degree of details and decision rationale. Some countries only publish the HE aspect of their rationale. The identified material can provide insight and support local policymakers and clinicians how data influenced the decision-making process in their countries.
Topics: Child; Europe; Humans; Immunization Programs; Pneumococcal Infections; Pneumococcal Vaccines; Technology Assessment, Biomedical; Vaccination; Vaccines, Conjugate
PubMed: 35438039
DOI: 10.1080/21645515.2022.2060017 -
PloS One 2024Invasive pneumococcal diseases (IPD) are associated with high morbidity, mortality, and health costs worldwide, particularly in Latin America and the Caribbean (LAC).... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Invasive pneumococcal diseases (IPD) are associated with high morbidity, mortality, and health costs worldwide, particularly in Latin America and the Caribbean (LAC). Surveillance about the distribution of serotypes causing IPD and the impact of pneumococcal vaccination is an important epidemiological tool to monitor disease activity trends, inform public health decision-making, and implement relevant prevention and control measures.
OBJECTIVES
To estimate the serotype distribution for IPD and the related disease burden in LAC before, during, and after implementing the pneumococcal vaccine immunization program in LAC.
METHODS
Systematic literature review following Cochrane methods of studies from LAC. We evaluated the impact of the pneumococcal vaccine on hospitalization and death during or after hospitalizations due to pneumococcal disease and serotype-specific disease over time. We also analyzed the incidence of serotyped IPD in pneumococcal conjugate vaccine PCV10 and PCV13. The protocol was registered in PROSPERO (ID: CRD42023392097).
RESULTS
155 epidemiological studies were screened and provided epidemiological data on IPD. Meta-analysis of invasive diseases in children <5 years old found that 57%-65% of causative serotypes were included in PCV10 and 66%-84% in PCV13. After PCV introduction, vaccine serotypes declined in IPD, and the emergence of non-vaccine serotypes varied by country.
CONCLUSIONS
Pneumococcal conjugate vaccines significantly reduced IPD and shifted serotype distribution in Latin America and the Caribbean. PCV10/PCV13 covered 57-84% of serotypes in children under 5, with marked decline in PCV serotypes post-vaccination. Continuous surveillance remains crucial for monitoring evolving serotypes and informing public health action.
Topics: Humans; Latin America; Caribbean Region; Pneumococcal Infections; Pneumococcal Vaccines; Serogroup; Streptococcus pneumoniae; Vaccination; Cost of Illness; Incidence
PubMed: 38935748
DOI: 10.1371/journal.pone.0304978 -
Human Vaccines & Immunotherapeutics Nov 2022Globally, an estimated 23 million children missed vaccination in 2020 due to the coronavirus disease 2019 (COVID-19) pandemic. We analyzed vaccination coverage trends...
Globally, an estimated 23 million children missed vaccination in 2020 due to the coronavirus disease 2019 (COVID-19) pandemic. We analyzed vaccination coverage trends and catch-up strategies/recommendations implemented in Latin America during the pandemic. We performed a national administrative database analysis and a systematic literature review to evaluate vaccination coverage data and identify catch-up strategies for missed vaccinations in selected countries in Latin America (Argentina, Brazil, Chile, Colombia, Mexico and Peru). Data were extracted from national health ministry vaccination coverage and supranational databases to identify coverage of rotavirus (RV), pentavalent/hexavalent, measles, Bacillus Calmette-Guérin (BCG) and pneumococcal conjugate vaccines (PCV) at country level before and during the COVID-19 pandemic. A systematic literature review of published papers was conducted to identify vaccination catch-up strategies published in January 2020-June 2021. National administrative database-reported data showed that vaccination coverage trends were declining prior to 2020. The change in vaccination coverage before and during the COVID-19 pandemic ranged from 2.5% to -11.5% (RV), -3.0% to -11.0% (measles), 1.5% to -7.5% (PCV), 9.0% to -14.0% (pentavalent/hexavalent), and 3.0% to -18.5% (BCG). Among 696 identified studies, 14 studies were included in this review. Catch-up vaccination strategies included prioritizing routine vaccinations as per the national immunization schedule. Overall vaccination coverage declined by varying degrees among the countries investigated. This trend was observed prior to 2020, suggesting multifactorial reasons for declining vaccination rates in Latin America.
Topics: Child; Humans; Pandemics; COVID-19; Vaccination; Immunization Schedule; Measles; Vaccines, Conjugate; Immunization Programs
PubMed: 36084255
DOI: 10.1080/21645515.2022.2102353 -
Antibiotics (Basel, Switzerland) Jan 2024causes serious illnesses, such as pneumonia, bacteremia, and meningitis, mainly in immunocompromised individuals and those of extreme ages. Currently, pneumococcal... (Review)
Review
causes serious illnesses, such as pneumonia, bacteremia, and meningitis, mainly in immunocompromised individuals and those of extreme ages. Currently, pneumococcal conjugate vaccines (PCVs) are the best allies against pneumococcal diseases. In Brazil, the 10-valent and 13-valent PCVs have been available since 2010, but the threat of antimicrobial resistance persists and has been changing over time. We conducted a systematic review of the literature with works published since 2000, generating a parallel between susceptibility data on isolates recovered from colonization and invasive diseases before and after the implementation of PCVs for routine childhood use in Brazil. This systematic review was based on the Cochrane Handbook for Systematic Reviews of Interventions and Preferred Reporting Items for Systematic Literature Reviews and Meta-Analyses (PRISMA) guidelines. Despite the inclusion of PCVs at a large scale in the national territory, high frequencies of non-susceptibility to important drugs used in pneumococcal diseases are still observed, especially penicillin, as well as increasing resistance to macrolides. However, there are still drugs for which pneumococci have a comprehensive sensitivity profile.
PubMed: 38247625
DOI: 10.3390/antibiotics13010066 -
Vaccine Apr 2024The cross-protection of pneumococcal conjugate vaccines (PCV) against serotype 6C is not clearly documented, although 6C represents a substantial burden of pneumococcal...
BACKGROUND
The cross-protection of pneumococcal conjugate vaccines (PCV) against serotype 6C is not clearly documented, although 6C represents a substantial burden of pneumococcal disease in recent years. A systematic review by the World Health Organization that covered studies through 2016 concluded that available data were insufficient to determine if either PCV10 (which contains serotype 6B but not 6A) or PCV13 (containing serotype 6A and 6B) conferred protection against 6C.
METHODS
We performed a systematic review of randomized controlled trials and observational studies published between January 2010 - August 2022 (Medline/Embase), covering the direct, indirect, and overall effect of PCV10 and PCV13 against 6C invasive pneumococcal disease (IPD), non-IPD, nasopharyngeal carriage (NPC), and antimicrobial resistance (AMR).
RESULTS
Of 2548 publications identified, 112 were included. Direct vaccine effectiveness against 6C IPD in children ranged between 70 and 85 % for ≥ 1 dose PCV13 (n = 3 studies), was 94 % in fully PCV13 vaccinated children (n = 2), and -14 % for ≥ 1 dose of PCV10 (n = 1). Compared to PCV7, PCV13 efficacy against 6C NPC in children was 66 % (n = 1). Serotype 6C IPD rates or NPC prevalence declined post-PCV13 in most studies in children (n = 5/6) and almost half of studies in adults (n = 5/11), while it increased post-PCV10 for IPD and non-IPD in all studies (n = 6/6). Changes in AMR prevalence were inconsistent.
CONCLUSIONS
In contrast to PCV10, PCV13 vaccination consistently protected against 6C IPD and NPC in children, and provided some level of indirect protection to adults, supporting that serotype 6A but not 6B provides cross-protection to 6C. Vaccine policy makers and regulators should consider the effects of serotype 6A-containing PCVs against serotype 6C disease in their decisions.
Topics: Child; Adult; Humans; Infant; Anti-Bacterial Agents; Serogroup; Drug Resistance, Bacterial; Streptococcus pneumoniae; Pneumococcal Vaccines; Pneumococcal Infections; Vaccines, Conjugate
PubMed: 38553292
DOI: 10.1016/j.vaccine.2024.03.065 -
Vaccine Oct 2017This systematic review and meta-analysis aimed at summarizing available data on the impact of PCV10 and PCV13 in reducing the incidence of CAP hospitalizations in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This systematic review and meta-analysis aimed at summarizing available data on the impact of PCV10 and PCV13 in reducing the incidence of CAP hospitalizations in children aged <5years.
METHODS
A systematic search of the literature was conducted. We included time-series analyses and before-after studies, reporting the incidence of hospitalization for pneumonia in the periods before and after the introduction of PCV10 or PCV13 into the immunization program. Pooled estimates of Incidence Rate Ratio (IRR) were calculated by using a random-effects meta-analytic model. Results were stratified according to age-groups (<24months and 24-59months) and case definitions of pneumonia (clinically and radiologically confirmed pneumonia).
RESULTS
A total of 1533 potentially relevant articles were identified. Of these, 12 articles were included in the analysis. In children aged <24months, the meta-analysis showed a reduction of 17% (95%CI: 11-22%, p-value<0.001) an of 31% (95%CI: 26-35%, p-value<0.001) in the hospitalization rates respectively for clinically and radiologically confirmed pneumonia, respectively, after the introduction of the novel PCVs. In children aged 24-59months, the meta-analysis showed a reduction of 9% (95%CI: 5-14%, p-value<0.001) and of 24% (95%CI: 12-33%, p-value<0.001) in the hospitalization rates for clinically and radiologically confirmed pneumonia, respectively, after the introduction of the novel PCVs. High heterogeneity was detected among studies evaluating the hospitalization rate for clinically and radiologically confirmed pneumonia.
CONCLUSIONS
The results of this study revealed a significant impact of PCV10 and PCV13 in reducing the hospitalizations for pneumonia, particularly in children aged <24months and for radiologically confirmed disease. Further appropriately designed studies, comparing the impact of PCV10 and PCV13, are needed in order to obtain solid data on which to establish future immunization strategies.
Topics: Child, Preschool; Hospitalization; Humans; Infant; Infant, Newborn; Pneumococcal Infections; Pneumococcal Vaccines; Pneumonia, Pneumococcal; Streptococcus pneumoniae; Vaccination
PubMed: 28911902
DOI: 10.1016/j.vaccine.2017.09.005