Canadian Task Force on Preventive Health Care

Structured Abstract

Please note: In 2003, the CTF updated its Grades of Recommendations to include an "I Recommendation" for situations where insufficient evidence exists to allow a recommendation to be made.  (Formerly, these situations were captured under a "C Recommendation".)  This change is not retroactive, and all "C Recommendations" made prior to 2003 have not been reevaluated in light of the new "I" recommendation grade.  For a discussion of these recommendation grades, please link to the 2003 article in the Canadian Medical Association Journal here.

Administration of Pneumococcal Vaccine
 

Prepared by Elaine E.L. Wang, MD, CM, FRCPC, Department of Pediatrics, University of Toronto

These recommendations were finalized by the Task Force in September 1990

Contents
 

 Objective

To make recommendations regarding the administration of pneumococcal vaccine to the general population and specific subgroups.

 Burden of Suffering

The annual incidence of pneumococcal pneumonia in the United States has been estimated to be between one and five episodes per 1000 subjects. One population-based study showed that pneumococcal bacteria were found in 18.7 subjects per 100,000 population, with an incidence of 53 per 100,000 among those 65 years or more. The incidence of pneumococcal pneumonia has been estimated to be three to five times this value. S. pneumoniae is a major cause of otitis media, and was responsible for 73 (37%) of the reported cases of bacterial meningitis in Canada in 1986. Those at high risk for pneumococcal infections include: patients with anatomic or functional asplenia, those with Hodgkin's disease or nephrotic syndrome, and those receiving immunosuppressive therapy. Other groups in which such infections have been associated with increased rates of illness and death include those with chronic lung or cardiac disease or diabetes mellitus, those in institutions and over age 55.

 Options

Universal immunization or immunization targeted at high-risk groups.

 Outcomes

Primary outcome was protective efficacy (PE) of the vaccine as indicated by the development of illness after exposure. In adult populations, ‘illnesses’ included pneumococcal and other types of pneumonia, bacteremia, and in pediatric populations included ear or respiratory infections. Other outcomes were death, hospital admission and serotype response.

 Evidence

MEDLINE was searched to March 1993 using the MeSH headings bacterial vaccines, pneumococcal infections and human. Study results were synthesized in table or graphic format only.

Recommendations were graded as:
A
 Good evidence to support the recommendation that the condition be specifically considered in a PHE. 
B
 Fair evidence to support the recommendation that the condition be specifically considered in a PHE. 
C
 Poor evidence regarding inclusion or exclusion of the condition in a PHE, but recommendations may be made on other grounds. 
D
 Fair evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE. 
E
 Good evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE. 
Quality of evidence was rated according to 5 levels:
I
 Evidence from at least 1 properly randomized controlled trial (RCT). 
II-1
 Evidence from well-designed controlled trials without randomization. 
II-2
 Evidence from well-designed cohort or case-control analytic studies, preferably from more than 1 centre or research group. 
II-3
 Evidence from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments could also be included here. 
III
 Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees. 

 Values

The 13-member Task Force of experts in family medicine, geriatric medicine, pediatrics, psychiatry and epidemiology used an evidence-based method for evaluating the effectiveness of preventive health care interventions. Recommendations were not based on cost-effectiveness of options. Patient preferences were not discussed.

Background papers providing critical appraisal of the evidence and tentative recommendations prepared by the chapter author were pre-circulated to the members. Evidence for this topic was presented and deliberated upon in 1- to 2-day meetings, 2 to 3 times per year from January 1993 to June 1993. Consensus was reached on final recommendations.

 Benefits, Harms, and Costs

Studies of adults report contradictory results. This is probably due to differences in study designs, populations and endpoints. Because of the low incidence of pneumococcal pneumonia in the general population, studies involving this population often have low statistical power. An RCT involving 13 600 immunocompetent individuals ³ 45 years reported no difference in radiologically-diagnosed pneumonias or isolation of pneumococci between groups receiving and not receiving the vaccine. Another RCT of 2295 at-risk patients also found no differences in mortality or illness rates. Case-control studies report protective efficacies (PEs) of 56% (95% CI 42% to 67%) to 70% (95%CI 36% to 86%) among immunocompetent patients, and 67% (95% CI 13% to 87%) for individuals at risk for pneumococcal infection. The vaccine was not efficacious for serotypes not represented in the vaccine (PE=-73%, p=0.15) or for immunocompromised patients (PE=21%, p=0.48).

Vaccine efficacy in patients with sickle cell disease, and those who have undergone splenectomy was confirmed in a cohort study. A cross-sectional study of patients >10 years reported an efficacy rate of 60% (proportions of isolates of vaccine serotypes). The vaccine was not efficacious in patients with immunologic or splenic disorders. A subsequent study reported an efficacy of 47%. A cross-sectional study found an efficacy rate of 55% (95% CI 2% to 82%) among patients with chronic cardiovascular disease, pulmonary disease or diabetes, and 61% (95% CI 3% to 99%) among those ³ 61 years.

RCTs involving general pediatric populations found no differences in vaccine and control groups in number of respiratory and otic complaints or hospital admissions.

An RCT conducted in geriatric hospitals and homes for the elderly in France found an efficacy rate of 77% (95% CI 51% to 89%) [24]. In a 6-year RCT of 11 000 inpatients >40 years, there were 99 cases of pneumonia among 5750 vaccinated patients, and 227cases among 5153 controls (p<0.001). There were fewer deaths in vaccinated patients (40 vs 98, p<0.001).

Neither adverse effects nor costs were not discussed.

 Recommendations

Recommendation grade [A, B, C, D, E]  and level of evidence [I, II-1, II-2, II-3, III] are indicated after each recommendation. Citations in support of individual recommendations are identified in the guideline text.

 Validation

Recommendations and background papers were sent for external peer review. The National Advisory Committee on Immunization (NACI) recommends vaccination of individuals ³ 65 years, and those with chronic cardiorespiratory disease, cirrhosis, alcoholism, chronic renal disease, diabetes mellitus (adults), splenic disorders, or sickle cell disease. In contrast to the CTF recommendations, the NACI also recommends immunization of individuals with HIV and other immuno-suppressive conditions.

 Sponsors

The Canadian Task Force on Preventive Health Care developed this guideline with funding from Health Canada.

 Selected References

Source Document Other


Link to Full Text of this review

Link to Summary Table of Recommendations of this review

Link to Selected References list of this review

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