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
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.
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.
Sponsors
The Canadian Task Force on Preventive Health
Care developed this guideline with funding from Health Canada.
Selected References
Source Document
Wang, E.E.L. Administration of pneumococcal vaccine. In: Canadian Task
Force on the Periodic Health Examination. Canadian
Guide to Clinical Preventive Health Care. Ottawa: Health Canada, 1994;
386-395.
Other
Canadian Task Force on the Periodic Health Examination. The periodic
health examination, 1991 update: 2. Administration of pneumococcal vaccine.
Can
Med Assoc J 1991;144:665-71.