Pneumococcal vaccine in the United States. A critical analysis.

The capsular polysaccharide pneumococcal vaccine approved by the Food and Drug Administration in November 1977 has been recommended for persons older than 2 years believed to be at high risk for pneumococcal disease, including those aged 50 years and older, those with chronic systemic illnesses, and those living in certain institutions. A critical review of the available evidence shows little documentation of an increased incidence of, or mortality from, pneumococcal disease for many of these suggested categories. Moreover, except for children with sickle cell disease, there is no convincing evidence that the vaccine is effective for the chronically ill, and unpublished controlled studies have demonstrated no benefit for ambulatory, elderly, or institutionalized patients. Thus, there is currently no information to support widespread pneumococcal vaccination in this country, and further investigations are needed to determine in what situations this vaccine is worthwhile.