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April 2, 1982

Pneumococcal Vaccine-Reply

JAMA. 1982;247(13):1809-1810. doi:10.1001/jama.1982.03320380015011

In Reply.—  The demonstration that pneumococcal vaccine protects young, healthy people in unique high-risk settings, such as South African gold mines, hardly justifies licensing the product specifically for use in the elderly or the chronically ill, a population comprising more than 54 million Americans. For this group there is as yet no evidence that the vaccine prevents pneumococcal disease.1,2 Among the 26 studies that the Bureau of Biologics used to evaluate the pneumococcal vaccine, only eight tested its efficacy; only one of these, in which 77 children with sickle cell anemia were immunized, demonstrated protection against pneumococcal infections for any of the targeted American populations. Since no responsible authority has recommended pneumococcal vaccination for the entire American public, it seems only reasonable, before licensing the vaccine, to demand evidence of its efficacy in the groups for whom it is intended.The vaccine's approval by the FDA initiated a predictable