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April 2, 1982

Pneumococcal Vaccine

JAMA. 1982;247(13):1809. doi:10.1001/jama.1982.03320380015010

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To the Editor.—  As one who served as chairman of the Advisory Panel on Bacterial Vaccines and Toxoids of the Bureau of Biologics at the time that licensure for the pneumococcal vaccine was recommended, I am obliged to respond to J. V. Hirschmann, MD, and Benjamin A. Lipsky, MD, who in their recent article (1981;246:1428) concluded: "The [Food and Drug Administration] licensed the pneumococcal vaccine for use in the general population before its benefits and risks were clearly delineated."Convincing clinical data of the efficacy of the pneumococcal vaccine were obtained by demonstrating its protection of humans who were naturally challenged by serious infections caused by the specific organisms against which the vaccine was constituted. The fact that the populations selected sometimes had to be unique to find a high incidence of bacteremic pneumococcal pneumonias (eg, African gold miners, New Guinea natives, military units) does not detract from their value