April 10, 1995

Counterpoint to 'Pneumococcal Vaccine After 1 5 Years of Use'-Reply

Author Affiliations

Seattle, Wash

Arch Intern Med. 1995;155(7):772-773. doi:10.1001/archinte.1995.00430070131016

In reply  The Dorothea Dix trial began in January 1973, and surveillance for pneumococcal disease among its participants ended in January 1976; the respective dates for the Kaiser Permanente trial are January 1974 and October 1976. At what point these studies ended is unclear, since they involved other important activities such as typing of the pneumococcal isolates and measurements of the subjects' serum antibodies, as well as the compilation, analysis, and interpretation of the data. Robert Austrian explicitly gives January 15, 1980, as the date of the preparation of his report, and we took that as the termination of the investigations.1 We, therefore, assumed, perhaps incorrectly, that the Food and Drug Administration did not have the results of these trials when it released the pneumococcal vaccine in November 1977. If that information was available, the Food and Drug Administration's approval is even more puzzling, since these studies failed to

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