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August 31, 1963

An Evaluation of the Carcinogenicity of Simian Virus 40 in Man

Author Affiliations

Bethesda, Md.

Medical Officer (Dr. Fraumeni) and Chief (Dr. Miller), Epidemiology Branch, and Head, Biometrics Analysis Section, Biometry Branch (Mr. Ederer), National Cancer Institute, National Institutes of Health, US Public Health Service.

JAMA. 1963;185(9):713-718. doi:10.1001/jama.1963.03060090045016

THE DISCOVERY that simian virus 40 (SV40) is oncogenic for certain newborn laboratory animals has raised the question of its carcinogenicity in man, particularly since this agent has been found in poliomyelitis and adenovirus vaccines. It is estimated that live SV40 has been injected into and ingested by hundreds of thousands, if not millions, of vaccines.1 Although clinical disease has not been reported, SV40 has low infectivity in man when administered by mouth with attenuated poliovirus vaccine1 and by the respiratory route.2 From the evidence presently available, however, it appears that the largest source of potential human infectivity by SV40 in the US was formalinized poliomyelitis vaccine containing the simian agent administered subcutaneously.3 The purpose of this report is to present a brief review of the literature and an epidemiologic study bearing on this problem.

Review of Literature  In 1960 Sweet and Hilleman4 reported the