The researchers believed that the contaminated vaccine batches were cleared up in 1963. A reader forwarded me a peer reviewed journal article discussing the legal proceedings at Lederle that suggest otherwise.

I have posted the abstract of the article below:

To date, the scientific literature and research examining SV40 and cancer-related diseases has been based upon an assumption that SV40 was not present in any poliovirus vaccine administered in the United States and was removed from the killed polio vaccine by 1963.

The basis for this presumption has been that the regulations for live oral polio vaccine required that SV40 be removed from the seeds and monovalent pools ultimately produced in the manufacturing process.

The Division of Biologic Standards permitted an additional two tissue culture passages -- from three to five -- in order to allow manufacturers the ability to remove this contaminant from the oral poliovirus vaccines then awaiting licensure. The confirmation of the removal by one drug manufacturer, Lederle, has been made public at an international symposium in January 1997, where its representatives stated that all of Lederle's seeds had been tested and screened to assure that it was free from SV40 virus.

However, in litigation involving the Lederle oral polio vaccine, the manufacturer's internal documents failed to reveal such removal in all of the seeds. The absence of confirmatory testing of the seeds, as well as testimony of a Lederle manager, indicate that this claim of removal of SV40 and the testing for SV40 in all the seeds cannot be fully substantiated.

These legal documents and testimony indicate that the scientific community should not be content with prior assumptions that SV40 could not have been in the oral polio vaccine.

Only further investigation by outside scientific and independent researchers who can review the test results claimed in the January 1997 meeting and who can conduct their own independent evaluations by testing all the seeds and individual mono-valent pools will assure that SV40 has not been present in commercially sold oral poliovirus vaccine manufactured by Lederle.

Anticancer Res 2000 Nov-Dec;20(6C):4745-9

A note about the SV40 virus:

According to Regis Vilchez, M.D., M.Sc., who has studied the SV40 virus,

"There are no commercial tests to evaluate SV40 infection. Serologic assays such as ELISA for SV40 have a low sensitivity. In addition, a recent FDA panel concluded that none of the current ELISA tests for SV40 are reliable for research or diagnostic. While the serum neutralizing antibody test is the recognized gold standard serologic test for SV40, it has low sensitivity and requires great labor.

"Therefore, molecular assays such as polymerase chain reaction (qualitative and quantitative) have been used to study the relation of SV40 infections and human malignancies. These tests are currently for research purposes but different laboratories (including ours) are working to establish them for commercial and diagnostic use. Indeed, this is one of the recommendations of the Institute of Medicine for studies of SV40 in humans. We hope they will be available to patients in the near future."

Additionally, the test is not performed by medical institutions because there is no therapy that can be offered to individuals who may test positive. Individuals who want to be tested for legal reasons should contact a lawyer who works with this issue. Lawyers may be more familiar with labs that may offer this type of service on a case-by-case basis.

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