Sold – Jonas Salk Provides Guidelines to Govern the Dissemination of Polio

In 1952, there were nearly 58,000 cases of polio in the United States, over 1/3 of these individuals were paralyzed and 3,000 died. Many of the victims were children and parents were terrified every summer during polio season. In 1947 Salk became head of the Virus Research Lab at the University of Pittsburgh, and began investigating the polio virus. On July 2, 1952, Salk tried a refined vaccine on children who’d already had polio and recovered. After the vaccination, their antibodies increased. He then tried it on volunteers who had not had polio, including himself, his wife, and their children. The volunteers all produced antibodies and none got sick.

In 1953 Salk reported his findings in The Journal of the American Medical Association. A nationwide testing of the vaccine was launched in April 1954 with the mass inoculation of school children. The results were excellent – 60 to 70 percent prevention – and Salk was highly praised. But suddenly, some 200 cases of the disease were caused by the vaccine and 11 people died. All testing was halted. It seemed that people’s hopes were dashed until investigators found that the disease-causing vaccine all came from one poorly made batch at one drug company. It was apparent that higher production standards were the answer and these were adopted and vaccinations resumed.

The impact was dramatic: In 1955 there were 28,985 cases of polio; in 1956, 14,647; in 1957, 5,894. By 1959, 90 other countries used Salk’s vaccine. In 1955, the National Institutes of Health created the Division of Biologics Standards, and gave it a separate new building, a "beefed up" research and regulatory staff, and a new director, Dr. Roderick Murray. It became the regulatory agency with the ultimate authority to enforce federal regulations for all vaccines manufactured and sold in the United States, One of the first major products the new organization was called upon to approve was the live oral poliovirus vaccine.

The World Health Organization [WHO] was interested in the vaccine, hoping to make it part of a campaign to immunize children throughout the world. On April 17, 1958, Dr. Murray wrote Salk to ask him what standards should be established for dissemination of the vaccine worldwide. “The WHO is convening a Study Group on ÔRecommended Requirements for Poliomyelitis Vaccine’ which will meet in Geneva…I have been asked to participate in this meeting…This is the first set of recommended requirements which the WHO group has embarked upon…It is obviously important that any requirements which are eventually published by the WHO group should not contain any recommendations of an arbitrary character which could impede the international shipment of American produced vaccine for instance, which met the provisions of our own regulations…Your suggestions would be appreciated.”

Salk responded thoughtfully and in detail, providing concrete guidelines to govern the international distribution of polio vaccine. He covered six topics, including setting of international standards, manufacturing requirements, production precautions, antigen potency, preservatives and adjuvants (additives that enhance effectiveness).

Typed Letter Signed on his University of Pittsburgh letterhead, Virus Research Laboratory, three pages, 21 May 1958, to Dr. Murray at the National Institutes of Health. We only quote a fraction of the letter here. “(1) International Standards – A reasonable standard for setting a standard of potency might be that concentration of antigen that would produce an antibody titer…of 1:8 or greater…This international standard could also be expressed in terms of an extinction value either in man or in animals…However, it would then be related to a level of performance that has meaning in terms that can be supported from field experience…(2) General Manufacturing Requirements – I would hope that no action would be taken at this time that would preclude the possibility that a vaccine could be made from virus grown in a continuously cultured cell-line…I would question the desirablilty of discussing the characteristics or properties of the cell that would be acceptable for this purpose at this time…(3)Productions Precautions – …information on antigenic potency at different stages of processing would be helpful and would reveal wherein potency losses occur…The proportion of monovalent material placed in the trivalent pools should be in accordance with the measurements of potency rather than volumes of fluid…(4) Antigenic Potency Tests – …As for vaccine potency acceptance levels, these should be determined on the basis of the quantity of antigen that produces at least a 75% conversion after two doses…(5) Preservatives – …The presence of preservatives has obvious advantages, but some can be selected from among those that have no demonstrable effect upon antigenicity, even when exposed to elevated temperatures…(6) Adjuvants – …In the case of polio, it is clear that rather low levels are effective…I have made no comments about strains of virus that might be included in a vaccine but would hope that this question has matured and that, in time, this will not have to be a subject of further discussion.”

Salk here provides a clear picture of the bacterialogical issues to be considered in disseminating polio vaccine worldwide, and gives his opinion on how to resolve them. We do not recall seeing another letter of this significance relating either to the conquest of polio or development any major vaccine.