048 - Poliomyelitis Following Vaccination Against This Disease

This one is pretty short, but important. And closely related to the previous two posts (046 and 047). In this short article, J.P. Leake of the U.S. Public Health Service lists twelve cases of paralytic polio in children, but not just any polio.¹

As you may recall from the previous posts, there were a couple of experimental polio vaccines being tested around this time, and more than 11,000 people had received them. Brodie’s was allegedly completely inactivated, and Kolmer’s was still alive, but chemically attenuated enough that it rarely caused problems in monkeys. But when it is uncertain whether a given person will ever encounter the virus, let alone have a serious reaction to it (such as paralysis or death), any vaccine must be extremely safe in order to be worth giving to the whole population.

Brodie and Kolmer claimed their vaccines were so safe, but Leake presents evidence to the contrary (though without naming names). His report of 12 cases come from children aged 5 months up to 20 years. Six of these children died from their polio, and at least four were still paralyzed at the time of this study. And more importantly, they all came down with symptoms one to two weeks after receiving a dose of experimental vaccine.

By itself, this wouldn’t mean much, since they could’ve been exposed to the virus soon before (or soon after) receiving the vaccine, such that they came down with symptoms before immunity set in. But in these cases, they weren’t in areas where polio epidemics were happening, and they hadn’t been exposed to people from known epidemic areas. Even worse, their paralysis tended to begin in the same area of the spine where they had received the dose of the vaccine (which in itself was pretty interesting, as it implied that the virus travels through nerves rather than other bodily networks).

So it seems like these unfortunate children were infected by an improperly-prepared product. As Leake concludes:

"Although any one of these cases may have been entirely unconnected with the vaccine, the implication of the series as a whole is clear."¹

Of the studies that cite this paper, almost none disagree with its conclusion, though a few try to propose an alternative explanation (that the vaccine interfered with an immune response to an already-ongoing polio infection, for example). But a couple reviews summarize the history well:

"The Kolmer vaccine was known to contain a small amount of live virus capable of infecting monkeys, but it was presumed to be safe for humans on the basis of the unproved assumption that serial passage in monkeys had reduced its pathogenicity for man. This vaccine was clearly implicated as the cause of a number of cases of poliomyelitis. The Brodie vaccine, believed to be completely inactivated, was also suspected of causing several cases of poliomyelitis, but the evidence is much less convincing. At a meeting of the American Public Health Association in November 1935, reports were given on both vaccines. During the discussion of these reports, both vaccines were roundly condemned, particularly by Rivers of the Rockefeller Foundation and by Leake of the U.S. Public Health Service. Shortly thereafter, Leake published a list of vaccine-associated cases, and the vaccines were withdrawn from use."²

"Undaunted, Brodie fooled himself and convinced Park that the vaccine was safe, attempting to prove it by inoculating himself, Park, and a few laboratory technicians, after he had done a group of monkeys. He presented and published papers, invoking Park's name and cajoling him to serve as cosponsor. The Brodie-Park vaccine was thereby launched and the press began to take notice. Their enthusiastic coverage of events aroused the hopes of parents and physicians anxious to believe that protection from the crippling scourge might at last be at hand.

"Meanwhile, a competitor, John A. Kolmer of Philadelpha, called a press conference to announce that he had successfully tested a vaccine, different from Brodie's in that the virus in his vaccine was "live but devitalized," the attenuation achieved by the addition of sodium ricinoleate. In addition, Kolmer's vaccine was carried one step further, having been tested not only in monkeys and on himself and his two children but also on 22 other children. Reporters asked Park whether his vaccine also was ready for human use. Brodie had assured him it was and that tests on children were planned. The press whipped up the rivalry to the point where newspapers carried frequent progress reports resulting in antics in which each tried to outdo the other.

"The pressure of public expectation, the lack of restraint, and poor judgment soon forced both Brodie and Kolmer to undertake the inoculation of several thousand children under the poorest of circumstances for such an experiemnt. The experiment resulted in at least 12 vaccine-associated cases and six deaths. Another tragic incident, another immediacy, and the U.S. Public Health Service stepped in, ordering that both of these vaccines be withdrawn and destroyed. With this were sown the seeds for the stringent legal requirements for vaccine safety and efficacy which were to sprout some years in the future."³

 Citations:

1. Leake, J. P. Poliomyelitis Following Vaccination Against This Disease. Cal West Med 44, 141–142 (1936).

2. Meier, P. Safety Testing of Poliomyelitis Vaccine. Science 125, 1067–1071 (1957).

3. Schaeffer, M. William H. Park (1863-1939): His Laboratory and His Legacy. American Journal of Public Health 75, 1296 (1985).